Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Import & Export
Consent for Specimens
NOTE: As of October 6, 2017, the Peru country profile has been updated with new Clinical Trials Regulation, Supreme Decree No. 021-2017-SA. This regulation repeals Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru, Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru, and Supreme Decree No. 020-2015-SA.  However, administrative procedures initiated prior to the enactment of Supreme Decree No. 021-2017-SA on June 30, 2017, will continue to be governed by the previous regulations until their conclusion.
 
Also, while this profile currently references the 2012 Manual of Procedures for the Accomplishment of Clinical Trials in Peru, an update manual which will align with the new regulation is forthcoming, and this profile will be updated accordingly when it is released.
 
Peru
QUICK FACTS
Clinical trial application languageSpanish
Parallel regulatory and ethical review permittedNo
Clinical trial registration requiredYes
In-country sponsor presence/representation requiredYes
Age of minorsUnder 18
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
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SUMMARY
Overview
As per ResolutionNo089-2003-SA/DM, DecreeNo 021-2017-SA, INS CTManual, MAPRO·INS-001-V.02_Annexes, and Additional Resource (A), Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. The INS grants permission for clinical trials to be conducted in Peru in accordance with ResolutionNo089-2003-SA/DM, DecreeNo 021-2017-SA, INS CTManual, and MAPRO·INS-001-V.02_Annexes.

As indicated in DecreeNo 001-2003-SA and Additional Resources (B), (D), (E), and (F), the INS is an executive agency within the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)), and was granted authority to approve clinical trials by the MINSA in 2004. The INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) carries out the INS’s mandate to review, record, and authorize clinical trials, to regulate research in Peru, and to ensure the implementation of international ethical guidelines and good clinical practice (GCP) in the conduct of clinical trials.

According to Additional Resource (E), the Executive Office of Research within the OGITT is responsible for organizing and maintaining the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), the registration system for clinical trials, institutional ECs, research sites, and contract research organizations (CROs). (See Additional Resource (G) for detailed information on REPEC.)
 
In addition, the OGITT implements the INS’s objectives to promote, develop, and disseminate scientific and technological research, propose policies and standards, and provide health services to the Peruvian population.
 
For information on OGITT’s role in clinical trial oversight, see Articles 119 through 128 of DecreeNo 021-2017-SA.

Contact Information
Instituto Nacional de Salud
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú

Phone: 511 748 1111
Fax: Not Available
General Email: postmaster@ins.gob.pe

Application Submissions Contact Information
Instituto Nacional de Salud
Oficina General de Investigacion Y Transferencia Tecnologica
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú

Clinical Research Office Phone: 511 617 6200 Ext. 2191
Fax: Not Available
Clinical Research Office Email: consultaensayos@ins.gob.pe
 
ADDITIONAL RESOURCES
(A) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(B) (Website) About INS (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(C) (Presentation) Good Clinical Practice and Regulatory Aspects (April 2011)
Espiritu, Nora, Drug Information Association, Washington, DC
 
(D) (Website) Peru - National Institute of Health (INS) (Current as of October 4, 2017)
International Association of National Public Health Institutes (IANPHI), Atlanta, GA
 
(E) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(F) (Website) REPEC - Information for Citizens - About Clinical Trials in Peru (English and Spanish) (January 2016)
National Institute of Health, Ministry of Health
 
(G) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(H) (Website) INS Institutional Phone Directory (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Ministry Resolution No. 089-2003-SA/DM: Provides that Administrative Process Established by the Ministry Text of Administrative Procedures (TUPAs) is the Jurisdiction of the National Institute of Health (ResolutionNo089-2003-SA/DM - Spanish) (January 24, 2003)
Ministry of Health
 
Relevant Section: Article 1
 
(2) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo 001-2003-SA - Spanish) (January 9, 2003)
Ministry of Health
 
Relevant Sections: Title I and Title II (Chapters I and III)
 
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 6710, and 119-129
 
(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Section: Chapter III (Section 3.1)
 
(5) (Guidance) Update of Annexes of MAPRO-INS-001-V.02 (Resolution No 289-2016-J-OPE/INS) (MAPRO·INS-001-V.02_Annexes - Spanish) (October 24, 2016)
National Institute of Health, Ministry of Health
 
Relevant Sections: Annexes 1, 4, 15, 16, and 17
 
Regulatory Authority > Scope of Assessment
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SUMMARY

Overview
In accordance with ResolutionNo089-2003-SA/DM, DecreeNo 021-2017-SA, the INS CTManual, and MAPRO·INS-001-V.02_Annexes, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). As per DecreeNo 021-2017-SA, DecreeNo 016-2011-SA, and the INS CTManual, the scope of the INS’s assessment includes Phases I through IV clinical trials for pharmaceuticals including medicines, herbal medicines and other complementary products, dietetic products and sweeteners, biological products, and compounded (galenic) products.

As specified in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (B), the INS’s review and approval of a clinical trial application is dependent upon obtaining proof of ethics committee (EC) approval. Therefore, the INS and EC reviews may not be conducted in parallel. EC approval of the research protocol and informed consent form must be submitted as part of the clinical trial application dossier in order for the INS to conduct its review. Further, according to DecreeNo 021-2017-SA, the EC must be registered with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)). In addition, per DecreeNo 021-2017-SA, the sponsor must also ensure authorization by the research institution where the clinical trial will be carried out.

DecreeNo 021-2017-SA states that the IP must also meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru:

  • Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance
  • Is produced in Peru, is used in preclinical research, and complies with Ministerio de Salud del Perú (Ministry of Health of Peru) (MINSA))’s political and/or research priorities
  • Will serve to establish pharmaceutical therapeutic equivalence
  • Is considered a priority for the country’s public health or is within the scope of MINSA policies and/or research priorities
  • At the request of the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) (ANM), require a clinical trial to support its efficacy and safety for the health registry

Clinical Trial Review Process
As per the INS CTManual, the MAPRO·INS-001-V.02_Annexes, and Additional Resources (A), (B), and (E), the sponsor or his/her contract research organization (CRO) must submit the application electronically using the REPEC, at which time a registration code is assigned to the application.

According to DecreeNo 021-2017-SA and DecreeNo 016-2011-SA, the sponsor or his/her CRO must also obtain approval from the ANM to manufacture or import IPs in Peru. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)). As per DecreeNo 021-2017-SA, Peru’s INS must approve the clinical trial application prior to ANM’s approval of an IP. However, the INS does request ANM to assess the safety profile of the IP to be used in a clinical trial as part of its application review and approval process.

As per DecreeNo 021-2017-SA, the INS review and approval process for a clinical trial application takes 40 working days, including the 30 days for the ANM. Additionally, in clinical research using biological research products and in controversial situations that involve convening a technical commission, the maximum period for clinical trial authorization will be 60 working days, including the 45 days for the ANM’s safety profile evaluation.

DecreeNo 021-2017-SA states that the INS will be able to convene a technical commission of experts when controversial situations arise during the authorization process. Also, the sponsor has the right to appeal when the INS does not grant authorization.

DecreeNo 021-2017-SA states that the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) grants clinical trial authorization for the total period of time scheduled for its completion as indicated in the REPEC registration form submission.

Further, once the INS has completed the authorization process, the agency will post the following information regarding an authorized and unauthorized clinical trial on its website: study title, sponsor and investigators, IP, condition under study, study design, number of participants included and considered that have been considered within the World Health Organization test data set. (See the Clinical Trial Lifecycle topic, Submission Process, Submission Content, and Timeline of Review subtopics for detailed submission requirements.)

ADDITIONAL RESOURCES
(A) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru
 
(B) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: 1. Clinical Trial Authorization – Requirements
 
(C) (Website) REPEC - Information for Citizens - About Clinical Trials in Peru (English and Spanish) (January 2016)
National Institute of Health, Ministry of Health
 
(D) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(E) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(F) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of October 4, 2017)
Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Ministry Resolution No. 089-2003-SA/DM: Provides that Administrative Process Established by the Ministry Text of Administrative Procedures (TUPAs) is the Jurisdiction of the National Institute of Health (ResolutionNo089-2003-SA/DM - Spanish) (January 24, 2003)
Ministry of Health
 
Relevant Section: Article 1
 
(2) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 2, 6, 7, 810 40, 74, 52, 67-74, 94 and 119-121
 
(3) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
 
Relevant Sections: Title I (Article 2) and Title II (Chapters I and V)
 
(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (section 3.1) and Annex 1
 
(5) (Guidance) Update of Annexes of MAPRO-INS-001-V.02 (Resolution No 289-2016-J-OPE/INS) (MAPRO·INS-001-V.02_Annexes - Spanish) (October 24, 2016)
National Institute of Health, Ministry of Health
 
Relevant Sections: Annexes 1, 4, and 15
 
Regulatory Authority > Regulatory Fees
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SUMMARY

Overview
As per DecreeNo 021-2017-SA and Additional Resource (A), the sponsor or his/her contract research organization (CRO) is responsible for paying a fee to the National Institute of Health of Peru (Instituto Nacional de Salud (INS)) to submit a clinical trial application for authorization. Per DecreeNo 021-2017-SA, in the case of multicenter clinical trials, payment must be made by each of the participating research centers in Peru. Additionally, INS payment is required to modify the trial as follows: to increase the number of research centers participating in a study; to change the sponsor or CRO under contract; to change the principal investigator; to request a time extension for the trial; to request authorization to change the trial name; or to request authorization to amend a report.

According to Additional Resource (A), the INS processing fees (in Peruvian Soles) are as follows:

  • Clinical trial authorization: S /. 1775.00
  • Renewal of clinical trial authorization: S /. 839.50
  • Clinical trial extension: S /. 839.50
  • Extension of research center: Evaluation of Clinical Trial by additional center, at local level (Lima): S /. 401.50; Evaluation of Clinical Trial by additional center, inland (Provinces): S /. 730.00

See DecreeNo 021-2017-SA and Additional Resource (A) for detailed information on INS clinical trial-related costs.

ADDITIONAL RESOURCES
(A) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 67, 76, 78-80,87 and 88
 
Ethics Committee > Ethics Committee
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SUMMARY
Overview
As set forth in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A), (B), and (C), Peru requires clinical trial approval from an institutional level ethics committee (EC) that is registered with the National Institute of Health (Instituto Nacional de Salud (INS))’s Peruvian Registry of Clinical Trials in Peru (REPEC). There are no stated requirements regarding which EC the sponsor should choose to conduct the clinical protocol review. See the INS CTManual and Additional Resource (C) for detailed instructions, and the application form required to register an institutional EC.

Peru’s Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Etica en Investigación del Instituto Nacional de Salud (CIEI-INS)) does not approve clinical trials.

Institutional EC Composition
As delineated in DecreeNo 021-2017-SA, institutional ECs should consist of at least five (5) members represented by a multidisciplinary group of health professionals and community members, including: 
  • Persons with scientific expertise in the health field, including those with expertise in behavioral or social sciences
  • Persons with expertise in ethical matters
  • Persons with expertise in legal matters
  • Community representatives, whose primary function is to share their views on the communities where the research participants are likely to come from
One (1) titular member, at least, must be from the community and not belong to the field of health or to the research institution. In addition, all members must have at least one certificate of basic training in research ethics and one of its members must have training in bioethics. The list of all members must be publically accessible. Also, the EC should seek the assistance of expert consultants on different topics when it lacks the knowledge and experience necessary to evaluate the protocol.
 
Terms of Reference, Review Procedures, and Meeting Schedule for Institutional ECs
DecreeNo 021-2017-SA and the INS ECManual state that infrastructure requirements for the operation of institutional ECs must be met including insuring work environments that guarantee confidentiality and computer equipment with sufficient capacity, and providing administrative staff. Each EC must be registered with the INS’s REPEC, and this registration must be renewed every three (3) years.
 
ECs must also have stated rules  and prepare a procedures manual that is approved by the research institution; seek specialist(s) advice on diseases or methodologies outside the EC’s expertise; and ensure that alternate committee members have been selected. The rules should establish composition and requirements to be fulfilled by its members; meeting frequency; and specific quorum requirements. The procedures manual should provide filing dossier administrative requirements, and procedures for monitoring authorized research protocols, for the preparation and approval of meeting minutes, and for filing related documentation. Further, when an EC member has a conflict of interest, he/she must be replaced by an alternate member for the review and this must be documented in the meeting minutes. See Title IV, Chapter 7 of DecreeNo 021-2017-SA for detailed EC requirements.
 
ADDITIONAL RESOURCES
(A) (Website) Norms (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(B) (Website) Requirements for Project Evaluation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(C) (Website) Registration of Institutional Research Ethics Committee (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(D) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(E) (Website) Schedule and Members (CIEI-INS) (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(F) (Website) Search of Registered Institutional Ethics Committees (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(G) (Presentation) Good Clinical Practice and Regulatory Aspects (April 2011)
Espiritu, Nora, Drug Information Association, Washington, DC
 
(H) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(I) (Website) REPEC - Information for Citizens - About Clinical Trials in Peru (English and Spanish) (January 2016)
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 40, 59, 61-66, 71, 102, and Complementary Provisions - Final (Eighth)
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Section 3.2) and Annex 17
 
(3) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish) (January 2013)
National Institute of Health, Ministry of Health
 
Relevant Sections: Objectives, Operating Definitions, Chapter I, Chapter II, Annex A, and Annex B
Ethics Committee > Scope of Review
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SUMMARY
Overview
According to DecreeNo 021-2017-SA, the INS ECManual, and Additional Resources (A) and (B), the primary scope of information assessed by institutional ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

As per DecreeNo 021-2017-SA and the INS ECManual, the ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. When a clinical trial is proposed for subordinate groups (e.g. students, health workers, employees, military members, police, prisoners, etc.), one or more members of the population under study, or another person within this community capable of guarding the conditions and human rights that correspond to the group in question, should participate in the Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Etica en Investigación (CIEI) review. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these populations).

DecreeNo 021-2017-SA and the INS ECManual also state that National Institute of Health (Instituto Nacional de Salud (INS))-registered institutional ECs are responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards. They must also conduct regular monitoring, with the frequency being based on the degree of risk to participants, but no less than once a year, and suspend or cancel the trial when participants are exposed to uncontrolled risk. See DecreeNo 021-2017-SA and the INS ECManual for detailed ethical review guidelines.

Role in Clinical Trial Approval Process
As per DecreeNo 021-2017-SA, the INS CTManual, the INS ECManual, and Additional Resource (D), an INS-registered EC must approve the clinical trial protocol and informed consent form prior to the sponsor or his/her contract research organization (CRO) submitting the clinical trial application to the INS. The INS and EC reviews may not be conducted in parallel.
 
As per the INS ECManual, the EC typically reviews and approves submitted applications between 20 and 40 days depending on the project’s complexity. The INS ECManual also specifies that the approval of a new application is valid for one (1) year. All approved studies running for more than one (1) year are subject to continuing annual review by the respective EC. An application for continuing EC review must be made one (1) month prior to the expiration of the previous approval. (See the Clinical Trial Lifecycle topic, Submission Process and Timeline of Review subtopics for detailed submission process and timeline details.)
 
ADDITIONAL RESOURCES
(A) (Website) Norms (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(B) (Website) Requirements for Project Evaluation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(C) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru
 
(D) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 24, 58 , 60, 67 and 70
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (section 3.1) and Annex 1
 
(3) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish) (January 2013)
National Institute of Health, Ministry of Health
 
Relevant Sections: Objectives, Operating Definitions, Chapter I, Chapter II, Annex A, and Annex B
 
Ethics Committee > Ethics Committee Fees
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SUMMARY

No relevant provisions

 

ADDITIONAL RESOURCES

No additional resources

 

REQUIREMENTS

No applicable regulatory requirements

 

Ethics Committee > Authorizing Body
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SUMMARY
Overview
As set forth in DecreeNo 001-2003-SA, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is the central body responsible for the oversight, promotion, and coordination of research. The INS is a decentralized public agency of the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)).

Registration, Auditing, and Accreditation
As per DecreeNo 021-2017-SA, the INS CTManual and Additional Resources (A) and (B), the Executive Office of Research within the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) is responsible for authorizing institutional ethics committees (ECs) registered in the INS’s Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)).
 
DecreeNo 021-2017-SA states that accreditation is temporary and must be renewed every three (3) years. Accreditation requirements to be completed include the following:
  • Application for accreditation/renewal of accreditation sent to INS
  • Resolution/decision obtained from highest authority within institution that empowers EC operation
  • Copy of institutionally approved EC regulations and its Manual of Procedures
  • Affidavit indicating compliance with accreditation standards in the INS’s forthcoming Manual of Clinical Trial Procedures (which will replace the INS CTManual)
  • Curriculum vitaes signed by each EC member
Accreditation will be granted based on OGITT’s evaluation of the documentation presented and verification of the EC‘s compliance with the accreditation standards established in the INS’s forthcoming Manual of Clinical Trial Procedures, which will replace the INS CTManual. A preliminary version of the Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Etica en Investigación (CIEI) accreditation standards compliance statement to be completed by ECs is available in Additional Resource (D).
 
Per DecreeNo 021-2017-SA, a National Registry of Institutional Committees for Accredited Research Ethics will be created under this regulation. DecreeNo 021-2017-SA further grants a grace period of one (1) year following the approval of the new Manual of Clinical Trial Procedures for ECs to comply with the accreditation requirements listed above.
 
Additionally, the INS CTManual provides detailed information on the inspections that the INS-registered ECs may be subject to before, during, and after the registration of an EC.
 
ADDITIONAL RESOURCES
(A) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(B) (Website) Registration of Institutional Research Ethics Committee (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(C) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo 001-2003-SA - Spanish) (January 9, 2003)
Ministry of Health
 
Relevant Section: Title I, Title II (Chapters I and III)
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Section 3.3.4 and Annex 20
 
(3) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Article 63 and Complementary Provisions - Final (Eighth)
 
Clinical Trial Lifecycle > Submission Process
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SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (B), Peru requires the sponsor or his/her contract research organization (CRO) to obtain clinical trial authorization from Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) and ensure his/her principal investigators (PIs) obtain ethics committee (EC) approval from an INS-registered EC. DecreeNo 021-2017-SA also states that if the sponsor is not based in Peru, it is a statutory requirement for the sponsor to appoint a legal representative in the country who channels all communication with the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) for the trial’s duration, unless such responsibility is delegated to a CRO.

According to DecreeNo 021-2017-SA and the INS CTManual, the INS and EC reviews may not be conducted in parallel. The INS-registered EC must first approve the research protocol and informed consent form (ICF), and the sponsor or his/her CRO must submit this information as part of the application dossier in order for the INS to conduct its review. For details on submitting protocol amendments, refer to Notice No001-2017-OGITT/INS and Additional Resource (D). (See the Submission Content subtopic for detailed submission requirements).

Delivery Address for Clinical Trial Application
Instituto Nacional de Salud
Oficina General de Investigacion Y Transferencia Tecnologica
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú

Clinical Research Office Phone: 511 617 6200 Ext. 2191
Fax: Not Available
Clinical Research Office Email: consultaensayos@ins.gob.pe

Assembly and Number of Copies
Based on information provided in DecreeNo 021-2017-SA, the INS CTManual, the MAPRO·INS-001-V.02_Annexes, and Additional Resources (B) and (C), the sponsor or his/her CRO must submit a request for clinical trial authorization electronically using the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time a registration code is assigned to the application. As per Additional Resource (B), one copy of the application must be submitted to the INS in an arch lever file (spring file folder) with the documents paginated and labeled using dividers, and ordered as indicated in the requirements listed in DecreeNo 021-2017-SA, , the INS CTManual, and Additional Resource (B). The application and related materials must be sent to the INS within seven (7) days of receiving the registration code. If the seven (7) day timeframe is exceeded, the application will be discarded, and another application must be submitted electronically to obtain a new registration code and initiate the process again.

Clinical Trial Application Language Requirements
As delineated in DecreeNo 021-2017-SA and the INS CTManual, the clinical trial application and accompanying material must be provided in Spanish. Any document not in Spanish must be submitted with a corresponding translation. Further, per DecreeNo 021-2017-SA, the research protocol and updated investigator’s brochure must be written in Spanish, and in the original language if different from Spanish, in both printed and electronic media. If the protocol title is written in English, a single title in Spanish must be assigned for all purposes. The ICF must also be written in Spanish, and in the language the research participant identifies as his/her own. This requirement is also applicable to the protocol and ICF amendments. In addition, research and complementary investigational products media labeling must be printed in indelible ink in Spanish or English.
 
ADDITIONAL RESOURCES
(A) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru
 
(B) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Requirement 1
 
(C) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
 
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 34, 40, 59, 61, 63, 67, 70, 71, 88, 91, Annex 1, and Complementary Provisions Final
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1, and Annex 17
 
(3) (Guideline) Notice No. 001-2017-OGITT/INS Notification of Deviations to the INS OGITT (Notice No001-2017-OGITT/INS - Spanish)(July 19, 2017)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
 
(4) (Guidance) Update of Annexes of MAPRO-INS-001-V.02 (Resolution No 289-2016-J-OPE/INS) (MAPRO·INS-001-V.02_Annexes - Spanish) (October 24, 2016)
National Institute of Health, Ministry of Health,
 
Relevant Section: Annex 15
 
Clinical Trial Lifecycle > Submission Content
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SUMMARY
Overview
As set forth in DecreeNo 021-2017-SA, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) requires the sponsor or his/her contract research organization (CRO) to apply for clinical trial authorization, and the principal investigator (PI) to apply for approval from an INS-registered ethics committee (EC) to conduct a clinical trial.

INS Requirements
As specified in DecreeNo 021-2017-SA, a clinical trial application submission must include the following documents:
  • Application for clinical trial authorization per Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) registration form
  • Approval(s) issued by legal representative of institution(s) where research will be conducted
  • EC approval of the research protocol and informed consent form (ICF)
  • Research protocol in Spanish, and in the original language, if different from Spanish (see Annex 1 in DecreeNo 021-2017-SA)
  • ICF (see Annex 4 in DecreeNo 021-2017-SA)
  • Investigator’s Brochure (IB) updated version in Spanish, and in the original language, if different from Spanish (See Annex 2 in DecreeNo 021-2017-SA)
  • Sponsor affidavit indicating fulfillment of responsibilities
  • Affidavit stating no conflict of financial interest signed by the sponsor/CRO and the PI
  • Affidavit signed by PI and sponsor on preparation of research institution for trial
  • In the case of foreign sponsor: copy of proof of delegation of functions to the sponsor representative authenticated with The Hague Apostille
  • Affidavit signed by PI that indicates compliance with the regulatory obligations and requirements
  • Affidavit on compensation for participants signed by the sponsor/CRO and PI (covers budget and expenses for any trial-related injuries) (See Annex 9 in the INS CTManual)
  • Copy of current insurance policy purchased by the sponsor
  • List of clinical trial supplies (See Annex 10 in the INS CTManual)
  • Information related to the investigational product (IP) quality (see Annex 5 in DecreeNo 021-2017-SA)
  • Copy of curriculum vitaes (CVs) for the PI, co-investigator(s), and rest of research team
  • Copy of documents demonstrating training in Good Clinical Practices and Research Ethics in human beings for the entire research team within the past three (3) years
  • Detailed national budget total for trial
  • Copy of current record of authorized research institution(s) for clinical trials
  • Payment receipt for research site registration; in the case of multicenter trials, receipts must be provided to demonstrate each research site has made separate payment
Refer to DecreeNo 021-2017-SA for detailed submission information. Also see the Submission Process subtopic for additional submission requirements.

Institutional EC Requirements
As per the INS ECManual and Additional Resource (C), institutional ECs generally require PIs to submit the following documentation for ethics approval:
  • Letter from the PI to the EC Chairman
  • Two (2) copies of the Basic Format Application (see Annex A in the INS ECManual)
  • Two (2) copies of the research protocol (in printed and electronic format with date and version number)
  • Two (2) copies of the ICF (in printed and electronic format with date and version number)
  • One (1) copy of PI and co-investigator(s) CV(s)
  • One (1) copy of the PI statement
  • One (1) copy of the Declaration of the PI and research center director/research institution head
  • One (1) copy of the Declaration of the PI and co-investigators
  • One (1) copy of the Declaration of financial details and potential conflicts of interest
  • One (1) copy of the Certainty of Approval of the Protocol, by an institutional research committee to ensure scientific validity
  • One (1) copy of signed Commitments of the Investigator Form
  • List of requirements for submission of projects
  • One (1) copy of the Form for the Use of Cryopreserved Biological Samples in the INS bank or other institutions, if applicable
  • Payment receipt for the draft assessment
  • Two (2) copies of the IB
  • One (1) copy of sponsor’s insurance policy (original and, if applicable, a version with a certified Spanish translation)
  • One (1) copy documenting the PI’s training in good clinical research ethics
Clinical Protocol
According to DecreeNo 021-2017-SA, the clinical protocol should contain the following elements:
  • Protocol code
  • Sponsor or CRO and PI/co-investigator(s) names and contact information
  • Protocol title and summary
  • Investigational Product description (See Investigational Products topic for detailed coverage of this subject)
  • Form, dosage, route, method, and frequency of administration; treatment period
  • Disease/injury problem and background research
  • Justification of clinical trial
  • Objectives
  • Methodology (including trial design, random selection method, and blinding level)
  • Eligibility criteria and monitoring (including participant selection/withdrawal)
  • Participant treatment
  • Description of test development methods and evaluation of response (quality control)
  • Adverse event reporting requirements (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Ethical considerations
  • Researcher(s) responsibilities and liabilities
  • Statistics and methods to track trial data
  • Timetable specifying study phases and runtimes
  • Investigator and sponsor plans for publicizing the results, including to research participants
  • References and annexes
For complete protocol requirements, refer to Annex 1 of DecreeNo 021-2017-SA.
 
ADDITIONAL RESOURCES
(A) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru
 
(B) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Requirement 1
 
(C) (Website) Requirements for Project Evaluation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(D) (Website) Registration of Institutional Research Ethics Committee (Last Updated December 29, 2015)
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 40, 59, 63, 67, 71, Complementary Provisions Final and Annex 1
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1, Annex 5, Annex 6), Annex 7, Annex 8, Annex 10, and Annex 17
 
(3) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish) (January 2013)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter II, Annex A, Annex B, Annex C, and Annex D
 
Clinical Trial Lifecycle > Timeline of Review
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SUMMARY
Overview
Based on DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (B), the National Institute of Health (Instituto Nacional de Salud (INS))’s review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics committee (EC) approval from an INS-registered EC. Therefore, the INS and EC reviews may not be conducted in parallel.

INS Approval
Clinical Trial Application Submission
As per DecreeNo 021-2017-SA, the INS review and approval process for a clinical trial application takes 40 working days, including the 30 days for the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) (ANM)’s safety profile and the investigational product (IP) quality evaluations. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)). Additionally, in clinical research biological research products and in controversial situations that involve convening a technical commission, the maximum period for clinical trial authorization is 60 working days, including the 45 days for the ANM’s safety profile evaluation. For specific information on pre-submission registration requirements, see Clinical Trial Lifecycle topic, Submission Process subtopic.
 
Per DecreeNo 021-2017-SA, the Investigator’s Brochure (IB) and the protocol are also simultaneously forwarded to the ANM in order to obtain a safety evaluation of the IP. DecreeNo 021-2017-SA states that the ANM must provide a technical opinion within 30 days.

DecreeNo 021-2017-SA states that the OGITT grants clinical trial authorization for the total period of time scheduled for its completion as indicated in the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) registration form submission.

Ethics Committee Approval
The EC review and approval process timeline will vary by institution.
 
ADDITIONAL RESOURCES
(A) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru
 
(B) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: 1. Clinical Trial Authorization
 
(C) (Website) REPEC - Information for Citizens - About Clinical Trials in Peru (English and Spanish) (January 2016)
National Institute of Health, Ministry of Health
 
(D) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(E) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health of Peru, Ministry of Health of Peru
 
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 8, 40, 59, 63, 69, 70, 71, and Complementary Provisions Final
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1, and Annex 17
 
Clinical Trial Lifecycle > Trial Initiation
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SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (B), a clinical trial can only commence after the sponsor or his/her contract research organization (CRO) receives authorization from Peru’s National Institute of Health (Instituto Nacional de Salud (INS)), which is dependent on ethics committee (EC) approval from an INS-registered EC. Therefore, the INS and EC reviews may not be conducted in parallel. No waiting period is required following the applicant’s receipt of these approvals.

As per DecreeNo 021-2017-SA and DecreeNo 016-2011-SA, the sponsor or his/her CRO is required to obtain an import license for the shipment of an investigational product to be used in the trial from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) (ANM). (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)). (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the DecreeNo 021-2017-SA, all investigators must possess appropriate qualifications, training, and experience. Furthermore, the trials should be conducted in compliance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs).
 
Clinical Trial Agreement
According to DecreeNo 021-2017-SA, the sponsor and principal investigator (PI) must sign an affidavit on the preparation of the research center where the clinical trial will be executed. A preliminary version of the affidavit is available in Additional Resource (C). Further, the sponsor must sign an affidavit indicating that he/she will fulfill the responsibilities delineated in DecreeNo 021-2017-SA; the PI must also sign an affidavit indicating his/her compliance with obligations and requirements in this regulation; and, both the sponsor and the PI must sign an affidavit establishing that there is no conflict of financial interest in executing the trial.
 
EC Confirmation of Review and Approval
DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A) mandate that the sponsor or his/her CRO obtain written confirmation of EC review and approval from an INS-registered EC prior to the trial’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).
 
Peruvian Clinical Trials Register
As per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (B) and (E), the sponsor or his/her CRO must register the clinical trial application electronically using the INS’s Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time, a registration code is assigned to the application. For details on submitting protocol amendments, refer to No001-2017-OGITT/INS and Additional Resource (K).
 
According to Additional Resource (J), REPEC was accredited by the Pan American Health Organization (PAHO)/World Health Organization (WHO) in 2016 to as an official member of the WHO registry on May 6, 2016.

Data Safety Monitoring Board
DecreeNo 021-2017-SA requires the sponsor to provide information on the Data Safety Monitoring Board (DSMB) including its composition, a summary of its role and notification procedure, a statement of independence from the sponsor and any conflicts of interest. Additionally, the sponsor should specify where to find other details about the by-laws not included in the protocol, or, explain why a DSMB is not necessary.
 
ADDITIONAL RESOURCES
(A) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru
 
(B) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Requirement 1
 
National Institute of Health, Ministry of Health
 
(D) (Website) General Directorate of Medicines, Supplies and Drugs (Spanish) (Current as of October 4, 2017)
Ministry of Health
 
(E) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
National Institute of Health, Ministry of Health
 
(G) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 1.27 and 3.3
 
(H) (Website) REPEC - Registration of a Clinical Trial - Authorization (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(I) (Website) REPEC - Sponsor, CRO, Trial Site and Ethics Committee (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(J) (Document) REPEC - Accreditation Letter from PAHO/WHO (WHO Charter) (Spanish) (May 6, 2016)
National Institute of Health, Ministry of Health
 
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 2, 8, 40, 51, 52, 59, 63, 67, 70, 71, 94, Complementary Provisions Final, and Annex 1
 
(2) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
 
Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)
 
(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1, Annex 2, Annex 10, and Annex 17
 
(4) (Guideline) Notice No. 001-2017-OGITT/INS Notification of Deviations to the INS OGITT (Notice No001-2017-OGITT/INS - Spanish) (July 19, 2017)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
 
Clinical Trial Lifecycle > Safety Reporting
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
According to DecreeNo 021-2017-SA and the INS CTManual, the following definitions provide a basis for a common understanding of Peru’s safety reporting requirements:
  • Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
  • Adverse Drug Reaction (ADR) – Any noxious and unintended response in a participant to an investigational medicinal product which is related to any dose administered to that participant
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) or Unexpected ADR – Any AE, ADR, or unexpected ADR that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Unexpected Adverse Drug Reaction – An adverse reaction where the nature or severity is inconsistent with the applicable product informationSuspected Unexpected and Serious Adverse Reaction (SUSAR) – Any serious AE/ADR in which there is at least a reasonable possibility of a causal relationship with the investigational product (IP) and the nature and severity of the event/reaction is not described in the investigator’s brochure and/or the fact sheet technique.
Reporting Requirements for AEs/ADRs
Investigator Responsibilities
According to DecreeNo 021-2017-SA, the principal investigator (PI) is responsible for monitoring the safety of the investigational product (IP).
 
As specified in DecreeNo 021-2017-SA, the PI is responsible for notifying the sponsor or his/her contract research organization (CRO) or the ethics committee (EC) of any SAEs/SADRs and SUSARs within a period not exceeding one (1) calendar day from the date the event occurs, or, the PI becomes aware of the incident. The PI must also follow-up with a detailed written report
 
Furthermore, the PI must inform the sponsor/CRO and the EC of the following:
  • Any SAE/SADR that has occurred to a participant following the trial’s completion
  • Any non-serious AEs/ADRs identified as determinants of safety assessments in the protocol within the periods specified
Lastly, the PI must provide the sponsor/CRO, the EC, and the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) with any additional safety information requested.

Sponsor Responsibilities
According to DecreeNo 021-2017-SA, the sponsor must ensure and monitor reporting of AEs/ADRs, SAEs/SADRs, and SUSARs and provide these reports to the INS’s OGITT.
 
Per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (B) and (C), the sponsor/CRO is required to submit all expected and unexpected SAE/SADR reports electronically through the Serious Adverse Events Virtual Reporting System (Sistema de Reporte de Eventos Adversos Serios) (REAS-NET) to the INS’s OGITT within seven (7) business days from the occurrence of the incident, or, as soon as the sponsor is aware of the incident. The submitted information above must be updated with any additional relevant information within eight (8) business days. A printed copy of the report (see the Adverse Event Reporting Form (Annex 11) of the INS CTManual or Additional Resource (B)) must be submitted to the EC and the INS in the original language, and, if necessary, translated into Spanish.

In addition, per DecreeNo 021-2017-SA, the sponsor/CRO must notify the OGITT, the ECs, and the PIs within a maximum period of seven (7) calendar days of any findings that could adversely affect the safety of research participants, have an impact on the conduct of the study, or alter the benefit/risk balance. This report should be prepared independently and separately from other required AE/ADR submission deadlines outlined in this subtopic.
 
As delineated in DecreeNo 021-2017-SA, the sponsor is also required to submit electronically on a quarterly or semi-annual basis to the OGITT, Council for International Organizations of Medical Sciences (CIOMS) SAE/SADR and SUSAR reports occurring internationally, whether they have occurred in the authorized trial, in other trials with the same IP, or, in a context of different use.
(See the Investigational Products topic for additional information on IPs.)
 
Further, per DecreeNo 021-2017-SA, the INS’s OGITT must notify the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) (ANM) of any SAEs/SADRs and SUSARs caused by an IP being used in an authorized trial in Peru within a maximum period of 15 working days after receiving notification about the incident. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)).

See DecreeNo 021-2017-SA and Additional Resources (B) and (C) for detailed sponsor/CRO reporting requirements.
 
Form Completion & Delivery Requirements
As per DecreeNo 021-2017-SA, the INS CTManual, and Additional Resource (A), all AEs/ADRs, SAEs/SADRs, and SUSARs must be reported electronically by the sponsor/CRO using the INS’s (REAS-NET). All SAEs/SADRs and SUSARs must be reported on the CIOMS Form I (Additional Resource (D)).

Data Safety Monitoring Board
DecreeNo 021-2017-SA requires the sponsor to provide information on the Data Safety Monitoring Board (DSMB) including its composition, a summary of its role and notification procedure, a statement of independence from the sponsor and any conflicts of interest. Additionally, the sponsor should specify where to find other details about the by-laws not included in the protocol, or, explain why a DSMB is not necessary.
 
ADDITIONAL RESOURCES
(A) (Website) Serious Adverse Events Virtual Reporting System (REAS-NET) (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(B) (Website) Serious Adverse Event Reporting (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
National Institute of Health, Ministry of Health
 
Relevant Section: 4
 
(D) (Form) CIOMS Form I (Date Unavailable)
Council for International Organizations of Medical Sciences
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Article 2, 40, 52,108-111
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Section 3.1), Annex 2, Annex 6, and Annex 11
 
Clinical Trial Lifecycle > Progress Reporting
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A), (B), and (C), the sponsor or his/her contract research organization (CRO) is responsible for submitting progress and final reports to the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)). As per DecreeNo 021-2017-SA, the principal investigator (PI) is responsible for submitting clinical trial progress and final reports to the research institution and the institutional ethics committee (EC).

Interim/Progress Reports
As delineated in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (C), the sponsor or his/her CRO must submit the progress report for each institution in which a trial is conducted from the date of authorization of the study to the INS’s OGITT. The report should be submitted quarterly or semi-annually, according to the resolution of the authorization issued, and per the format set forth in the Clinical Trial Progress Report form (See Annex 12 in the INS CTManual and Additional Resources (A) and (C)).
 
DecreeNo 021-2017-SA further states that the progress report must be sent in print and electronic media, and include the following information:
  • Number of patients enrolled in the study and status (e.g., in treatment; retired from study; completed study; or, who are not ready to enroll)
  • Summary of serious adverse events/adverse drug reactions (SAEs/SADRs) and non-serious AEs/ADRs related to the investigational product (IP), and deviations occurring in the corresponding period
Final Report
As delineated in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (B) and (C), the sponsor or his/her CRO must submit research site final reports for each of the centers within 30 calendar days following the closing visit made by the monitor.
 
DecreeNo 021-2017-SA also states that the final report should include the following information:
  • Number of screened, enrolled, retired patients who completed the trial
  • Summary of serious SAEs/SADRs and non-serious AEs/ADRs related to the IP, and deviations occurring since the date of the last progress report
Further, according to DecreeNo 021-2017-SA, the INS, in coordination with the sponsor, must publish the results of authorized and performed clinical trials through the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)). The sponsor is also obligated to submit an article to a national or international scientific journal that strictly reflects the final report submitted to the INS’s OGITT. The published article must also be sent to the INS and the research institution in print and electronic media.
 
National Final Report
Per DecreeNo 021-2017-SA, national final reports should be submitted within 60 calendar days following the date of the final report submission of the last research center. For clinical trials performed only in Peru, the report must be submitted within a maximum period of six (6) months following the trial’s conclusion.
 
DecreeNo 021-2017-SA also states that the national final report should include the following information:
  • Number of screened, enrolled, retired patients who completed the trial
  • Summary of serious SAEs/SADRs and non-serious AEs/ADRs related to the IP, and deviations that occurred
  • For trials performed only in Peru, the report should also include the final results and conclusions of the trial
International Final Report
As delineated in DecreeNo 021-2017-SA, international final reports should be submitted within 12 months following the completion of the last clinical trial in all international research centers. The reports should comply with the format set forth in the Clinical Trial Final Report form.
 
For detailed progress and final report requirements, see DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (B) and (C).
 
ADDITIONAL RESOURCES
(A) (Website) Clinical Trial Progress Report (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(B) (Website) Clinical Trial Final Report (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(C) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(D) (Website) Peruvian Clinical Trials Registry (REPEC) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Articles 2, 40, 52, and 104-107
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Section 3.1), Annex 12, and Annex 13
 
(3) (Guideline) Notice No. 001-2017-OGITT/INS Notification of Deviations to the INS OGITT (Notice No001-2017-OGITT/INS - Spanish)) (July 19, 2017)
General Office of Research and of Health Technology Transfer, National Institute of Health, Ministry of Health
 
Sponsorship > Definition of Sponsor
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
As per DecreeNo 021-2017-SA, the sponsor is defined as an individual, group of individuals, company, institution, or organization, with legal representation in the country and duly registered in the corresponding public registries, who takes ultimate responsibility for the initiation, maintenance, conclusion, and financing of a trial. When an independent researcher initiates and takes full responsibility for a clinical trial, then he/she assumes the role of sponsor.
 
DecreeNo 021-2017-SA also states that if the sponsor is not based in Peru, it is a statutory requirement for the sponsor to appoint a legal representative who channels all the communication with the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) for the trial’s duration.
 
DecreeNo 021-2017-SA and the INS CTManual state that a sponsor can authorize a contract research organization (CRO) with legal status and an office in Peru to carry out certain work and obligations regarding the trial. However, the sponsor is ultimately responsible for the execution of the research protocol and the results of the trial. In addition, the CRO must register with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) and annually report their clinical trial activities. See DecreeNo 021-2017-SA and the INS CTManual for registration instructions and the application form.
 
ADDITIONAL RESOURCES
(A) (Website) REPEC - Sponsor, CRO, Trial Site and Ethics Committee (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 41 - 45
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter 3 (Section 3.2) and Annex 16 (Application for Registration of Contract Research Organization)
 
Sponsorship > Trial Authorization
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SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (B), the sponsor or his/her contract research organization (CRO) is responsible for ensuring his/her principal investigators (PIs) obtain ethics committee (EC) approval, and then submitting a clinical trial application to Peru's National Institute of Health (Instituto Nacional de Salud (INS)) to obtain authorization to conduct a clinical trial.

As delineated in the INS CTManual, and Additional Resource (B), to complete the clinical trial application package, the sponsor or his/her CRO must submit a request for clinical trial authorization electronically using the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time, a registration code is assigned to the application. As per Additional Resource (B), one printed copy of the application must be submitted to the INS in an arch lever file (spring file folder) with the documents paginated and labeled using dividers, and ordered as indicated in the requirements listed in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (B), and (C). In addition to the completed application, the sponsor or the CRO must also provide the EC approval letter, clinical protocol, the Investigator’s Brochure (IB), the informed consent form (ICF), and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.
 
The application and related materials must be sent to the INS within seven (7) days of receiving the registration code. If the seven (7) day timeframe is exceeded, the application will be discarded, and another application must be submitted electronically to obtain a new registration code and initiate the process again.
 
Additionally, DecreeNo 021-2017-SA states that the sponsor must inform the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) when the first research participant is enrolled in Peru as well as the date of termination of the enrollment in the country.
 
ADDITIONAL RESOURCES
(A) (Website) Background on Clinical Trials Regulation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru
 
(B) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Requirement 1
 
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 40 and 67
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Section 3.1), Annex 1, and Annex 17
 
Sponsorship > Insurance
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SUMMARY
Overview
As set forth in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (B), it is a legal requirement for the sponsor or his/her contract research organization (CRO) to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants.
 
DecreeNo 021-2017-SA also specifies that the sponsor or his/her CRO must obtain insurance coverage in Peru, or have a legal representative in Peru who will represent the sponsor or his/her CRO if the policy is from a foreign company. The insurance policy must be in force until the date of submission of the National Final Report. And at the end of this period, it should be renewed whenever there is still a possibility of late damages arising from the adjudication of injuries resulting from the clinical trial.

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.
 
ADDITIONAL RESOURCES
(A) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Requirement 1
 
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Articles 2 and 28
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Section 3.1), Annex 1, Annex 2, Annex 5, and Annex 9
 
Sponsorship > Compensation
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SUMMARY
Overview
As specified in DecreeNo 021-2017-SA, the INS CTManual, and Additional Resources (A) and (B), the sponsor or his/her contract research organization (CRO) is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. DecreeNo 021-2017-SA also specifies that the sponsor or his/her CRO must obtain insurance coverage in Peru or have a legal representative in Peru who will represent the sponsor or his/her CRO if the policy is from another country. In addition, the sponsor or his/her CRO must submit a sworn statement guaranteeing the budget to cover possible injuries resulting from participation in the trial (see Annex 11 of DecreeNo 021-2017-SA,and Annex 9 of the INS CTManual and Additional Resource (A)).
 
DecreeNo 021-2017-SA states that the sponsor or his/her CRO must also ensure a financial fund is immediately and conveniently available that guarantees free medical treatment to participants who suffer any trial-related injuries, as long as the insurance policy is activated, and he/she must sign a statement to that effect.
 
Also, Annex 4 of the DecreeNo 021-2017-SA provides informed consent format guidelines that require the following points be included on the form:
  •  commitment to provide the research participant with up-to-date information on the investigational product (IP) or procedure, even though this may affect the participant’s willingness to continue participating in the study
  • A statement that free treatment and procedures are part of the trial
  • Economic compensation for additional expenses (transport, accommodation, communication, and food) should be provided with a specific amount listed
DecreeNo 021-2017-SA further states that participants must be ensured free access to the IP following the trial’s conclusion. Before the study commences, post-study access should be anticipated, and this information must be provided during the informed consent process.
 
In addition, as noted in DecreeNo 021-2017-SA, compensation will be awarded in the following circumstances:
  • Any damage to the research participant as a result of his participation in the clinical trial
  • Any damage that occurred during pregnancy or that would have occurred to the newborn in the case of pregnancy in a female research participant or in the couple of the male research participant, as long as it is a result of their participation in the trial
  • Economic damages derived directly from earlier stated damages provided that the damage is not inherent to the pathology under study, or, to the individual evolution of the research participant
The sponsor’s obligation to award compensation is independent of the validity or available coverage of the contracted insurance.

(See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights).
 
ADDITIONAL RESOURCES
(A) (Website) Information for Investigators (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section: Requirement 1
 
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 27-29, 40, 115 - 118, and Annex 4
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Section 3.1), Annex 1, Annex 2, Annex 5, and Annex 9
 
Sponsorship > Quality, Data & Records Management
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SUMMARY
Overview
As stated in DecreeNo 021-2017-SA, the sponsor is responsible for ensuring that all information on the investigational product and additional documentation corresponds to the research protocol and complies with good clinical practices, as well as the requirements established in DecreeNo 021-2017-SA.
 
DecreeNo 021-2017-SA also states that the sponsor is responsible for obtaining agreement from the investigators to ensure that they will allow monitoring, audits, ethics committee (EC) monitoring, and trial inspections by the National Institute of Health (Instituto Nacional de Salud (INS’s)) General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)).

Electronic Data Processing System
No relevant regulatory provisions
 
Record Management
As set forth in DecreeNo 021-2017-SA, the sponsor is required to possess a documented record of the monitoring that is being done in the trial(s), including, the provision of specially selected and specialized personnel (monitors). Additionally, the sponsor is responsible for filing in the country all documentation and data obtained for at least 10 years after the conclusion of the study. After two (2) years, the documentation/data may be filed electronically, after communication with the INS.
 
Audit Requirements
As part of the clinical protocol requirements, DecreeNo 021-2017-SA notes that the following data collection and monitoring activities should be implemented:
  • Plans to evaluate and collect baseline, outcome, and other study data, including a process to improve data quality and description of instruments used in the study along with their reliability and validity, if known
  • Plans to promote participant retention and complete follow-up, including a list of data to be collected from participants who leave the trial or deviate from it
  • Details about the data monitoring committee composition including a summary of its role and notification procedure, statement of its independence from the sponsor and its conflicts of interest; details about by-laws not included in the protocol should also be specified. Alternatively, explain why this committee is not needed
  • Description of trial monitoring arrangements/audits and sponsor’s statement to ensure that investigators will allow monitoring, audits, EC monitoring, and INS’s OGITT trial inspections, including direct access to clinical trial documentation
  • Plans to enter, encode, protect and save data, including any process to improve its quality
  • Specify where data management procedure details that are not included in the protocol can be found
 No specific timeframe is provided for the audit process.

Premature Study Termination/Suspension
DecreeNo 021-2017-SA, states that the sponsor or his/her contract research organization (CRO) is responsible for submitting the required documentation to Peru's INS to request a trial’s suspension. The request must include a report providing the reasons for the suspension, including all the data up to the time of the suspension, measures to be taken to protect the research participants, and a copy of the letter from the EC that approved the study acknowledging that it has been notified.
 
Multicenter Studies
Per DecreeNo 021-2017-SA, multicenter clinical trials require a coordinator to be appointed who is responsible for processing all of the data and analyzing the results.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 2, 40, 83, and Annex 1
 
Sponsorship > Site/Investigator Selection
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SUMMARY
Overview
As set forth in DecreeNo 021-2017-SA, the INS CTManual, the sponsor or his/her contract research organization (CRO) is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. As delineated in DecreeNo 021-2017-SA, and the INS CTManual, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor or his/her CRO should provide the investigator(s) with the protocol and an investigator’s brochure, and ensure that they agree to comply with good clinical practices and ethics standards.
 
Further, per DecreeNo 021-2017-SA, research centers must register with the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)) and uphold the following minimum requirements:
  • Research centers without hospitalization are not required to have a hospitalization area, however, a health institution nearby that can admit patients must be in place
  • The clinical laboratory must comply with duly certified or accredited quality standards and good laboratory practices. Research institutions that do not have a clinical laboratory within their facilities will be able to count on the external support of this service. In the case of national clinical laboratories, they must also be registered in RENIPRESS. REINPRESS refers to the National Registration Application of IPRESS, RENIPRESS is a platform that contains information regarding the infrastructure, equipment, human resources, and organization for the attention of the public, private and mixed IPRESS, authorized to provide health services.
A preliminary version of the affidavit is available in Additional Resource (F). Per DecreeNo 021-2017-SA, multicenter clinical trials require a coordinator to be appointed who is responsible for processing all of the data and analyzing the results.
 
Foreign Sponsor Responsibilities
DecreeNo 021-2017-SA states that if the sponsor is not based in Peru, it is a statutory requirement for the sponsor to appoint a legal representative in the country for the trial’s duration. As specified in DecreeNo 021-2017-SA, the sponsor may transfer any or all of his/her study related duties and functions to a CRO. However, he/she is ultimately responsible for the execution of the research protocol and results of the clinical trial.

Data Safety Monitoring Board (DSMB)
DecreeNo 021-2017-SA requires the sponsor to provide data on the Data Safety Monitoring Board (DSMB) including its composition, a summary of its role and notification procedure, a statement of independence from the sponsor and any conflicts of interest. Additionally, the sponsor should specify where to find other details about the by-laws not included in the protocol, or, explain why a DSMB is not necessary.
 
ADDITIONAL RESOURCES
(A) (Website) Norms (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(B) (Website) Requirements for Project Evaluation (Spanish) (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(C) (Website) Registration of Institutional Research Ethics Committee (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(D) (Website) REPEC - Sponsor, CRO, Trial Site and Ethics Committee (Current as of October 4, 2017)
National Institute of Health, Ministry of Health
 
(E) (Website) RENIPRESS (Spanish) (Current as of October 4, 2017)
Ministry of Health
 
 
National Institute of Health, Ministry of Health
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 40-42, 53-57, 108, and Annexes 3 and 4
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Sections 3.1 and 3.2) and Annex 17
 
Informed Consent > Documentation Requirements
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SUMMARY
Overview
In all Peruvian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in DecreeNo 021-2017-SA. The informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) and provided to Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

Per DecreeNo 021-2017-SA, investigator(s) must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The ICF content should be briefly and clearly presented in writing, in a manner that is easy to understand, commensurate with the comprehension level of the research participants, and without coercion or unduly influencing a potential participant to enroll in the clinical trial. When drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education. The participant and his/her legal representative(s) or guardian(s) should also be given adequate time to consider whether to participate.
 
Re-Consent
The participant and/or his/her legal representative(s) or guardian(s) is required to sign a revised ICF if any changes occur in the protocol or in the treatment methods or procedures.

Language Requirements
The ICF must be written in Spanish and in the language of the research participant.

Documentation Copies
The participant and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must sign and date the ICF. Where the participant is illiterate and/or his/her legal representative(s) or guardian(s) is illiterate, his/her fingerprint will serve as a signature, and should be obtained in the presence of and countersigned by an impartial witness who does not belong to the research team. Before participating in the study, the participant should receive a copy of the signed and dated ICF.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 2, 11, 32, 33, 34, and Annex 4
 
Informed Consent > Required Elements
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SUMMARY
Overview
As delineated in DecreeNo 021-2017-SA, prior to beginning a clinical trial, the sponsor or his/her contract research organization (CRO) is required to obtain ethics committee (EC) approval from an institutional EC for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

No Coercion
DecreeNo 021-2017-SA states none of the information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements
Per DecreeNo 021-2017-SA, the ICF should include the following statements or descriptions, as applicable:
  • The study purpose, the procedures, and duration of the trial
  • The approximate number of participants in the study
  • Any expected risks or discomforts to the participant
  • Any expected benefits to the participant
  • Treatments available to participants and how they are administered
  • Compensation and free treatment available for the participant, or family or relatives that he / she is in charge of in the case of trial-related injury or death
  • Free access to the investigational product following trial’s conclusion
  • The disclosure of specific appropriate alternative procedures or therapies available to the participant
  • Procedures for recruitment and randomization
  • The extent to which confidentiality of records identifying the participant will be maintained and who may have access to these records
  • That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
  • Contact information for the sponsor and investigator in the event of participant problems or trial-related injuries
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • The consequences of a participant’s decision to withdraw from the research and procedures for orderly withdrawal by the participant
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Populations subtopic for further information.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Section:  Articles 32, 34, 40, 67, 115-118, and Annex 4
 
Informed Consent > Compensation Disclosure
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SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, the informed consent form (ICF) should contain a statement describing the compensation and medical treatment a participant can receive for participating in a clinical trial.

Compensation for Participation in Research
Trial participants should be compensated for travel, accommodations, supplies purchased, and other expenses incurred while participating in the trial. The ICF must also explicitly state what expenses will be covered and the amount of compensation as a result of participation.
 
DecreeNo 021-2017-SA also states that participants must be ensured free access to the investigational product following the trial’s conclusion. Before the study commences, post-study access should be anticipated, and this information must be provided during the informed consent process.

Compensation for Injury
The ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 34, 35, 40, 115-118, and Annex 4
 
Informed Consent > Participant Rights
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SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, Peru’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.
 
The Right to Participate, Abstain, or Withdraw
The participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.
The Right to Information
A potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.
 
The Right to Privacy and Confidentiality
All participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. The ICF must also incorporate the following items related to privacy:
  • Data the participant will have access to and what information will be collected
  • How collected data will be used, stored and protected, and who will have access
  • That representatives of the sponsor, ethics committee (EC) and the National Institute of Health (Instituto Nacional de Salud (INS)) will have access to the data
  • How biological data and samples are handled if consent is withdrawn
  • That participants’ data will be de-identified in the case of publications and presentations of the clinical trial results
The Right of Inquiry/Appeal
The research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of his/her rights.
 
The ICF must guarantee that the participant will receive answers to any questions and clarification to any doubt about the procedures, risks, benefits and other matters related to the clinical trial and the treatment of the participant. There must also be a commitment to provide up-to-date information about the product or procedure under investigation when the participant requests it.
 
The Right to Safety and Welfare
The research participant’s dignity, safety, and welfare must be guaranteed while ensuring the quality of the research process in developing new products.
 
See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 4, 9, 34, and 40, and Annex 4
 
Informed Consent > Special Circumstances/Emergencies
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Vulnerable Populations
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SUMMARY
Overview
As per DecreeNo 021-2017-SA, in all Peruvian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerable populations are those who are relatively (or absolutely) incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes. This may include those in subordinate groups, indigenous or native peoples, and those who cannot give their consent.

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these vulnerable populations. Information on the other vulnerable populations specified in DecreeNo 021-2017-SA is provided below.

Persons in Subordinate or Dependent Groups
Clinical trials involving participants who are involved in subordinate or dependent relationships must meet the following requirements:
  • One or more of the EC’s members must represent the population under study or work with someone who has expertise in addressing social, cultural, and other issues related to the group in question
  • A participant’s refusal or withdrawal of consent during the trial should not affect his/her performance review or result in any negative consequences to the participant
These relationships include participants who are in junior or subordinate positions in hierarchically structured groups, such as students and teachers, employees and their supervisors, and soldiers and their superiors in military settings.

Research Involving Indigenous Communities
Clinical trials involving participants from indigenous communities may only be conducted under the following conditions:
  • When the expected benefit is reasonably assured; that is, when the product or knowledge generated by research is available or applied for the benefit of the community
  • The principal investigator (PI) has the approval to conduct the trial from the regional health authority and other authorities in the community, in addition to obtaining informed consent from individuals who are included in the trial
  • Sponsors and investigators develop culturally appropriate ways through working with anthropologists, sociologists, and translators to communicate the necessary information, and to meet the standards required in the informed consent process. In addition, the research protocol must describe and justify the methods the investigators plan to use to communicate information to research participants
  • Investigators agree to discontinue using individual participants when the community does not have the capacity to understand the implications of the participants’ involvement in the trial, despite the use of a translator or interpreter
  • In the case of including biological storage samples, it must have the authorization of the corresponding regional and local government, and of the respective community authorities, who must consider the interest of the community involved
Research Involving Participants with Physical Disabilities
In clinical trials involving participants with physical disabilities that prevent them from signing the informed consent form (ICF), but with the mental capacity to provide their consent, their legal representative(s) may grant his/her written consent by printing his/her fingerprint, in the presence of at least one witness, designated by the participant and who does not belong to the research team, who in turn, will sign the ICF. If the participant is unable to sign or provide a fingerprint, another means may be used that the participant approves. In this case, his/her legal representative(s) are required to sign the ICF with a witness present who is not a member of the research team. Consent may also be withdrawn by the participant and/or his/her legal representative(s) at any time without negative consequences as long as the withdrawal does not jeopardize the participant’s health.
 
Additionally, in the case of participants who, due to disabilities, are unable to give their informed consent and have not given consent prior to the onset of their disability, the following provisions must be met:
  • The informed consent must comply with the requirements delineated in the Informed Consent topic, Required Elements subtopic
  • The protocol must be approved by an ethics committee that has experts in the disease under study, or, has consulted on the clinical, ethical and psycho-social aspects in the area of the disease and the group of patients affected

 

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 2, 19, 24,25, 33 and 38
 
Informed Consent > Children/Minors
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
Although DecreeNo 021-2017-SA does not specifically state that 18 years of age is the age of majority, this point may be inferred from the definition of assent provided in the regulation. Specifically, “assent” is defined as the process by which the authorization or permission to participate in the study is obtained in documented form from the child or adolescent under 18 years.Further, DecreeNo 021-2017-SA notes that it is generally considered that children aged 8 to adolescents under 18 years of age are capable of understanding the explanation of the research and can give their assent.
 
DecreeNo 021-2017-SA states that a minor must give his/her assent, when capable of understanding the explanation of the research,  as a research participant in addition to the consent of both parents or his/her legal representative(s) and/or guardian(s). The consent of the legal representative(s) or guardian(s) may only be dismissed in the case of death, loss of rights according to Decree requirements, or, proven impossibility to obtain consent has been appropriately documented. In the event that one parent is a minor, the consent of the direct ascendant relative is also required unless the parent is a minor of 16 years of age or more; the participant has gotten married; or has obtained an official professional or trade title as established in the Civil Code. The assent of a pediatric participant from the age of 8 and under 18 years of age must be obtained to participate in an investigation.
 
All pediatric participants should be fully informed about the trial and its risks and benefits in a language and terms that they are easily able to understand. The investigator(s) must also accept the withdrawal of informed consent at the request of the child’s legal representative(s) or guardian(s) at any time, provided that the child’s health will not be jeopardized. A minor who is a teenager must also be excluded from a trial when a conflict of views exists between the legal representative(s) or guardian(s) and the teenager. A minor who reaches the age of majority during a trial must provide consent before he/she can continue to participate in the study.

In addition, the protocol must also be approved by an ethics committee (EC) that has a specialist in pediatrics or has obtained advice on the clinical, ethical, and psycho-social aspects of the trial from a pediatric expert, if applicable.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 2, 18,33 and 36)
 
Informed Consent > Pregnant Women, Fetuses & Neonates
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
As per DecreeNo 021-2017-SA, studies involving women of childbearing age or who are pregnant require additional safeguards to ensure that the research assesses the risks and benefits as well as any potential impact on fertility, pregnancy, the embryo or fetus, labor, lactation, and the newborn.

Clinical trials may only be conducted under the following conditions:
  • The informed consent of the woman and her spouse or partner is obtained, and they are given information about any potential risks to the embryo, fetus, or newborn prior to the trial
  • The spouse’s or partner’s consent may only be dismissed in the case of death; their inability to provide reliable consent; loss of rights; or, when there is imminent risk to the health or life of the woman or the embryo, fetus, or newborn
  • Informed consent may be withdrawn by the woman or spouse’s or partner’s request at any time, without detriment to them, provided the woman or fetus is not endangered
  • The research must be preceded by trials in non-pregnant women to demonstrate their safety, except for specific tests that require pregnant participants
  • The research must be aimed at improving the health of pregnant women and represent only a minimal risk to the embryo or fetus and the participant
  • During the study, investigators will not have the authority to decide on the timing, method, or procedure used to terminate the pregnancy, or to participate in decisions about the viability of the fetus
  • Informed consent for pregnant teenagers complies with the requirements stated in the Informed Consent topic, Children/Minors subtopic
Clinical trials may only be carried out in women in labor, postpartum, or breastfeeding when the following conditions are met:
  • Consent must be obtained before labor starts
  • Research will be authorized in postpartum women and breastfeeding only when there is minimal risk to the infant
  • Informed consent may be withdrawn at the participant’s or spouse’s or partner’s request at any time, without detriment to them, provided they do not affect or endanger the mother or the fetus or infant
See Title III, Chapter II (Article 23) of DecreeNo 021-2017-SA,for additional details on embryos, fetuses, and newborns.

Research Involving Men and Women with Reproductive Capacity
Clinical trials involving men and women with reproductive capacity are only permitted under the following conditions:
  • For women, the principal investigator (PI) must conduct a pregnancy test to rule out any pregnancies, and to secure commitment from the women to use effective contraceptive methods. The sponsor will provide free access and a list of contraceptive methods to the participant(s) to be selected by the participant(s) and consistent with the trial
  • In the event of pregnancy during the study, the protocol should establish the exclusion of the mother; the application of procedures to monitor and control the pregnancy as well as monitoring and control of the newborn until at least six (6) months of age to identify any effects related to the investigational product
  • For men, the PI must secure a commitment from the men to prevent conception, and to use effective contraceptive methods to be provided free of charge to the participant(s) by the PI/sponsor, as specified in the protocol and the informed consent form
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 20-23 and Annex 4
 
Informed Consent > Prisoners
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Mentally Impaired
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SUMMARY
Overview
According to DecreeNo 021-2017-SA, the following conditions must be met for clinical trials involving participants who are mentally incapable of giving consent:
  • Informed consent must be obtained from the legal representative(s) or guardian(s) who have been informed of the possible risks, discomforts, and benefits of the trial
  • Obtain informed consent from the participant when he/she has been fully informed about the trial in easily understandable language
  • Consent may be withdrawn at any time without harm to the participant and/or his/her legal representative(s) or guardian(s)

 

 

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Article 37
 
Investigational Products > Definition of Investigational Product
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SUMMARY
Overview
As delineated in DecreeNo 021-2017-SA and the INS CTManual, an investigational product (IP) is defined as a pharmaceutical form of an active substance or placebo, being tested or used as an active comparator in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.
 
DecreeNo 021-2017-SA also defines placebo as a product with a pharmaceutical form, with no active ingredient, and therefore devoid of specific pharmacological action, which may be used as a control in the clinical trial or for the purpose of maintaining blinding.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Article 2
 
(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Section: Annex 20
 
Investigational Products > Manufacturing & Import
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
According to DecreeNo 021-2017-SA and DecreeNo 016-2011-SA, the sponsor or his/her contract research organization (CRO) must obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) (ANM) to manufacture or import investigational products (IPs) in Peru. (Note: The ANM is also referred to as the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)). As per DecreeNo 021-2017-SA, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) must approve the clinical trial application prior to ANM’s approval of an IP. However, the INS does request ANM to assess the safety profile of the IP to be used in a clinical trial as part of its application review and approval process.

DecreeNo 021-2017-SA and DecreeNo 016-2011-SA specify that ANM will authorize the import of IPs exclusively for research involving humans when the applicant can provide information to support the product’s safety and quality according to the stage and type of research being conducted. Documentation requirements for ANM’s approval are as follows:
  • Application for authorization to import the product(s) under investigation and complementary products
  • Copy of INS clinical trial authorization approval
  • List of research products, complementary products and supplies to be used in the trial
  • Proof of payment for processing fee
The ANM will grant this authorization within three (3) business days of filing the application.
 
The ANM is also responsible for authorizing post-study access to the IP by study participants when it is demonstrated to be beneficial.
 
See Clinical Trial Lifecycle topic, Timeline of Review subtopic for additional information on ANM’s role in the clinical trial application approval process.
 
ADDITIONAL RESOURCES
(A) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of October 4, 2017)
Ministry of Health
 
World Health Organization
 
Relevant Section: Annex 3 (b): Certificate of Pharmaceutical Product(s)
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 8, 69, 70, 90, 94, 97, and 115-118
 
(2) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
 
Relevant Sections: Title II (Chapter I and V) and Title III (Chapter I)
 
Investigational Products > IMP/IND Quality Requirements
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, and the INS CTManual, the sponsor or his/her contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. As noted in DecreeNo 021-2017-SA, the IB must be validated and updated on a regular basis by the sponsor and at least once a year by the responsible team member (if not the sponsor), when new information on the IP—not yet included in the manual—becomes available. The updated IB should be sent to the National Institute of Health (Instituto Nacional de Salud (INS))’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)), the EC(s), and the PIs.

IB Content Requirements
As specified in DecreeNo 021-2017-SA, the IB must provide coverage of the following areas:
  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Clinical studies (pharmacokinetics, metabolism, pharmacodynamics, dose response safety, efficacy, and other pharmacological activities; safety and efficiency
  • Post-marketing experience (e.g., countries where the IP has been marketed or approved or did not receive approval/registration, was withdrawn, or registration was suspended; any significant information arising from marketed use; potential risks and adverse reactions)
  • Publication and report references
See Annex 2 of DecreeNo 021-2017-SA for detailed content guidelines.
 
As defined in the INS CTManual, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable.

As specified in DecreeNo 021-2017-SA, Peru’s INS requires the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) (ANM) to assess the safety profile of the IP to be used in a clinical trial as part of its application review and approval process. ANM’s assessment must be completed within 30 days.
 
DecreeNo 021-2017-SA states that the IP must also meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru:
 
  • Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance
  • Is produced in Peru , is used in preclinical research, and complies with Ministerio de Salud del Perú (Ministry of Health of Peru) (MINSA))’s political and/or research priorities
  • Will serve to establish pharmaceutical therapeutic equivalence
  • Is considered a priority for the country’s public health or is within the scope of MINSA policies and/or research priorities
  • At the request of the ANM require a clinical trial to support its  efficacy and safety for the health registry
Additionally, per DecreeNo 021-2017-SA, to obtain trial authorization, the following documents relating to the IP must be submitted:
  • Labeling info
  • Certificate of batch release analysis or documents that include technical specifications of the batch/series result of the finished product
  • Accelerated or long-term stability studies as appropriate
  • Current certificate of the good manufacturing practices of the IP manufacturer, issued by the competent authority of the country of origin or document that guarantees its compliance
For detailed information on documents required to be submitted for comparator IPs and complementary products, refer to Annex 5 of DecreeNo 021-2017-SA.
 
Drug Manufacturing Certificate Requirements
As stated in DecreeNo 021-2017-SA, the manufacture of IPs for their use in a clinical trial must be approved by ANM. DecreeNo 021-2017-SA also specifies that the sponsor or his/her CRO must ensure the products are manufactured in accordance with the current codes of Good Manufacturing Practice (GMP).

In addition, the sponsor or his/her CRO must complete the Listing of Products and Provisions to Use in the Clinical Trial Form (Annex 10 in the INS CTManual). This form requires the sponsor or his/her CRO to provide the following data:
  • Name of product
  • Active ingredient(s)
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Amount
  • Coding system
(See Investigational Product topic, Product Management subtopic for additional information on sponsor requirements).
 
ADDITIONAL RESOURCES
(A) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish) (Current as of October 4, 2017)
Ministry of Health of Peru
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 8, 40, 68, 69, 70, 108, and Annexes 2 and 5
 
 (2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter 3 (Section 3.1) and Annexes 1 and 6
 
Investigational Products > Labeling & Packaging
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SUMMARY
Overview
Investigational product (IP) labeling in Peru must comply with the requirements set forth in DecreeNo 021-2017-SA. IPs to be used in a clinical trial must be properly labeled in the Spanish language and printed in indelible ink.

In addition, the following information must be included as a minimum on the product label:
  • Name, address and telephone number of the sponsor or contract research organization (CRO)
  • Trial number and/or trial title
  • IP name or unique code
  • Date of IP’s expiration or reanalysis
  • Manufacturing lot number
  • Number of units and pharmaceutical form
  • Route of administration
  • Special storage and conservation requirements
  • “For research use only”, “no sale”, or similar wording indicating the IP is clinical trial material
 The inner labeling of the IP should contain:
  • IP name
  • Active ingredient concentration
  • Route of administration
  • Manufacturer's name or logo
  • Batch number and expiration date
In double-blind trials where the IP character, lot number, and manufacturer’s name is not included on the label, the package must include a document that links to information that identifies possible blinded treatments. Furthermore, the labeling must indicate the most restrictive storage requirements on both products.

(See Investigational Product topic, Product Management subtopic for additional information on investigational medicinal product (IMP) supply, storage, and handling requirements).
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Article 91
 
Investigational Products > Product Management
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, and the INS CTManual, the sponsor or his/her contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements
As described in the INS CTManual, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable. The sponsor or his/her designated CRO should not supply either party with the IP(s) until he/she obtains approval from Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) and an INS-registered ethics committee (EC). In addition, according to DecreeNo 021-2017-SA and DecreeNo 016-2011-SA, the sponsor or his/her CRO must obtain approval from the National Authority for Pharmaceutical Products, Medical Devices and Medical Products (la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) (ANM) t to manufacture or import IPs in Peru. The sponsor or his/her CRO must complete the Listing of Products and Provisions to Use in the Clinical Trial Form (Annex 10 in the INS CTManual). This form requires the sponsor or his/her CRO to provide the following data:
  • Name of product
  • Active ingredient(s)
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Amount
  • Coding system
Per DecreeNo 021-2017-SA, IPs will be dispensed through a Dispensation Unit for Clinical Trials under the Service or Pharmacy Department of the research institution where the trial will be conducted. The dispensation process must comply with the Ministerio de Salud del Perú (Ministry of Health of Peru) (MINSA))’s Good Practices of Storage and Good Dispensation Practices and study specifications the sponsor has agreed to. The Clinical Trial Dispensing unit is responsible for:
  • Maintaining a record of dates in which IP quantities are received/dispensed
  • Inventorying IPs
  • Controlling overused, used, and unused IPs for final disposal as established in the protocol
Additionally, per DecreeNo 021-2017-SA, IPs for use in trials must be funded by the sponsor and provided free of charge to research participants.
 
As per DecreeNo 021-2017-SA, the IP must also meet at least one (1) of the following conditions to be authorized for use in clinical trials in Peru:
  • Must be approved for use in humans by drug regulatory authorities of countries with high health surveillance
  • Is produced in Peru, is used in preclinical research, and complies with MINSA’s political and/or research priorities
  • Will serve to establish pharmaceutical therapeutic equivalence
  • Is considered a priority for the country’s public health or is within the scope of MINSA policies and/or research priorities
  • At the ANM’s request, require a clinical trial to support its efficacy and safety for the health registry
DecreeNo 021-2017-SA further notes that the sponsor or his/her CRO is responsible for the following IP surveillance activities:
  • Continuously evaluate IP safety and implement an IP security monitoring system
  • Notify the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) of all serious adverse events (SAEs), serious adverse drug reactions (SADRs), suspected and unexpected serious adverse reactions (SUSARs)
  • Submit SAE/SADR and SUSAR reports on international incidents to the OGITT using the Council for International Organizations of Medical Sciences (CIOMS) form occurring internationally
  • Submit IB updates to the OGITT, ECs and principal investigators (PIs)
  • Submit annual IP safety reports to the OGITT and ANM
  • Notify the OGITT, EC, and PIs of any findings that could adversely affect the research participant safety, impact the conduct of the study, or alter the benefit/risk balance. A report must be prepared for the INS and corresponding EC within a maximum period of seven (7) calendar days
  • Maintain detailed records of all adverse events communicated by the PIs
As delineated in DecreeNo 021-2017-SA, the ANM is also responsible for authorizing post-study access to the IP by study participants when it is demonstrated to be beneficial. ANM authorization is granted on a case by case basis through the following procedures:
  • Authorization of a clinical trial corresponding to an OGITT approved extension study
  • ANM authorization for an IP which must have proved to be beneficial to a participant, at the PI’s discretion, and its use will be maintained as soon as there is benefit
  • The PI should communicate to the sponsor the IP’s benefit to the participant, and the sponsor must, in turn, request ANM authorization (See Title X of DecreeNo 021-2017-SA for documentation submission requirements)
 
ADDITIONAL RESOURCES
(A) (Form) CIOMS Form I (Date Unavailable)
Council for International Organizations of Medical Sciences
 
REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 8, 89, 90, 92-94, 97), 108, 115-118, and Annex 2
 
(2) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish) (July 27, 2011)
Ministry of Health
 
Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)
 
(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (MAPRO·INS-001-V.02) (INS CTManual - Spanish) (2012)
National Institute of Health, Ministry of Health
 
Relevant Sections: Chapter III (Section 3.1), Annex 1, and Annex 6
 
 
Specimens > Definition of Specimen
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
No relevant provisions are currently available that define specimens.
 
However, as noted in DecreeNo 021-2017-SA, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Complementary Provisions Final
 
Specimens > Import & Export
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
No relevant provisions are currently available regarding the import or export of specimens.
 
However, as noted in DecreeNo 021-2017-SA, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Complementary Provisions Final
 
Specimens > Consent for Specimens
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Last content review/update: October 06, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with DecreeNo 021-2017-SA, if a clinical trial team is considering the collection and storage of biological samples for future use, this point should be explicitly delineated in a separate informed consent form (ICF).
 
Annex 4 of DecreeNo 021-2017-SA also states that the ICF must list the following biological sample study procedures:
  • Sample collection details: type, quantity and number of times to be extracted; explaining how many times and how much is needed, in measures that the research participant understands
  • Final destination of remaining samples: stating explicitly that the samples obtained will be used only for ongoing research, and will be destroyed when the trial is completed, unless storage is contemplated for future use
  • Sample storage or their remainders for future studies: if stock samples are to be stored beyond the end of the trial and/or biological samples are to be taken for storage and future studies, it should be incorporated into a specific informed consent form for that end
In addition, Annex 4 of DecreeNo 021-2017-SA also states that in the event a research participant withdraws his/her informed consent, the ICF must explain how the participant’s rights to privacy and confidentiality in the handling of his/her biological data and samples will be upheld.
 
Further, as set forth in DecreeNo 021-2017-SA, when a clinical trial is to be conducted in indigenous peoples in Peru and the storage of biological samples is being considered, authorization must be obtained from the corresponding regional and local government, and of the respective community authorities, who must consider the interest of the community involved.
 
As noted in DecreeNo 021-2017-SA, standards relating to biological samples to be used in clinical trials will be approved in a forthcoming National Institute of Health (Instituto Nacional de Salud (INS)) resolution.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Regulation) Supreme Decree No. 021-2017-SA: Approved Clinical Trials Regulation (DecreeNo 021-2017-SA - Spanish) (June 30, 2017)
National Institute of Health, Ministry of Health
 
Relevant Sections: Articles 25 34, Annex 4, and Complementary Provisions Final
 
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Expiration Date: 2/28/2019