Thailand Profile Updated

The Thailand profile in ClinRegs has been reviewed and updated with the following information:

• Personal Data Protection Committee regulation and related guidelines from 2022 (See Personal Data Protection)
• Articles providing clarification on 2022 data protection requirements (See Personal Data Protection)
• Central Research Ethics Committee documents from 2022 related to protocol submission and webpages providing fees, standard operating procedures, and research project qualification requirements (See the Ethics Committee, Clinical Trial Lifecycle, Informed Consent, and Specimens topic areas)
• Forum for Ethical Review Committees in Thailand (FERCIT) informed consent forms and checklists from 2020 (See Submission Content, Documentation Requirements, Required Elements, and Consent for Specimen)
• Thai Food and Drug Administration guidance on preparing e-submissions (See Submission Process)
• Research related requirements from the Medical Council of Thailand’s 2006 regulation on medical profession ethics (See Scope of Review, Insurance & Compensation, and Documentation Requirements)
• Clarification of patient rights listed in the 2015 Declaration of Rights and Patient Code of Conduct (See Scope of Review, Documentation Requirements, Participant Rights, Emergencies, Children/Minors, and Mentally Impaired)
• Ethical guidelines for researchers provided in the 1998 Researcher’s Code of Ethics (See Scope of Review, Initiation, Agreements & Registration, Site/Investigator Selection, Documentation Requirements, and Participant Rights)

Sources Added During this Update:

(Decree) Royal Decree Determining the Departments and Entities for Which the Data Controller is Not Subject to the Personal Data Protection Act B.E. 2562 (No. 2) (PDPA-Exten - Thai) (English-PDPA-Exten - Google Translation) (Effective June 1, 2022)
Ministry of Public Health

(Guidance) Guidelines for Notifying the Purpose and Details of Collecting Personal Data from Personal Data Subjects according to the Personal Data Protection Act (B.E. 2562) (G-PDPNotif - Thai) (English-G-PDPNotif - Google Translation) (September 7, 2022)
Personal Data Protection Committee

(Guidance) Guidelines for Obtaining Consent from Personal Data Subjects according to the Personal Data Protection Act (B.E. 2562) (G-PDPConsent - Thai) (English-G-PDPConsent - Google Translation) (September 7, 2022)
Personal Data Protection Committee

(Guidance) Risk Assessment Guidelines and Notification of Personal Data Breaches (G-PDPBreaches - Thai) (English-G-PDPBreaches - Google Translation) (Version 1.0) (December 16, 2022)
Office of the Personal Data Protection Commission

(Regulation) Notification of the Personal Data Protection Committee on Criteria and Procedures for Reporting Personal Data Breach Incidents (B.E. 2565) (PDPC-Breach - Thai) (English-PDPC-Breach - Google Translation) (December 15, 2022)
Personal Data Protection Committee

(Regulation) Regulations of the Medical Council on Maintaining the Ethics of the Medical Profession (B.E. 2549) (MCEthics - Thai) (Effective December 1, 2006)
Medical Council of Thailand, Ministry of Public Health

(Article) License Per Invoice (THA-48 - Thai) (May-August 2014)
Chantarach, Rajitpan; Food and Drug Journal

(Article) Newest PDPA Guidelines Issued by PDPC (THA-16) (September 15, 2022)
Anuktanakul, Jutharat; Charungkit-Anant, Koonlacha; Chueabunchai, Suphakorn; Laohapairoj, Pranat; Sombatsatapornkul, Theerapat; Chandler MHM Limited

(Article) PDPA Update - Thailand’s New Legislation on Personal Data Breach Notification (THA-17) (December 22, 2022)
Paiboon, Nonnabhat; Herbert Smith Freehills

(Article) Thailand: Medical Research, Pharmacovigilance, Data Management, And Data Privacy (THA-10) (May 27, 2022)
Formichella, John and Jamallsawat, Naytiwut; Formichella & Sritawat

(Article) Thailand: Overview of Thai PDPC's Notification and Guidelines On Data Breaches (THA-15) (March 7, 2023)
Mirandah, Denise; Global Advertising Lawyers Alliance

(Document) Declaration of Rights and Code of Conduct for Patients (THA-11 - Thai) (English-THA-11 - Unofficial translation) (August 12, 2015)
Medical Council, Nursing Council, Pharmacy Council, Dental Council, Physical Therapy Council, and Medical Technology Council, and Committee on the Practice of the Art of Healing

(Document) FDA e-Submissions System Preparation Guide (THA-75 - Thai) (Date Unavailable)
Thai Food and Drug Administration

(Document) Researcher’s Code of Ethics (THA-14 - Thai) (English-THA-14 - Unofficial translation) (1998)
National Research Council of Thailand

(Document) Research Protocol Package Checklist (THA-34 - Thai) (English-THA-34 - Google Translation) (Version 4.0) (Revised July 15, 2022)
Central Research Ethics Committee, National Research Council of Thailand

(Document) Submitting Project Documents for Initial Protocol (THA-29 - Thai) (English-THA-29 - Google Translation) (May 19, 2022)
Central Research Ethics Committee, National Research Council of Thailand

(Document) Template for Initial Protocol Submission (THA-38 - Thai) (English-THA-38 - Google Translation) (July 15, 2022)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Informed Consent Forms and Checklists (THA-46 - Thai and English) (2020)
Forum for Ethical Review Committees in Thailand

(Webpage) List of Research Project Documents for Initial Submission (THA-47 - Thai) (Current as of July 25, 2023)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Medicines Regulation Division - Contact Us (THA-72 - Thai) (Current as of July 25, 2023)
Thai Food and Drug Administration

(Webpage) Online Consulting System (E-Consult) - Contact Us (THA-74 - Thai) (Last Updated April 28, 2023)
Thai Food and Drug Administration

(Webpage) Payment of Project Review Fees (THA-25 - Thai) (Current as of July 25, 2023)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Types of Projects Eligible for Consideration by CREC and the Scope of Cooperation of Partner Institutions (THA-24 - Thai) (Current as of July 25, 2023)
Central Research Ethics Committee, National Research Council of Thailand

Sources Revised During this Update:

(Article) Life Sciences Regulation in Thailand: Overview (THA-5) (May 1, 2023)
Adcock, Alan and Homhuan, Atthachai; Tilleke & Gibbins

(Article) Thailand - Data Protection Overview (THA-61) (October 2022)
Suwanprateep, Dhiraphol; OneTrust DataGuidance

(Webpage) History of CREC (THA-44) (Current as of July 25, 2023)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Standard Operating Procedures for the Conduct of the Central Research Ethics Committee and the Federal Human Research Ethics Committee Office Staff (THA-37 - Thai) (Current as of July 25, 2023)
Central Research Ethics Committee, National Research Council of Thailand

(Webpage) Health Product Vigilance Center (HPVC) (THA-30 - Thai) (Current as of July 25, 2023)
Health Product Vigilance Center (HPVC), Food and Drug Administration