Peru Profile Updated in ClinRegs
March 10, 2020
The Peru profile in ClinRegs now includes the following updates:
- Regulations and revised application forms that modify clinical trial application submission requirements (See the Regulatory Authority, Ethics Committee, Clinical Trial Lifecycle and Sponsorship topics)
- Legislation that updates the National Institute of Health’s (INS)’s review and approval timeline for clinical trial applications (See the Scope of Assessment and Timeline of Review sections)
- Guidance on clinical trial inspection requirements (See the Regulatory Authority and Quality, Data & Records Management sections)
- Guidance and associated forms related to Ethics Committee (EC) review and accreditation requirements for ECs (See the Scope of Review and Authorizing Body sections)
- Legislation that protects vulnerable populations during the informed consent process (See the Informed Consent topic)
- Regulations on data protection (See the Quality, Data & Records Management, Documentation Requirements and Participant Rights sections)