Clinical Trials submission to the Faculty of Health Sciences Research Ethics Committee
Notice to Researchers
The researcher should please follow the NDOH 2024 South African Ethics in Health Research Guidelines: "Since SA GCP requires prior SAHPRA approval for clinical trials, it is recommended that ethics approval should be delayed until SAHPRA scientific approval has been provided."
Please submit to us once SAHPRA approval has been obtained.
List of documents required
PROTOCOL
CV
CONSENT DOCUMENTS
Participant's Information Consent Documents (include Assent)
QUESTIONNAIRES/INTERVIEW SCHEDULES AND/OR DATA CAPTURE SHEET
Questionnaires/interview schedules and/or data capture sheet.
DECLARATION BY PRINCIPAL INVESTIGATOR AND SUB-INVESTIGATOR
GCP TRAINING CERTIFICATE
GCP Training Certificate of the Principal Investigator and Sub-Investigator.
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
Application or Written approval required from SAHPRA.
NATIONAL HEALTH RESEARCH ETHICS COUNCIL REGISTRATION NUMBER
MATERIAL TRANSFER AGREEMENT FOR HUMAN BIOLOGICAL MATERIALS
FINANCIAL CONTRACT - Copy of financial contract
INSURANCE CERTIFICATE
INVESTIGATOR’S BROCHURE
DIARY CARDS, ADVERTISEMENTS ETC (if applicable)
OTHER DOCUMENTS (if applicable)
Templates available (choose as appropriate)
Updated 4 June 2025
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