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.

 

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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 

 

MATERIAL TRANSFER AGREEMENT OF HUMAN BIOLOGICAL MATERIALS - NATIONAL HEALTH ACT, 2003 (ACT NO. 61 OF 2003) - GAZETTE 20 JULY 2018 NO. 41781

 

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