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)
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