Guideline for Remuneration of Volunteers in Phase 1 Clinical Trials

This document has been prepared to serve as a guideline for applicants/investigators who wish to submit the application to conduct a clinical trial, application for additional sites, and additional investigators for an approved trial.

This document has been created to guide applicants/sponsors of clinical trials during the use of registered or unregistered medicines in approved clinical trials. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on participant reimbursement during clinical trial participation and proposes a minimum compensation that can be paid. It is not intended as an exclusive approach, and SAHPRA reserves the right to request any additional information and may make amendments in accordance with the current knowledge at the time.