Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model

This document has been prepared to serve as a guidance to applicant/sponsors of clinical trials during the use of registered or unregistered medicines in approved clinical trials. It represents the South African Health Products Regulatory’s (SAHPRA) current thinking on participant re-imbursement 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 keeping with the knowledge which is current at the time