This document has been prepared to serve as a guideline to enable the direct payment of fees into the bank account of SAHPRA. It must be read together with the relevant Fees Regulations and the General Information guideline....
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 guideline serves as a guide to applicants on the electronic submission process for major activities performed within Clinical Trials Unit (CTU)....
This document has been prep ared to serve as a guideline for applicants who wish to request a meeting with South African Health Products Regulatory...
This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials ...
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...
Guideline for consultation meetings in clinical trials. This document has been prepared to serve as a guideline for preparation of applications to conduct clinical trials in South Africa....
This guideline assists sponsors of clinical investigations in developing monitoring strategies and plans for investigational studies of medical products, including human medicine and biological products, medical devices, and combinations thereof. The overarching goal is to enhance human participant protection and the quality of clinical...
This document has been prepared to serve as a guideline to sponsors/applicant and investigators providing investigational pro duct to participants during clinical trials. This...
This document highlights the importance of having emergency standard operating procedures in place during the conduct of clinical trial at sites and also includes...