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 guidance to 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...
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...
This is a guideline on safety reporting during clinical trials in South Africa....
To all Applicants: Kindly note that COVID-19 Clinical Trial Applications do not follow the above predetermined submission due dates. They can be submitted to SAHPRA at any time. The last COVID-19 CTC meeting for 2022 is on the 09 December 2022 and the submission due...
