This is the primary application form for applicants to use for the purpose of amending an already approved study protocol....
Due to the rapidly changing dynamics of the condition/disease, it has become necessary for the South African Health Products Regulatory Authority (SAHPRA) to introduce a two-weekly public health emergency (PHE) Abridged Interim Safety and Futility Monitoring Report Form for clinical trials. ...
Application to conduct a clinical trial with limited information....
This document is intended to be used for new clinical trials applications...
This is the primary application form for applicants to use in case of an application for Phase IV applications....
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....