Clinical Evaluations Management Archives - Page 5 of 6

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

Posted at 13:58h in

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...

26 Jan Guideline for Capacity Building and Transformation in Clinical Research in South Africa

Posted at 13:55h in

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....

26 Jan Oversight and Monitoring in Clinical Trials

Posted at 13:54h in

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...

26 Jan Post Clinical Trial Access

Posted at 13:52h in

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...

26 Jan Emergency Procedures for Clinical Trial Sites

Posted at 13:49h in

This document highlights the importance of having emergency standard operating procedures in place during the conduct of clinical trial at sites and also includes...

26 Jan Safety Reporting During Clinical Trials

Posted at 13:45h in

This is a guideline on safety reporting during clinical trials in South Africa....

26 Jan SA Good Clinical Practice Guidelines

Posted at 13:42h in

These guidelines have the purpose of providing researchers and other interested parties with clearly articulated standards of GCP in locally conducted research that address the local realities and contexts, to ensure that clinical trials involving South African human participants are designed and conducted according to...

25 Jan Reliance Guideline

Posted at 10:33h in

This guideline is intended to provide recommendations to applicants wishing to submit new registration applications, as well as variations, for reliance review-based evaluation....

25 Jan Guideline for Professional Information for Human Medicines (Categories A and D)

Posted at 10:15h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...

25 Jan Guideline for Patient Information Leaflet for Human Medicines (Categories A D)

Posted at 10:13h in

Archive