Archive
25 Jul Guideline on completion of the veterinary medicines clinical trial application form
Posted at 13:20h
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This document has been archived....
26 Jan Guideline for Clinical Trial Investigators
Posted at 14:03h
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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....
26 Jan Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)
Posted at 14:02h
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This guideline serves as a guide to applicants on the electronic submission process for major activities performed within Clinical Trials Unit (CTU)....
26 Jan Procedure for Consultation Meetings with Clinical Trial Applicants
Posted at 14:01h
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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...
26 Jan Liability Insurance for Clinical Trials
Posted at 13:59h
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This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials ...
26 Jan Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model
Posted at 13:58h
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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...
26 Jan Guideline for Capacity Building and Transformation in Clinical Research in South Africa
Posted at 13:55h
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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
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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
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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...