Archive
01 Feb Six monthly progress report form
Posted at 14:45h
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This form is to be completed six-monthly from the date of approval of the clinical trial by the South African Health Products Regulatory Authority (SAHPRA). ...
01 Feb Application for Additional Investigator(s) or Change of Investigator(s)/Sites and Application for Additional Sites
Posted at 14:42h
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This is the primary application form for applicants to use in case of an application for additional investigators or change of investigator(s)/sites and application for additional sites....
01 Feb Application for a Protocol Amendment to an Approved Trial
Posted at 14:39h
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This is the primary application form for applicants to use for the purpose of amending an already approved study protocol....
01 Feb 2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials
Posted at 14:37h
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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. ...
01 Feb Clinical Trial Application Form – Guidance in conditions of a Public Health Emergency
Posted at 14:35h
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Application to conduct a clinical trial with limited information....
01 Feb Clinical Trial Application Form
Posted at 14:32h
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This document is intended to be used for new clinical trials applications...
01 Feb Notification Studies: Phase IV
Posted at 14:30h
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This is the primary application form for applicants to use in case of an application for Phase IV applications....
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)....