Archive
01 Sep Veterinary Clinical Trial Application Template
Posted at 11:01h
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This template is intended to provide recommendations to applicants wishing to submit veterinary clinical trial applications. The template should be completed in conjunction with the attached guideline document. ...
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This document has been archived....
01 Feb Safety Reporting during Clinical Trial Form
Posted at 14:47h
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This is a form to report ADRs in clinical trials....
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....