During the 20 November 2017 Clinical Trials Stakeholder Workshop, Dr Diale presented a number of revisions to existing clinical trial forms to the attendees. These included the application to conduct a clinical trial form (CTF1), the 6-monthly progress report form and a new standardised SAE reporting form.
The application to conduct a clinical trial (CTF1) was published on the MCC website on 18 October 2017, and was required to be used for all new applications submitted from January 2018 onwards. http://www.mccza.com/Publications/DownloadDoc/5573. The MCC also provided feedback on queries raised by industry during the stakeholder meeting, these have been published on the SACRA website http://media.wix.com/ugd/c4640f_055d52e8c52340c2857e2111630289f0.pdf.
The 6-monthly progress report form was published on the MCC website on 26 January 2018 and is effective for implementation. http://www.mccza.com/Publications/DownloadDoc/5599
The new standardized SAE reporting form, along with its companion document, the revised “Safety Reporting During Clinical Trials” guideline, had not been published on the MCC website at the time of the writing of this blog.
The South African clinical trials industry is spending significant amounts of time and energy coming to terms with the requirements included in these new forms and seeking advice on how best to complete them for their unique trial.
In order to ensure that industry are addressing the same items consistently, and to reduce the burden on the CTC and Secretariat of repeatedly answering the same questions, the South African Clinical Research Association (SACRA) would like to ask its members to please assist us by forwarding any useful information regarding completion of these forms to email@example.com. The information can be in the form of de-identified emails or CTC feedback. This information will then be collated into a Q&A document and posted on the SACRA website