Feedback from latest Meeting between Industry and SAHPRA

May 27, 2020

 

 

Good afternoon Clinical Trial and SACRA Associates, 

 

A meeting was held on the 12th May between SAHPRA and the Industry Task Group, and even if the Minutes for this meeting have not been ratified yet, we would like to give you insight and feedback into what was discussed. 

 

We specifically highlight what SACRA presented to SAHPRA in regards to providing clear direction on how Clinical Trials and Monitoring work on Site is to continue during the coming days ahead.

 

See excerpt below taken from the Minutes: Item 6.2

 

Clinical trials:  SAHPRA guidance on virtual monitoring:

 

  •       ITG asked SAHPRA for clarity on applying the COVID-19 EMA guidelines that allow for use of screen sharing and remote monitoring.

 

  •       SAHPRA indicated that the Clinical Trial guidelines allows remote based monitoring at study site and will advice on further developments.

 

  • SAHPRA will review the terminology in these Clinical Trial guidelines to align with other Regulatory Authorities and refer to these other RAs.

 

Awaiting formal communication.

 

 

Download full minutes here- please note that these have not yet been ratified.

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