SAHPRA Guidelines on Additional/ Change of Investigator & Site Applications + Procedure for Con


APPLICATION FOR ADDITIONAL INVESTIGATOR(S) OR CHANGE OF INVESTIGATOR(S) AND APPLICATION FOR ADDITIONAL SITES DOCUMENT

Released October 2019

NB: Incomplete documentation or sub-standard submissions will be rejected.

Application should be ring-bound. Lever arch files will not be accepted.

PROCEDURE FOR CONSULTATION MEETINGS WITH CLINICAL TRIAL APPLICANTS

Released November 2019.

This document has been prepared to serve as a guideline for applicants who wish to request a meeting with South African Health

Products Regulatory Authority (SAHPRA). SAHPRA reserves the right to request any additional information to be furnished to

establish whether such meeting may be relevant as it is reliant upon a small group of highly specialised experts.

Guidelines and application forms are available from the office of the Chief Executive Officer and the SAHPRA website.

© 2020 by SACRA. Proudly created with Wix.com

GET MORE FROM SACRA

  • White LinkedIn Icon
  • Facebook Clean
  • Twitter Clean