Updates to SAHPRA guidelines

SAHPRA is in the process of reviewing the current guidelines and forms, and in addition the numbering of the guidelines and forms were amended. This has resulted in most forms being updated (majority of the changes being administrative).

SACRA would like to remind the members to continuously review the website for latest updates https://www.sahpra.org.za/clinical-trials/

Guidelines Updated:

L-CEM-CT-07	Post Clinical Trial Access	Guideline	2022 Aug
SAHPGL-CEM-CT-06	Procedure for Consultation Meetings with Clinical Trial Applicants	Guideline	2022 Aug
SAHPGL-CEM-CT-05	Liability Insurance for Clinical Trials	Guideline	2022 Aug
SAHPGL-CEM-CT-04	Oversight and Monitoring in Clinical Trials	Guideline	2022 Aug
SAHPGL-CEM-CT-03	Emergency Procedures for Clinical Trial Sites	Guideline	2022 Aug
SAHPGL-CEM-CT-01	Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)	Communication to industry, Guideline	2022 Sep

Forms updated Sept 2022:

GLF-CEM-CT-01C (CTF2)	Application for a Protocol Amendment to an Approved Trial	Application forms, Form	2022 Sept
GLF-CEM-CT-01D (CTF3)	Application for Additional Investigator(S) or Change of Investigator(S)/Sites and Application for Additional Sites	Application forms, Form	2022 Sept
GLF-CEM-CT-01E	Notification Studies: Phase IV	Application forms, Form	2022 Sept
GLF-CEM-CT-01F	2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials	Form, Report forms	2022 Sept