SAHPRA CTA forms and Guidelines updates.

May 26, 2020

Dear All,

 

Attached are the latest guidelines and forms for immediate implementation effective March 2020.

 

Eight Clinical Trial Application forms and Guidelines updates, effective March 2020.

 

1. APPLICATION FOR ADDITIONAL INVESTIGATOR(S) OR CHANGE OF INVESTIGATOR(S) AND APPLICATION FOR ADDITIONAL SITES: This document is intended to be used for application for additional investigator(s) or change of investigator(s) and application for additional sites

 

2. APPLICATION FOR PROTOCOL AMENDMENT TO APPROVED TRIAL: This document is intended to be used for applying for protocol amendment to approved trial.

 

3. APPLICATION TO CONDUCT A CLINICAL TRIAL: This is intended to be used for new clinical trials applications.

 

4. NOTIFICATION STUDIES: PHASE IV: This is intended for Applicants to notify the South African Health Products Regulatory Authority (SAHPRA) of intention to undertake a phase IV clinical study of an approved medication within its approved dosage, formulation and indication.

 

5. CLINICAL TRIAL INVESTIGATOR WORKLOAD FORM: This is intended for all Investigators (Principal investigators, Co-Principal investigators and sub-investigators) who would like to conduct a clinical trial in South Africa.

 

6. SAFETY REPORTING DURING CLINICAL TRIALS FORM: This is intended for all Investigators/Sponsor/Applicants conducting clinical trial in South Africa. This has been prepared to serve as a form to those reporting serious adverse events occurring during the use of registered or unregistered medicines in approved clinical trials.

 

 

7. APPLICATION TO CONDUCT A CLINICAL TRIAL WITH LIMITED INFORMATION: Guidance in conditions of a Public Health Emergency.

 

 

8. SUBMISSION REQUIREMENTS | APPLICATION TO CONDUCT A CLINICAL TRIAL: Notification to all applicants of the latest submission requirements process in the Clinical Trials Unit (CTU), South African Health Products Regulatory Authority (SAHPRA), in order to improve the internal processes in order to improve turnaround times of applications.

 

9. eCTD VALIDATION and TECHNICAL SCREENING FOR VARIATIONS: The Validation Template is used on receipt of an application to verify that all required information has beensupplied to SAHPRA in order to evaluate a variation application for a medicinal product for human use submitted in eCTD format. It is also used for follow-up sequences that may be required for the variation.

 

10. eSUBMISSION VALIDATION and TECHNICAL SCREENING FOR VARIATIONS: The Validation Template is used on receipt of an application to verify that all required information has been supplied to SAHPRA in order to evaluate a variation application for a medicinal product for human use submitted in eSubmission format. It is also used for follow-up sequences that may be required for the variation. The applicant must ensure that all relevant fields are completed.

 

 

 

 

 

 

 

 

 

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