Clinical Trials Submission of New Clinical Trials (Pre-Approved Process)
What are the forms needed to be filled in order to apply for a clinical trial?
When can I submit a new clinical trial?
Submission dates are published annually
How much does it cost to apply for a new clinical trial?
What are the Requirements for Submitting a New Clinical Trial?
What if I do not have the required documents to complete my submission before the closing date?
The applicant should ensure that the documentation required for submission of a clinical trial is complete as incomplete or sub-standard applications will be rejected.
Where do I submit a new clinical trials submission?
These are submitted at the SAHPRA reception – 2nd floor, Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0007
How do I make sure that my hard copy application gets to the right place?
Upon receipt of application at the SAHPRA Reception (2nd floor, Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0007) an acknowledgement of receipt in the form of a stamp and signature will be issued.
What should an acceptable proof of delivery look like?
The waybill from a courier company does not suffice. SAHPRA’s Clinical Trials Unit requires a document, referred to as the ‘stamp page’, which includes the SAHPRA trial reference number, protocol number and study title to reflect on it. This document will then be date-stamped and signed by our Administrative department and returned to the sender as proof.
Where can I deliver new clinical trials on submission date after 12:00 on a Friday when reception is closed?
An official communication will be posted on the SAHPRA website
Will you still accept new clinical trials if submitted after the due date?
No clinical trials will be accepted after the submission date
Review of Clinical Trials (preliminary screening)
How will I know if my application has been received and reviewed?
Upon review of an application SAHPRA will send an official letter communicating the outcome and queries on a screening checklist.
What is the timeline for receipt of screening checklist?
15 working days after submission of the application
What is the timeline for response of screening checklist?
7 working days after receipt of the screening review
Where do I respond to SAHPRA recommendations?
Hardcopy responses must be sent to SAHPRA reception and e-mailed to ctcresponses@sahpra.org.za
What should I attach when I respond to rejection screening outcome?
No response is required the queries must be used as guidance to prepare for a resubmission at the next review cycle.
Review of Clinical Trials (Expert committee review)
How often does this committee sit to discuss applications?
CTC dates are published annually on the SAHPRA website – refer to Clinical Trial Committee Meeting and Submission Dates
What are the possible outcomes of a clinical trial review?
Clinical trials reviews can be classified as follows:
- Category 1A: Approved No Items pending.
- Category 1B: Approved ethics approval pending.
- Category 2A: Not Approved. For approval by in house evaluators, 1-2 or more items outstanding as deemed by the committee.
- Category 2B: Not approved for approval by the original evaluator and in-house if a need arises.
- Category 3: Not Approved Items outstanding to be discussed at the next CTC meeting, the next cycle.
- Category 4: Not Approved for referral for specialist opinion.
- Category 5: Not approved – technical/ scientific deficiencies Applicant to resubmit for the next cycle.
- Category 6: Rejected due to administrative and technical items outstanding. Applicant to resubmit for the next cycle
What is the expected timeline for response from clinical trial committee review?
10 working days after clinical trial committee meeting
What is the timeline for submitting responses from expert committee review?
7 working days after receipt of comments
How do I arrange a meeting with the clinical trials committee / SAHPRA?
The request must be initiated through the office of the CEO. Please refer to Procedure for Consultation Meetings with Clinical Trial Applicants.
Clinical Trial Investigators / Clinical Trial Facilities
What are the requirements for being a principal investigator or co-investigator?
The requirements for participating as an investigator are obtainable from Clinical Trial Investigators
What are the basic requirements for a clinical trial site to deal with emergencies?
The requirements for emergency procedures at clinical trial site are obtainable from Emergency Procedures for Clinical trial sites.
Submission of an Amendment Application (Post-Approved Processes)
How do I submit a protocol amendment or an application site/investigators?
What is the expected to receive the response after the submission of application for additional for investigators, site and protocol amendment?
6 weeks following receipt of the application.
How do I enquire regarding the application for additional site/investigators and protocol amendment?
The applicant should email to:
- Protocol amendments:ctcamendments@sahpra.org.za
- Additional sites/Investigators:ctcinvestigators@sahpra.org.za