Clinical Trial

PURPOSE

The Clinical Trial Unit of the South African Health Products Regulatory Authority (SAHPRA) provides legal framework for the review of clinical trials and Bioequivalence studies for human participants and recommends approval of the conduct of clinical trials. The unit receives, processes and evaluates the applications from applicants (industry, academia and investigators) for approval to conduct the study within South Africa (SA). The unit also provide for authorization for the importation of unregistered medicine for the purpose of conducting clinical trials. Any amendments required during the conduct of the study, must be approved by SAHPRA. 

LEGISLATIVE FRAMEWORK

Medicines and Related Substance Act, Act 101 of 1965, provides for the legislative framework for access to unregistered medicines, it is enabled by Section 21 of the Act as amended: Authority may authorize sale of unregistered medicines for purpose of conducting clinical trials. 

South African Good Clinical Practice Guidelines (SA GCP) provide researchers and other interested parties with clearly articulated standards of GCP in locally conducted research that address the local realities and contexts, to ensure that clinical trials involving South African human participants are designed and conducted according to local requirements as well as according to the sound scientific and ethical standards within the accepted framework for good clinical practice.

SAPRA has developed several guidelines for researchers in order to ensure that human participants are protected and are able to derive benefits from participating in clinical trials conducted in South Africa.

PROCESSING CLINICAL TRIALS APPLICATIONS

Researchers must submit a completed application on predetermined dates and obtain proof of delivery. An application form must be accompanied by the prescribed fee.  The proof of delivery, proof of payments and cover page must be sent to SAHPRA via email.

SAHPRA NEW CLINICAL TRIALS PROCESS / PRE APPROVAL

POST APPROVAL
PROCESSING OF APPLICATION FOR PROTOCOL AMENDMENT AND ADDITIONAL SITES AND/INVESTIGATORS

 

Submit the application at SAHPRA reception

 

Obtain proof of delivery
Submit proof of delivery, cover letter, proof of payment as well as the full application to CTCAmendments@sahpra.org.za

 

Screening and allocation to Internal/external Reviewer

Response provided to Applicant – Approval or Non-approval

TURNAROUND TIME FOR RESPONSE TO A CLINICAL TRIAL APPLICATION

Clinical Trial Unit aim to process new application and issue checklist within 3 weeks of receipt. The Clinical Trial Committee recommendations would be sent within 10 weeks of submission due date. There are cases where this turnaround time might be prolonged i.e. unfamiliar investigational product which may be referred to external reviewers or other committees of SAHPRA for input.

 

The timeline to receive the response after the submission of application for additional investigators, site(s) and protocol amendment is about 6 weeks following receipt of the application. The applicants should make use of the electronic submission process.

FORMS AND GUIDELINES FOR CLINICAL TRIALS FORMS

GUIDELINES

  • SA GCP Guidelines
  • Safety Reporting During Clinical Trials
  • Emergency Procedures for Clinical Trial Sites
  • Post Clinical Trial Access
  • Capacity Building and Transformation during Clinical Trials
  • Oversight and Monitoring in Clinical Trials
  • Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model
  • Clinical Trial Investigators
  • Electronic submission of clinical trials
  • Procedure for Consultation Meetings with Clinical Trial Applicants
  • Liability Insurance for Clinical Trials
  • Clinical Trials Committee Meeting and Submission dates

FREQUENTLY ASKED QUESTIONS FOR CLINICAL TRIALS

SUBMISSION OF NEW CLINICAL TRIALS (PRE APPROVED PROCCESS)

QuestionWhat are the form needed to be filled in order to apply for a clinical trial?
AnswerThe CTF-1 must be filled. Download Here

QuestionWhen can I submit a new clinical trial?
AnswerSubmission dates are published annually on the SAHPRA website refer to Link- under Clinical Trial Committee Meeting and Submission Dates
QuestionHow much does it cost to apply for a new clinical trial?
AnswerRefer to Link for fees payable to SAHPRA
QuestionWhat are the requirements for submitting a new clinical trial?
AnswerRefer to link under Electronic submission of clinical trial documents.
QuestionWhat if I do not have the required documents to complete my submission before the closing date?
AnswerThe applicant should ensure that the documentation required for submission of a clinical trial is complete as incomplete or sub-standard applications will be rejected.
QuestionWhere do I submit a new clinical trials submission?
AnswerThese are submitted at the SAHPRA reception Building 38 CSIR (subject to change)
QuestionHow do I make sure that my hard copy application gets to the right place?
AnswerUpon receipt of application at the SAHPRA Reception an acknowledgement of receipt in the form of a stamp and signature will be issued.
QuestionWhat should an acceptable Proof of Delivery look like?
AnswerThe 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.
QuestionWhere can I deliver New clinical Trials on submission date after 12:00 on a Friday when reception is closed?
AnswerAn official communication will be posted on the SAHPRA website
QuestionWill you still accept new clinical trials if submitted after the due date?
AnswerNo clinical trials will be accepted after the submission date

REVIEW OF CLINICAL TRIALS

QuestionHow will I know if my application has been received and reviewed?
AnswerUpon review of an application SAHPRA will send an official letter
communicating the outcome and queries on a screening
checklist.
QuestionWhat is the timeline for receipt of screening checklist?
Answer15 working days after submission of the application
QuestionWhat is the timeline for response of screening checklist?
Answer7 working days after receipt of the screening review
QuestionWhere do I respond to SAHPRA recommendations?
AnswerHardcopy responses must be sent to SAHPRA reception and e-

mailed to ctcresponses@sahpra.org.za
QuestionWhat should I attach when I respond to rejection screening
outcome?
AnswerNo response is required the queries must be used as guidance to
prepare for a resubmission at the next review cycle.

CLINICAL TRIAL INVESTIGATORS / CLINICAL TRIAL FACILITIES

QuestionWhat are the requirements for being a principal investigator or co-investigator?
AnswerThe requirements for participating as an investigator are obtainable from link in the document titled Clinical Trial Investigators
QuestionWhat are the basic requirements for a clinical trial sites to deal with emergencies?
AnswerThe requirements for emergency procedures at clinical trial site are obtainable from link the document titled Emergency Procedures for Clinical trial sites.

SUBMISSION OF AN AMENDMENT APPLICATION (POST APPROVED PROCCESSES)

QuestionHow do I submit a protocol amendment or an application for additional sites/investigators?
AnswerRefer to Link under Electronic submission of clinical trial documents
QuestionWhat is expected timeline to receive the response after the submission of application for additional investigators, site and protocol amendment?
Answer6 weeks following receipt of the application.
QuestionHow do I enquire regarding the application for additional sites/investigators and protocol amendment?
AnswerThe applicant should email to:
Protocol amendments:ctcamendments@sahpra.org.za
Additional sites/Investigators:ctcinvestigators@sahpra.org.za

CONTACT DETAILS

E-mail address for New clinical trials application alert, Responses to new Clinical Trial applications and related queries: ctcresponses@sahpra.org.za

 

E-mail address for Protocol amendments, responses to amendments and related queries: ctcamendments@sahpra.org.za

 

E-mail address for Additional Investigators & Sites, responses to additional and related queries: ctcinvestigators@sahpra.org.za

 

E-mail address for Bioequivalence studies, BE amendments, responses to BE studies and related queries: ctcbeprotocols@sahpra.org.za

 

E-mail address for Notifications and related queries: ctcnotifications@sahpra.org.za

 

E-mail address for Individual Patient Serious Adverse Events and related queries: ctcsaes@sahpra.org.za

 

E-mail address for SAHPRA Guidelines, forms and related queries: CTCGuidelines@sahpra.org.za