The updated forms are listed below:
The clinical trial application form, CTF 1 form, GLF-CEM-CT-01A_v7_ June 2022 (CTF1), effective from 01 June 2022
The clinical trial application form, CTF 1 form, Guidance in conditions of a Public Health Emergency, version 2. 01 June 2022
Please see the changes below, highlighted in RED:
The CTF 1 summary of changes as below
Administrative Changes for implementation, revision to sections Checklist, 2.3, 4.8, 4.9, 4.12, 10.2 and Annexure 1 01 June 2022
Checklist: Must include
Certificate of GMP for the manufacture of the Investigational product(s)
Evidence of accreditation/Certifications of the designated laboratories
Proof of payment (Bank validated)
Section 2.3
Details of investigators and staff (Investigators, staff, number of staff, names, qualifications, experience preferably in a table and include the titles of investigators involved)
Section 4.8
Estimated Quantity of Trial Material (each medicine detailed separately) for which exemption will be required (including overage and justification for overage if above 20 %) include supplemental medical devices e.g testing kits and concomitant medicines to be imported.
Section 4.9
If any of the above medicines/medical devices are available in South Africa, give an explanation of why they need to be imported from elsewhere.
Section 4.12
Details of the manufacture, quality control and stability of the IP. Provide a certificate of GMP for the manufacture of the IP.
Section 10.2
Provide Statistical method(s) and analysis of qualitative and/or quantitative measures with appropriate, clear justification. Provide the statistical analysis plan if available
Changes to the annexure 1 of the CTF 1
Progress report changes
GLF-CEM-CT-06A_v4_Six Monthly Progress Report Form_ June 2022
Addition of sections 13, 14 and 15
Document number changed from 6.27 to GLF-CEM-CT-06A
Section 13
Provide proof of current registration on the South African National Clinical Trials Registry (SANCTR)
13.1 DoH Number
13.2 Enclose transcript reflecting current information from SANCTR
Section 14
Provide the summary of the investigational product:
Authorized for importation
Imported
Used during the Clinical Trial
Destroyed (include the destruction certificate(s)) and
Quantity to be exported or exported
14.1 Overall comment on Investigational Product Reconciliation
Section 15
The planned date for provision of trial results to SAHPRA and SANCTR (applicable to the final progress report)
Members are reminded to always refer to the SAHPRA website when competing for a new application: https://www.sahpra.org.za/clinical-trials-application-and-report-forms/