Subsequent Submissions

Managing Your Approved Research Study

Approval from the FPD Research Ethics Committee is an ongoing responsibility. Researchers must keep the Committee informed of changes to an approved study, request extensions where necessary, and report relevant deviations and serious adverse events in accordance with the Committee's requirements.

Select the relevant submission type below to review the documentation required.

Types of Subsequent Submissions

Each submission type has its own supporting documents and reporting requirements.

Application for Approval of Amendments

Researchers must submit an amendment application when requesting approval for changes to a previously approved study.

Required documentation:

A cover letter from the Principal Investigator (PI) explaining how the original approved documents have been changed.
The rationale for making the proposed changes.
The completed Amendments Request Form.
Applicable amended study documents, such as the study protocol, informed consent form or data collection tools.

Important: All additions and changes made to previously approved documents must be highlighted in yellow.

Application for Annual Renewal

Researchers must apply for an annual renewal when an approved study requires more than one year to complete.

Required documentation:

A cover letter from the Principal Investigator explaining why the study is taking longer than one year.
A justification for why the requested study extension should be approved.
The completed Progress Report Form.

Important: All additions and changes made to previously approved documents must be highlighted in yellow.

Protocol Deviations & Serious Adverse Events

The Principal Investigator is responsible for notifying the FPD REC Secretariat when a protocol deviation and/or serious adverse event occurs.

Reporting requirements:

Submit the required notification and supporting documentation to the FPD REC Secretariat.
Report a protocol deviation and/or serious adverse event within 24 hours after becoming aware of it.
Use the relevant Protocol Deviation and/or Serious Adverse Event reporting form.

Important: The FPD REC Secretariat must be notified electronically via email.

Submit Your Documents Electronically

Amendment requests, annual renewal documents and protocol deviation or serious adverse event notifications must be submitted electronically to the FPD REC Secretariat. Contact the Secretariat if you are unsure which documents are required for your submission.

Submission Documents

Access the available forms and supporting documents for subsequent research ethics submissions.

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Amendments Request Form

Form for requesting approval of changes to an already-approved research study.

Download document

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Study Report Form

Includes the six-month progress report and final study report sections.

Download PDF

Please confirm with the FPD REC Secretariat if you require a form or document that is not available above.

Contact the FPD REC Secretariat

For questions about subsequent submissions, required documentation or the research ethics process, please contact the FPD Research Ethics Committee Secretariat.

Secretariat: Mrs L Van Wyngaardt Telephone: 087 821 1109 Email: liviav@foundation.co.za

FPD Knowledge Park, 173 Mary Road, The Willows, Pretoria

Email the Secretariat