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Subsequent Submissions

Application for approval of amendments

The following documents must be submitted when requesting amendments to be approved:

  1. 1. Cover letter from the Principle Investigator. The principle investigator should indicate how the original amended documents/s have been changed. The rationale for making the changes should also be included.

  2. 2. Amendments request form

  3. 3. Applicable amended study documents (e.g. study protocol, informed consent form and/or data collection tools etc.)

All additions and changes made to previously approved documents must be highlighted in yellow.
Protocol amendment requests must submitted electronically via email to the FPD REC secretariat. Please find contact details on the FPD REC Contact Us page:

Application for annual renewal

The following documents must be submitted when applying for annual renewal of an approved study:

  1. 1. Cover letter from the Principle Investigator. The PI should clearly indicate why the study is taking longer than 1 year and justify why the study extension should be approved.

  2. 2. Progress report form

All additions and changes made to previously approved documents must be highlighted in yellow.
Protocol amendment requests must submitted electronically via email to the FPD REC secretariat. Please find contact details on the FPD REC Contact Us page:

Reporting of protocol deviations, Adverse Events and Serious Adverse Events

The Principle Investigator must submit the following documents to the FPD REC Secretariat within 24 hours after noticing a protocol deviation and/or serious adverse event (SAE):

  1. 1. The Principle Investigator must submit the following documents to the FPD REC Secretariat within 24 hours after noticing a protocol deviation and/or serious adverse event (SAE):

  2. 2. Protocol Deviation and/or Serious Adverse Event form

The FPR REC Secretariat must be notified electronically via email. The contact details can be found here.