While undertaking a research project, researchers have an obligation to both the participants and to the human research ethics committee (HREC) who approved your ethics application and research governance officers to provide reporting and monitoring.
The commencement form should be sent as soon as the study commences. Use the start date rather than the date the first participant is successfully recruited.
The annual report form is due twelve months from the date of HREC approval of the study.
The final report form is due when the study is complete. A copy of the final results and any publications should be sent as soon as they are available.
Remember that HREC approval is required for any amendments to the protocol, Patient Information Consent Forms (PICFs), advertisements, questionnaires, patient cards, etc.
Please refer to the single and multi-centre amendment checklist and forward one set of papers with a covering letter from the Principal Investigator explaining the amendment rationale and whether/how it will affect the study. Please also provide an electronic copy of all documentation.
Ensure that all documents submitted for approval contain document identifiers, version numbers, dates and page numbers.
Amended documents also need to have the changes highlighted (use the Microsoft Word Track Changes feature for this).