Post-approval reporting

While undertaking a research project, researchers have an obligation to both the participants and to the Human Research Ethics Committee (HREC) and Research Governance Officers to provide reporting and monitoring.

Reporting timeframes

• HREC reporting timeframes (single)
• HREC reporting timeframes (multi-centre)

Commencement, annual and final reporting

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.

• Notification of commencement of research protocol

The ‘annual progress/final report’ form is due every twelve months on the anniversary of the HREC approval of the study and when the study is complete. A copy of the final results and any publications should be sent as soon as they are available.

• Annual/final report

Reporting adverse events

Reporting a local Serious Adverse Event is required as soon as an event is reported.

• Report of locally occurring adverse event to HREC form
• Serious adverse event report form (not occurring at local site)

Amendments

Your sponsor should direct the periodical schedule of sending the safety and SUSAR reports, e.g. 6 monthly SAE /safety/ SUSAR reporting to the relevant HREC.

• SAE/safety/SUSAR reporting

Remember that HREC approval is required for any amendments to the protocol, PICF s, advertisements, radio scripts, 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.

• Change of study personnel form
• Single and multi-centre amendment checklist

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).

Single and multi-centre amendments

• The amendment checklist details submission requirements for an application amendment.

Data archiving, retention and disposal

• The data archiving, retention and disposal guideline provides information on archiving, retention and disposal of research data.