You should usually commence your study within 12 months of HDEC approval. HDEC approval is automatically cancelled where a study has not commenced within 24 months.
Procedural rules around amendments and other post-approval items are contained in sections 11 and 12 of the Standard Operating Procedures for HDECs. These require researchers to:
- obtain HDEC approval for all substantial amendments
- submit annual progress reports
- inform the HDEC of substantial protocol deviations or violations
- notify the HDEC of the study’s conclusion or early termination
- submit a final report.
Serious adverse events do not need to be individually reported to HDECs.