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After approval

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.