IIUM RESEARCH ETHICS COMMITTEE (IREC)

IIUM RESEARCH ETHICS COMMITTEE (IREC)

POST-APPROVAL REPORTING

POST-APPROVAL REPORTING


Investigator responsibility will continue after approval was given. Below are the essential document for reporting:

  • Progress Report - Every 6 months
  • End of Study Report - After the completion of research based on submitted document.
  • Amendment report - if there is any amendment on the approved study
  • SAE Report - for Clinical Trial Only
  • Continuing review Form - if investigator require an extension of the study period

All the report above will undergoes review as in the Initial review. Failure to submit the document on time may result in the REVOCATION of Investigator Ethical approval which may hinder the Publication of the research.

*The form can be obtained from Resources/Download