Monitoring

  • After JPEC has issued ethical approval for a trial to begin, it continues to monitor the trial to ensure that the subjects’ welfare, safety and rights are protected through the dynamics of time. This is done by receiving notification from investigators of the following:
    • Amendments to the trial
    • Reports – serious adverse event, trial progress and closure reports
    • Or by conducting an audit of the trial

 

  • A Research Project Progress Report is to be submitted to JPEC at specified intervals (usually annually) once a trial is ongoing. Upon study closure, a Research Project Closure Report is to be submitted to JPEC. Normally, the first research project progress report is due one year from the date of issue of the JPEC Decision Notification Form. However, studies with higher risk to subjects may require more frequent progress reporting. The Research Progress report is not applicable to short studies, which are closed within a year from date of issue of the Decision Notification Form. In this instance, only the study closure report needs to be submitted o JPEC.

 

  • Investigator(s) involved in ongoing trial(s) are required to submit to JPEC their most recent, updated Curriculum Vitae and Annual Practicing Certificate annually (beginning of each year) until JPEC is notified of study or site closure.