Clinical Trials Committee – Serious Adverse Events

The Clinical Trials Committee (CTC) follows the policy and procedure established by its precursor, the Research Ethics Review Committee, for the submission of local and non-local serious adverse events (SAEs).

The policy complies with the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans and the ICH Harmonized Tripartite Guideline: Guideline on Good Clinical Practice. The policy also incorporates recommendations from the European Commission, US Food and Drug Administration and the Canadian Association of Research Ethics Boards (CAREB).

The following points outline the new policy and provide links to the various forms:

Local SAEs (those occurring in Alberta in protocols approved by the CTC)

  • Only send SAEs that meet the definition of an unanticipated problem (related/possibly related and unexpected);
  • Use the Local SAE Report Form;
  • The CTC will not acknowledge receipt;
  • Investigator will only be contacted if more information/action is required;
  • Report Local SAEs within 15 days of occurrence or notification of occurrence; if the SAE is life-threatening or fatal, report within 7 days of occurrence/notification of occurrence.

Non-local SAEs (those occurring outside Alberta in protocols approved by the CTC)

  • Individual isolated non-local SAEs should only be reported to the CTC if they meet the definition of an unanticipated problem and place research participants at greater risk of harm;
  • If non-local SAEs meet the unanticipated problem definition, they should be reported using the Non-Local SAE Report Form;
  • If non-local SAEs are sent to the CTC and do not meet the unanticipated problem definition, they will be returned to the investigator;
  • The CTC will not acknowledge receipt;
  • Investigator will only be contacted if more information/action is required;
  • Report non-local SAEs that meet the unanticipated problem definition within 15 days of occurrence/notification of occurrence.

Safety update reports

  • Non-local SAEs should be summarized in these reports;
  • Required to be submitted at least annually with the Annual / Final Report;
  • If submitted more frequently than annually, only submit the reports that have not been previously submitted with the Annual Renewal Form;
  • The investigator can rely on the sponsor’s assessment of AEs and SAEs;
  • The CTC will not acknowledge receipt;
  • Submit Safety Update Reports within 15 days of receipt from the Sponsor using the Safety Update Report Form.
 Please email all SAE forms to sae.clinicaltrials@hreba.ca

These new procedures are immediately in effect for all local and non-local SAE submissions. All SAEs submitted prior to September 27, 2012 will be acknowledged and processed immediately, referencing only the date of the PI’s cover letter as opposed to individually detailed SAE events. All SAEs received after September 27, 2012 will be processed according to the SAE Reporting Procedure.

As per the new policy, hard copies are no longer required. You will have the option to sign the forms either by digital or hand-written signature.

If you have any questions, please contact clinicaltrials@hreba.ca