CTC Ongoing Review of an Approved Study – revised January 2017

Links to information on this page regarding ongoing approved studies:

 

Amendments to the Protocol/Participant Information and Consent Form(s)

These must be submitted and include a summary indicating all changes to the protocol.  If the participant information and consent form is revised as a result of the amendment, a copy must be submitted for approval with an updated version date and the changes in a tracked changes format using Additions / Deletions.

For multi-centre studies, the HREBA – Clinical Trials Committee (CTC) would appreciate coordination of the submission of the revised documents through the lead investigator, who was first to be approved for the study.  Upon approval of the documents for that lead investigator, all participating sites will be notified of the approved documents.  The sponsor will be responsible for providing the approved version to each site.

Once the lead site documents are approved, all other participating investigators will be notified and must submit the appropriate revised documents. For REC paper files, please mail the information.  For IRISS files please open a Modification.

 

Protocol Deviations

For REC paper files, please mail the information.  For IRISS files please open a Modification.

The investigator should promptly report the following to the CTC:

  1. Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see section 4.5.2 and 4.5.4 of the GCP ICH Harmonised Tripartite Guideline below)
  2. Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see section 4.10.2 of the GCP ICH Harmonised Tripartite Guideline below).

Individual instances of failures to comply with the protocol do not constitute a protocol deviation (e.g. adverse events, administrative alterations and/or errors).

  • “4.5.2 The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)).”
  • “4.5.4 The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favourable opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted: (a) to the IRB/IEC for review and approval/favourable opinion, (b) to the sponsor for agreement and, if required, (c) to the regulatory authority(ies).”
  • “4.10.2 The investigator should promptly provide written reports to the sponsor, IRB/IEC (see 3.3.8) and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects.”

 

Serious Adverse Events

The following points outline the 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;
  • Receipt by the CTC will not be acknowledged;
  • 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 (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;
  • Receipt by CTC will not be acknowledged;
  • 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 Renewal Form;
  • 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;
  • Receipt by CTC will not be acknowledged;
  • Submit Safety Update Reports within 15 days of receipt from the Sponsor using the Safety Update Report Form.

Please email all SAE forms to Clinicaltrials@hreba.ca
Hard copies are not required. You will have the option to sign the forms either by digital or hand-written signature.

 

Annual Report

For REC paper files, a completed Annual Report must be submitted annually after approval of the protocol for review by the Committee.  A reminder letter will be sent to you one month before this report is due.

For IRISS files, a “Create a Renewal” activity button will appear in the file 30 days prior to the file expiry date. Complete the Renewal Summary Form and submit for review.  Reminder emails will be sent to you from IRISS.

 

Final Report / Closure

For REC paper files, a completed Final Report must be submitted for review upon completion or termination of the study.

For IRISS files, click the “Request Closure” button in the file. Complete the Closure Form and submit for review.