Study Closure/Termination

Definitions
Requirements for Notification of Premature Termination or Study Closure
Submission Process
Acknowledgement of Receipt



In accordance with the Tri-Council Policy Statement, ICH Good Clinical Practice Guidelines, Health Canada regulations and University of Manitoba policies, researchers conducting studies with approval from a Bannatyne Campus Research Ethics Board (REB) are required to submit a Final Study Status Report to the REB upon closure of the study or study termination and to notify the REB when a study has been prematurely suspended.

The following guideline is intended to outline submission requirements for notifying the Research Ethics Board (REB) of study closure or when a study is prematurely suspended.

Definitions

Study Closure- The time at which data is archived at the local site or in the case of multi-centre trials when all data has been transferred to the sponsor after the close out visit.


Requirements for Notification of Premature Termination or Study Closure

The Bannatyne Campus REB office must be notified of closure of any study previously submitted for ethical review regardless of whether the study received final approval or not.

Premature Termination or Suspension of a Trial

If a study is terminated prematurely or suspended for any reason, the Principal Investigator (PI) must promptly inform the REB in writing of this suspension; the reasons for the suspension and the appropriate measures in place to assure appropriate therapy and follow-up for the participants; and the procedures considered for notifying the participants. If the reason for suspension is related to an emergent safety issue, the notification should be either faxed to the REB office or preceded by a telephone call to the Chair or REB Coordinator.

The Bannatyne Campus Final Study Status Report is also required at the time the sponsor conducts the close out visit as indicated below:

Multi-Centre Studies

The local site may close if there are no further implications to local participants even though the study continues in other sites. For industry sponsored studies, a Final Study Status Report should only be submitted to the REB office after the sponsor has conducted the close out visit. If the sponsor has no plans to conduct a close out visit, the Final Study Status Report must be submitted after all data clarifications have been completed and the sponsor has indicated to the Principal Investigator (PI) that study files can be archived for long term storage.

Local Single Centre Studies

A Final Study Status Report must be submitted to the REB office after the study when all study related activities including long term follow-up of data are completed.

For studies that do not involve direct participant participation for example, secondary use of data, a Final Study Status Report can be submitted when data acquisition is completed. NOTE:  In some cases if the study is receiving funding there may be a requirement to keep the study file open while funds are being accessed.  It also is suggested the study file  remain open during the initial data analysis for potential first publication should journal editors request additional information. This will facilitate the review of the amendment by the Research Ethics Board to collect this additional information.

For local registries or research database, a Final Study Status Report must only be submitted after the database is destroyed or there is no intent to access the dataset in the future  for research purposes.


Submission Process

Required Documentation - Final Study Status Form (pdf)

2 copies (The second  copy is required when acknowledgement of receipt is being requested) of the Bannatyne Campus Research Ethics Board Final Study Status Report.  This document must be completed for all studies regardless of whether the project is a clinical trial or not.

Scanned pdf copies of a signed Bannatyne Campus Research Ethics Board Final Study Status Report  via e-mail to insert Bannatyne e-mail address will be accepted.  NOTE: Final Study Status Reports  are the only reports accepted by e-mail at this time.


Acknowledgement of Receipt

If required by the sponsor, the REB office will acknowledge receipt of Final Study Reports or notices of premature termination or suspension provided the Bannatyne Campus Research Ethics Board Final Study Status Report is completed and submitted in duplicate to the REB office along with a self-addressed return envelope. Other documentation will not be given an acknowledgement of receipt.

The duplicate copy will be initialed and dated by the REB office staff and placed in the addressed return envelope provided for the REB.  If the Final Study Status Report was sent via e-mail retain a copy of this e-mail as the e-mail will be considered the acknowledgement.  NOTE:  In this case the REB will not send a initialed report to the site.

It should be noted, there is no regulatory requirement for acknowledgement of notices re study closure or premature termination.


MANDATORY NOTIFICATION
The Bannatyne Campus REB office must be notified of closure of any study previously submitted for ethical review regardless of whether the study received final approval or not.

The  Final Study Status Report (pdf) must be completed and submitted for review.

POSTING OF CLINICAL TRIAL RESULTS
To facilitate transparency of study results the University of Manitoba is strongly encouraging that all clinical trial study results are posted on a publicly accessible results website within 6-12 months of study completion.