Clinical Trials Committee | Closing a Study
Research Completion (Closures)
The submission of a closure indicates that all research activities have ceased, the research does not require continuing ethics approval, and the HREBA-Clinical Trials Committee (CTC) file can be closed.
Determining When a Closure is to be Submitted
For research that involves direct interaction with participants, a closure may be submitted when:
- there is no further participant involvement/interaction,
- all data collection, clarification and transfer is complete (this includes access to participants’ records that have personally identifying health information) and,
- (if applicable) the sponsor has conducted the appropriate closeout activities.
- In cases where the research is grant funded, there may be a requirement by the funder to keep the file open while the funds continue to be accessed.
- If the research is funded or supported by the US Federal Government (i.e., NIH) the file cannot be considered closed until follow-up of subjects is final and there is no further data analysis involving individually identifiable information.
- When the closure is submitted either the results should have been disseminated, or a plan is in place for their dissemination.
Submitting a Closure
If your research meets the above criteria, it can be closed.
Submit a closure by clicking the “Request Closure” button within IRISS. The study team(s) will receive a notification indicating that a closure request has been submitted. The Principal Investigator(s) (PI) will be further contacted if additional information is required. Once the closure request has been processed (i.e., reviewed and approved) the study team(s) will receive a notification confirming that the file is closed.
Once a research study is Closed with the CTC, no further submissions for that research will be permitted. However, if relevant information, such as that listed below, becomes available, it should be submitted following the method for submitting a reportable event. If applicable, further investigation and/or action may be undertaken by the Committee.
- Documentation that impacts the safety of participants previously involved with the research (e.g. dear investigator letter, change in Health Canada or FDA safety labeling, etc.)
- Privacy Breaches
- Participant Complaints
If a sponsor requests additional data following the closure of the research, a request for ethics approval must be submitted.
Last Edited: 08 Nov 2019