Project Completion
Project Completion
All projects must have a Project Completion Form submitted in Harmony at the time of project completion.
Project completion occurs when there is no further participant involvement at the site(s), all new data collection is complete, and the sponsor closeout activities, if applicable, have been completed.
In some cases, if the project is receiving funding there may be a requirement to keep the project active while funds are being accessed. It is also suggested that the project remain active in Harmony until after the first publication has been submitted in the event it is a sponsor requirement or journal editors request additional information requiring an amendment to the Harmony Health Research Application.
RITHIM must be notified of completion of any project previously submitted for review regardless of whether the project received final approval or not.
Multi-Centre Projects
The local project site may be considered complete if there is no further involvement of local participants even though the project continues at other sites. For industry-sponsored projects, a Project Completion Form should only be submitted in Harmony after the sponsor has conducted the close-out visit. If the sponsor has no plans to conduct a close-out visit, the Project Completion Form must be submitted after all data clarifications have been completed and the sponsor has indicated to the researcher that the project files can be archived for long term storage.
Local Single-Centre Projects
A Project Completion Form must be submitted in Harmony when all project-related activities, including long-term follow-up data are complete.
For projects that do not involve individual participants (for example, those using administrative datasets) a Project Completion Form can be submitted when data acquisition is completed.
For local registries or research databases, a Project Completion Form must only be submitted after the database is destroyed or there is no intent to access the dataset in the future for research purposes.
Early Termination or Suspension
If a project is terminated prematurely or suspended for any reason, the researcher must immediately submit the Harmony Reportable Event Form informing RITHIM of the event. The researcher must include the reasons for the suspension/early termination, the measures in place to ensure appropriate therapy and follow-up of participants; and the procedures for notifying participants.
Acknowledgement of Receipt
RITHIM will review the Project Completion Form in Harmony and send a confirmation of receipt email. Please retain it for your records.
Posting of Clinical Trial Results
To facilitate transparency of project results, RITHIM strongly encourages that all clinical trial results are posted on a publicly accessible results website within 6 to 12 months of project completion.
Record Retention
Effective February 11, 2022, Health Canada changed the clinical trial record retention period from 25 years to 15 years under the Food and Drug Regulations.
For non-clinical trials, please refer to your home institution record-keeping policies and other relevant legal or regulatory requirements.