Clinical Trials Disclosure Monitoring: Frequently Asked Questions

• Why am I receiving this compliance report?

  You are receiving this compliance report because a grant you were awarded, as a nominated principal investigator, with a funding start date on or after January 1, 2022, was identified as supporting a clinical trial.

• What if I believe I received this compliance report in error (i.e., I am not conducting a clinical trial using funds from the CIHR grant referenced in the monitoring correspondence)?

  CIHR’s definition of a clinical trial can be found in CIHR’s Glossary of Funding-Related Terms. If you believe your project does not contain a clinical trial that meets this definition, please contact the CIHR Contact Centre.

• What if my study isn’t underway yet or hasn’t been completed?

  We understand the start-up of clinical trials can take a significant amount of time and that each study will meet the defined milestones for disclosure activities at different times. Each question has space provided to justify why the elements of the policy have not yet been met. This will be monitored annually.

• When can my grant be removed from policy monitoring?

  CIHR will remove a clinical trial grant from policy monitoring when the following criteria are met, and confirmed by the Nominated Principal Investigator (NPI):

  The following 3 criteria apply to the clinical trial funded by CIHR, or in the case of a larger study, to the portion of the trial that was funded by CIHR:

  • There is no further trial activity:
    • The clinical trial is cancelled/terminated (e.g., lack of feasibility, inability to recruit, changes in study population or science that make the trial obsolete or unethical), or
    • The trial is stopped in accordance with pre-defined stopping rules for efficacy, safety or futility, or other stopping endpoint (incl. at interim analysis), or
    • The trial was completed as planned.

    AND

  • All collected trial results have been reported*,

    • All trial data that was collected (as part of the funded CT plan), and any “new information revealed during the conduct of the trial that might affect the welfare or consent of participants” (TCPS2 Chapter 11) has been reported on (results posted to the public registry or published).

      *unless the trial was cancelled/terminated without data collection, or with so few participants that confidentiality could not be ensured if reported (i.e., possible re-identification of participants, per local health-related privacy laws).

    AND

  • there are no further publications or result disseminations planned**.

    **acknowledging that future studies could have secondary use of data from the trial (exempt from monitoring), or could re-engage the trial population in a new intervention/trial, both as part of a separate trials/grant.

  If there are still trial activities being performed, or if additional result dissemination is expected based on the grant application funded by CIHR (including long-term follow-ups), CIHR will continue to monitor compliance with the Policy Guide.

  NPIs are asked to contact CIHR in the case where they believe their trial to be complete or where the policy guide no longer applies.

• I have already provided my clinical trial registration information to my Research Ethics Board (REB). Why do I need to provide it to CIHR?

  CIHR’s policy guide states that CIHR will monitor compliance with policy requirements on an annual basis, by asking impacted researchers to provide clinical trial registration identifiers, and links to summary results and open access publications. REBs do not provide this information to CIHR; disclosure to CIHR is the responsibility of the nominated principal investigator.

• How will the information I provide be used?

  Compliance report responses are kept confidential. They are used for the purposes of monitoring compliance with CIHR’s policy on the Requirements for Registration and Disclosure of Results from Clinical Trials.

  CIHR will annually publish anonymous aggregated data from all respondents indicating the overall degree of compliance with these requirements. While responses are confidential, in cases of non-response, CIHR may follow up through the nominated principal investigator’s institution.

• Will the compliance report website retain my responses?

  The compliance report website will not store data for future use once the responses are submitted. We strongly encourage respondents to retain their answers to simplify future submissions. By answering the last question of the compliance report, you can choose to have a copy of your responses sent to you by email.

• It’s noted that the compliance report link will remain available, how often do I have to submit a report?

  CIHR will monitor compliance with the policy requirements for registration and disclosure of results from clinical trials annually. However, since eligibility for future funding can be tied to policy compliance, individual investigators may wish to proactively provide new information, by completing the compliance report again, over the course of the year. Compliance report responses are date/time stamped, and the most recent submission will be considered when evaluating compliance.

• Where can I find my previously submitted responses?

  The compliance report website will not store data for future use once the responses are submitted. We encourage respondents to use the last question of the report to have a copy of their responses sent to them for future reference.

• What are the consequences of not responding to this compliance report?

  Compliance with CIHR’s Policy Guide – Requirements for Registration and Disclosure of Results from Clinical Trials is a requirement for all clinical trials funded by CIHR on or after January 1, 2022. CIHR is committed to working with researchers in support of achieving compliance. While individual circumstances may be taken into consideration when interpreting compliance, failure to provide information requested by CIHR for the purposes of compliance with this policy may result in the withholding of new CIHR funds until all requirements have been met. Moreover, non-compliance with the policy may be considered a breach of the Tri-Agency Framework: Responsible Conduct of Research and may result in more serious recourse measures.

Date modified:

2026-01-26