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Trial Registration

1. How do I register my clinical study on ClinicalTrials.gov?

Sunnybrook Health Sciences Centre has an organizational account with ClinicalTrials.gov. To obtain a user account for registering your clinical study with ClinicalTrials.gov, contact the Research Ethics Coordinator, who is the protocol registration system (PRS) administrator for Sunnybrook.

NOTE: Once a study is registered, you are responsible to ensure that the information entered is accurate and up to date (i.e. overall recruitment status, study completion date, enrollment). If during the course of the study there is a protocol amendment, the affected data elements (i.e., eligibility criteria) must be updated.

2. How do I know when registration is required for a research study?

Published in September 2016, the NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.

In regards to your trial, ask yourself these questions:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then we consider your research a clinical trial, and therefore the trial should be registered.

Reference: https://nexus.od.nih.gov/all/2017/08/11/4-questions-for-researchers-and-institutions-involved-in-human-subjects-research/

3. Do I need to update the ClinicalTrials.gov record for a study if the record owner or responsible party leaves the study?

Yes, this information must be updated in ClinicalTrials.gov to reflect the new record owner and/or responsible party.  Please see 7.3 “Changing Record Owner” and 7.4 “Transferring a record to/from a different organization” in the ClinicalTrials.gov FAQ for step-by-step instructions to make this change in your study's ClinicalTrials.gov record.  

For further information and other helpful FAQs, please visit the following site: https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5234