How Will an Investigator Know If Their Trial Should Be Registered?
Investigators should review the statutory definition of applicable clinical trial to identify if any of their trials must be registered to comply with the law. NIH encourages registration of all trials whether required under the law or not, and ICMJE advises that those who are uncertain whether their trial meets the ICMJE definition of eligible trials should consider registering if they wish to seek publication in an ICMJE journal.
Since responsibility for registering trials lies with the lead sponsor of the clinical study, most "industry sponsored" trials will be registered by the sponsor, which can be a pharmaceutical company or CRO.
Dartmouth sponsor‐investigator studies (also known as "investigator‐initiated studies"), or those who hold an IND or IDE that meet the eligibility criteria, will all need to be registered by the investigator prior to study enrollment, where applicable.
If the sponsor of a clinical trial is someone other than the PI, investigators should communicate with the study sponsor to determine the Responsible Party for protocol registration, and personally check the registry to ensure that all of the required registration elements are included.
Multi-site trials and multi-sponsor trials are susceptible to duplicate registration, thus care must be taken in how the trials are registered. For multi-sponsor trials it is the lead sponsor who should take responsibility for registration. It is critical that investigators and sponsors work together to ensure that a trial is registered once and only once.
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