When to register on ClinicalTrials.gov?

The Responsible Party (that is, the sponsor or designated PI) for an Applicable Clinical Trial must submit required clinical trial information not later than 21 days after enrollment of the 1st participant. However, the University of Utah recommends registration of all trials on ClinicalTrials.gov prior to enrolling the 1st participant, to satisfy both the law and ICMJE requirements.

ICMJE guidelines currently define a clinical trial as, “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”  Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.

Exceptions:

For Applicable Clinical Trials that were (1) initiated on or before September 27, 2007, and (2) "ongoing" as of December 26, 2007:

•Trials involving a "serious or life threatening disease or condition" should have been submitted by December 26, 2007.

•Trials not involving a "serious or life threatening disease or condition" should have been submitted by September 27, 2008.

 

Further Information:

Statutory Provision on Data Submission

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=85

FDAAA 801 Requirements (ClinicalTrials.gov Website)

http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering

 

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