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Beginning January 18, 2017
New ClinicalTrials.gov Compliance Regulatory and Policy Changes

January 6, 2017

Changes to ClinicalTrials.gov compliance for both the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) take effect on January 18, 2017.

The FDA requires completion of new registration data elements for all clinical trials meeting the Applicable Clinical Trial definition with a Study Start Date on or after January 18, 2017. Completion of new results reporting data elements is required for Applicable Clinical Trials with a Primary Completion Date on or after January 18, 2017. All Applicable Clinical Trials with a Primary Completion Date on or after January 18, 2017 will be required to complete results reporting regardless of the drug, biologic or device status with the FDA.

The NIH requires registration and results reporting for NIH funded clinical trials meeting the NIH clinical trial definition. NIH clinical trials funded by the NIH Intramural Program and initiated on or after January 18, 2017 are required to comply with the NIH policy. NIH clinical trials funded by the NIH Extramural Program with an application for funding submitted on or after January 18, 2017 and initiated on or after January 18, 2017 are required to comply with the NIH policy.

NIH clinical trials covered by the NIH policy are required to include a word-for-word statement regarding ClincalTrials.gov registration in the Informed Consent documentation.

A description of this clinical trial will be available on ClinicalTrials.gov. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

As a part of the grant process, an applicant seeking funding for an NIH clinical trial covered by the NIH policy is required to provide a plan describing how the expectations of the NIH policy will be met. Meeting the expectations of the NIH policy is considered a term and condition of the award. The cost of complying with the NIH policy can be covered by the grant. Progress report forms will require a certification that the expectations of the NIH policy have been met and the completion of required actions in ClinicalTrials.gov will be reviewed prior to the release of remaining or future funding.

Several key changes to the IU ClinicalTrials.gov Compliance Program are being implemented to address these requirements including a revised Kuali Coeus (KC) IRB questionnaire. Key changes will be communicated through the Research Compliance Quarterly Newsletter and updates can be reviewed on the IU ClinicalTrials.gov Compliance Program webpage.

For more information, please review the NIH News Release on the FDA final rule and the NIH policy.

For questions, concerns or to request a departmental training session, please email ctgov@iu.edu.