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New initiative aimed at mitigating risks associated with
record registration and maintenance in ClinicalTrials.gov

January 2, 2015

The ClinicalTrials.gov Compliance program, a new initiative aimed at mitigating risks associated with record registration and maintenance in ClinicalTrials.gov, initiated on January 1, 2015. The Office of Research Compliance, Quality Improvement Office manages the ClinicalTrials.gov Compliance program.

The ClinicalTrials.gov questionnaire in KC IRB was released on December 4, 2014 and obtains information on the type of clinical trial being conducted and the current registration status of the record in ClinicalTrials.gov. The ClinicalTrials.gov questionnaire responses are utilized by the ClinicalTrials.gov Administrator in assessing Applicable Clinical Trial determinations, Responsible Party determinations and identifying required actions in ClinicalTrials.gov. The ClinicalTrials.gov Administrator may be in contact with researchers and study teams as required actions in ClinicalTrials.gov are identified.

A modification to the existing ClinicalTrials.gov structure at Indiana University includes Responsible Party identification. When Indiana University is identified as the Responsible Party, that role will be delegated to the qualified Principal Investigator. All new and existing ClincalTrials.gov records that identify Indiana University as the Responsible Party will require a modification to identify the Principal Investigator as the Responsible Party. Video instructions on actions required by Principal Investigators identified as the Responsible Party in ClinialTrials.gov will soon be available at http://researchcompliance.iu.edu/qio/qio_ctgov.html.

For questions about the ClinicalTrials.gov questionnaire and the ClinicalTrials.gov Compliance program, please contact the ClinicalTrials.gov Administrator at ctgov@iu.edu. Additionally, the ClinicalTrials.gov Compliance program has a new website at http://researchcompliance.iu.edu/qio/qio_ctgov.html where compliance program documentation and guidance can be found.