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Quality Improvement Office

ClinicalTrials.gov Compliance Program

Compliance Program Purpose

ClinicalTrials.gov is a public registry aimed at increased transparency and improved public awareness of research. Information about individual clinical trials is added to ClinicalTrials.gov through a registration process. Various regulatory bodies and committees have promoted both definitions of those clinical trials required to register and the necessity of results reporting. Indiana University has both a policy and compliance program that aims to assist the research community with obligations and mitigate risks associated with noncompliance. Indiana University continuously evaluates the regulatory environment with regards to ClinicalTrials.gov requirements and updates both the policy and compliance program as necessary.

Click here to view the Indiana University, ClinicalTrials.gov Compliance program at a glance.

Regulatory and Policy Requirements

Registration of a clinical trial in ClinicalTrials.gov and maintenance of the clinical trial record is required by several regulatory bodies and committees. Additionally, failure to comply can result in penalties. Food and Drug Administration Amendments Act of 2007 801, National Institutes of Health, International Committee of Medical Journal Editors and Centers for Medicare and Medicaid Services are the most commonly referenced requirements. Please note that the clinical trial may be subject to other policy or sponsor requirements.

Regulation/Policy Timeline for Registration Results Reporting Required Penalty for Not Complying
Food and Drug Administration Amendments Act of 2007 801 21 days post first subject enrollment Yes Initial $10,000 and $10,000/day for the duration of the violation (uncorrected violations), withholding of funds, sanctions
ICMJE At or before first subject enrollment No Inability to publish in prominent journals
CMS Prior to submission of claim No Claims will not be paid
NIH 21 days post first subject enrollment Yes Withholding cash payments, disallowing cost of activity, suspending or terminating current award, withholding future award.

Indiana University Responsibilities

Indiana University is responsible for hosting a compliance program that provides administration, monitoring, auditing, reporting and training for the ClinicalTrials.gov registration, maintenance and results reporting processes completed by affiliated Indiana University investigators.

Office of Research Compliance Operational Responsibilities

Office of Research Compliance depends on the Quality Improvement Office to perform the following functions:

  • Administer ClinicalTrials.gov accounts
  • Assist in determining if a clinical trial is an Applicable Clinical Trial or National Institutes of Health clinical trial and requires compliance with Food and Drug Administration Amendments Act of 2007 801 or National Institutes of Health policy requirements
  • Monitor and audit research community activity and responsibilities within ClinicalTrials.gov
  • Monitor compliance program
  • Report to executive management on compliance program progress
  • Train internal staff and research community on the Indiana University, ClinicalTrials.gov policy and operations
  • Handle inquiries/concerns from the research community

Research Community Responsibilities

The Research Community, including Principal Investigators determined to be the Responsible Parties of Applicable Clinical Trials or National Institutes of Health clinical trials, performs the following functions:

  • Request of account administration needs
  • Correctly identify the Responsible Party for a clinical trial requiring action on ClinicalTrials.gov
  • Create records on ClinicalTrials.gov
  • Approve and release actions associated with ClinicalTrials.gov records
    • Confirm accuracy of content in record
  • Resolve problems on ClinicalTrials.gov
  • Maintain records on ClinicalTrials.gov including addressing in a timely manner all regulatory and policy driven updates and results reporting, if required
  • Attend or utilize training
  • Notify Office of Research Compliance of receipt of any correspondence from an external agency regarding Food and Drug Administration Amendments Act of 2007 801 requirements, National Institutes of Health policy requirements, a ClinicalTrials.gov record, registration requirements, maintenance requirements or results reporting requirements within seven days of receipt
  • Notify Office of Research Compliance 30 days prior to an expected and 14 days following an unexpected Principal Investigator/Responsible Party personnel change. If required, complete the modification to the Principal Investigator/Responsible Party in the impacted ClinicalTrials.gov record 30 days prior to an expected and 14 days following an unexpected personnel change or work with Office of Research Compliance in completing a record transfer

Indiana University, ClinicalTrials.gov Compliance Program Processes

Processes for evaluating registration, maintenance and results reporting in ClinicalTrials.gov are utilized to provide effective monitoring, auditing and risk mitigation.


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