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Quality Improvement Office - ClinicalTrials.gov

Researcher Responsibilities

ClinicalTrials.gov Account Administration

Account Requests
Prior to all actions in ClinicalTrials.gov, an account is required and the account needs to be accessible by the account holder. Requests for new accounts need to be sent to ctgov@iu.edu and include the following in the email:

  • Full Name
  • Username
  • Email
  • Phone
  • Official Title

Requests for accounts that are no longer accessible by the account holder or require modifications need to be sent to ctgov@iu.edu and include the following:

  • Full Name
  • Modification/Issue Description

Record Owner Modification
A Record Owner on an existing ClinicalTrials.gov record may need to be modified due to personnel or responsibility changes.

Requests for a Record Owner modification need to be sent to ctgov@iu.edu and include the following in the email:

  • National Clinical Trial Number
  • Institutional Review Board (IRB) Protocol Number
  • Full name of new Record Owner
    • Include new account information if new user
  • Copy current Record Owner, new Record Owner and Principal Investigator/Responsible Party

ClinicalTrials.gov Registration Completion

ClinicalTrials.gov Questionnaire
When a New Study that has the level of review as either Expedited or Full Board is created in Kuali Coeus (KC) IRB, the ClinicalTrials.gov questionnaire requires responses. The questionnaire requires that the study be classified using 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 clinical trial criteria. For completed registrations, the National Clinical Trial Number is required.

Record Registration
Registration is required for Applicable Clinical Trials and National Institutes of Health clinical trials on ClinicalTrials.gov.

Please note that the Indiana University, ClinicalTrials.gov Compliance Program will be monitoring and auditing for Applicable Clinical Trials and National Institutes of Health clinical trials only. All other registration requirements will need to be monitored by the investigator.

ClinicalTrials.gov Maintenance Completion

Results Reporting
Providing results reporting for the ClinicalTrials.gov record is required for Applicable Clinical Trials and National Institutes of Health clinical trials 12 months after the Primary Completion Date.

Please note that the Indiana University, ClinicalTrials.gov Compliance Program will perform scheduled monitoring and auditing on selected records only. It is the responsibility of the investigator to confirm that records are being maintained and that outstanding problems are being continuously addressed.

Problem Resolution
Problems can occur during the creation and modification of a record on ClinicalTrials.gov. Problems can be accessed through the main menu, in the record and are received through notifications from ClinicalTrials.gov. ClinicalTrials.gov identifies 4 types of problems that can occur. Editing a ClinicalTrials.gov record is advised and often required when a problem is encountered.

ERROR = Problem is serious

WARNING = Problem is/may be required by Food and Drug Administration Amendments Act of 2007 801

ALERT = Problem needs to be addressed

NOTE = Potential problem needs to be addressed

An error can stop completion of ClinicalTrials.gov record status changes. Warning, alerts and notes may cause issues with meeting regulatory or system requirements.

Please note that the Indiana University, ClinicalTrials.gov Compliance Program will perform scheduled monitoring and auditing on selected records only. It is the responsibility of the investigator to confirm that records are being maintained and that outstanding problems are being continuously addressed.

Record Maintenance
Maintenance and updates to the ClinicalTrials.gov record are required for Applicable Clinical Trials and National Institutes of Health clinical trials. Editing a ClinicalTrials.gov record is required when a reportable modification is made or an update to the verification date is completed.

  • Update ClinicalTrials.gov record within 15 days following a change to the following:
    • Device not approved or cleared by the Food and Drug Administration updated after a change in approval or clearance status
  • Update ClinicalTrials.gov record within 30 days following a change to the following:
    • Study start date
    • Intervention name
    • Availability of expanded access
    • Expanded access record
    • Overall recruitment status
    • Individual site status
    • Human subjects protection review board status
    • Primary completion date
    • Study completion date
    • Responsible party
    • Responsible party contact information
    • Protocol amendments
      • Any content changes including modification needed to posted protocol and/or statistical analysis plan

The verification date in the ClinicalTrials.gov record needs to be modified every 12 months. It is advised that this date be updated every time the ClinicalTrials.gov record is accessed.

Please note that the Indiana University, ClinicalTrials.gov Compliance Program will perform scheduled monitoring and auditing on selected records only. It is the responsibility of the investigator to confirm that records are being maintained and that outstanding problems are being continuously addressed.

Regulatory Noncompliance and Principal Investigator/Responsible Party Change

External Agency Letter Notification
A member of the research community must notify Office of Research Compliance at ctgov@iu.edu 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.

Principal Investigator/Responsible Party Change Notification and Modification
In the event the Principal Investigator acting as the Responsible Party on a ClinicalTrials.gov record leaves the institution, is no longer involved with the clinical trial, becomes incapacitated or dies, a notification needs to be sent to Office of Research Compliance and a modification to the impacted ClinicalTrials.gov record may need to occur.

Expected Principal Investigator/Responsible Party Personnel Change

  • Notify Office of Research Compliance 30 days prior to an expected Principal Investigator/Responsible Party personnel change.
  • If the trial is active, complete the modification to the Principal Investigator/Responsible Party, modify the record to reflect the current clinical trial information and notify the newly assigned Principal Investigator/Responsible Party of responsibilities 30 days prior to an expected personnel change.
    • If the clinical trial is a candidate for a record transfer, work with Office of Research Compliance to discuss a ClinicalTrials.gov record transfer and assist with the record transfer process during the 30 days prior to an expected personnel change.
  • If the trial is not continuing, mark the record as completed/terminated/withdrawn and modify the record to reflect the current clinical trial information 30 days prior to an expected personnel change.
    • In the event of a record that is given this status, but requires results, a modification to the Principal Investigator/Responsible Party or record transfer is still required.

Unexpected Principal Investigator/Responsible Party Personnel Change

  • Notify Office of Research Compliance 14 days following an unexpected Principal Investigator/Responsible Party personnel change.
  • If the trial is active, complete the modification to the Principal Investigator/Responsible Party, modify the record to reflect the current clinical trial information and notify the newly assigned Principal Investigator/Responsible Party of responsibilities 14 days following an unexpected personnel change.
    • If the clinical trial is a candidate for a record transfer, work with Office of Research Compliance to discuss a ClinicalTrials.gov record transfer and assist with the record transfer process during the 14 days following an unexpected personnel change.
  • If the trial is not continuing, mark the record as completed/terminated/withdrawn and modify the record to reflect the current clinical trial information 14 days following an unexpected personnel change.
    • In the event of a record that is given this status, but requires results, a modification to the Principal Investigator/Responsible Party or record transfer is still required.

Record Reassignment, Transfer and Status Change

Depending on the qualities of the clinical trial, the record may be re-assigned to another Principal Investigator/Responsible Party, transferred to another institution or complete a status change.

Informed Consent Documentation

Applicable Clinical Trials and National Institutes of Health clinical trials are required to include a word-for-word statement regarding ClinicalTrials.gov registration in the Informed Consent documentation.

Applicable Clinical Trial Informed Consent Statement:

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 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.

National Institutes of Health Clinical Trial Informed Consent Statement:

A description of this clinical trial will be available on http://www.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.

National Institutes of Health Grant Documentation

As a part of the grant process, an applicant seeking funding for a National Institutes of Health clinical trial is required to provide a plan describing how the expectations of the National Institutes of Health policy will be met.

Suggested grant template language where Indiana University Principal Investigator is Lead Principal Investigator:

ClinicalTrials.gov Compliance Plan

The investigator intends to register and submit results information to ClinicalTrials.gov, consistent with policy and regulatory requirements. The Indiana University Office of Research Compliance, in collaboration with the Indiana CTSI, offers a robust compliance program and provides guidance to investigators in meeting their policy and regulatory obligations. The Indiana University Office of Research Compliance website outlines the institutional compliance plan and policy: http://researchcompliance.iu.edu/qio/qio_ctgov.html.

Suggested grant template language where Indiana University is a site but Indiana University Principal Investigator is not the Lead Principal Investigator:

ClinicalTrials.gov Compliance Plan

The investigator intends to coordinate with the Lead Principal Investigator to ensure that all regulatory and policy requirements are met in regards to registering and submitting results information to ClinicalTrials.gov. The Indiana University Office of Research Compliance, in collaboration with the Indiana CTSI, offers a robust compliance program and provides guidance to investigators in meeting their policy and regulatory obligations. The Indiana University Office of Research Compliance website outlines the institutional compliance plan and policy: http://researchcompliance.iu.edu/qio/qio_ctgov.html.


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