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Complying with ClinicalTrials.gov at IU
ClinicalTrials.gov, commonly known as CT.gov, is a database of privately and publicly funded clinical studies providing information about clinical trials to patients, family members, health care professionals, researchers, and the larger public.
Indiana University's ClinicalTrials.gov program assists the research community with registering and reporting on clinical trials and keeping up to date on regulatory changes and updates. IU's CT.gov compliance program also conducts mandatory monitoring and auditing of registration and for maintenance and results reporting in ClincalTrials.gov. Please note that the IU ClinicalTrials.gov compliance program monitors and audits selected records only. As a principal investigator, you are responsible for confirming that all records are maintained and that any outstanding problems are being continuously addressed.
For more information on the IU ClinicalTrials.gov compliance program:
Various entities, including the FDA, the International Committee of Medical Journal Editors (ICMJE), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS), have individually defined which studies must be registered on ClinicalTrials.gov. When you create a new study in Kuali Coeus IRB system with a review level of Expedited or Full Board, the ClinicalTrials.gov questionnaire must be completed. The questionnaire will ask you to identify all applicable requirements for registration. Information about each entity’s registration requirements is described on the ClinicalTrials.gov webpage. The National Clinical Trial Number is required for completed registrations.
ClinicalTrials.gov records are created and edited within CT.gov's Protocol Registration and Results System (PRS). To access the PRS, you must have a PRS user account. IU ClinicalTrials.gov program staff will assist you in obtaining a new account or modifying an existing account. To request a new user account, send an email to email@example.com and include the following information: account holder name, user name; email address; phone number; account holder official title.
If your current account is no longer accessible or requires modifications, send an email to firstname.lastname@example.org and include the following: account holder name and a description of the modification/issue.
The person who creates the study record in CT.gov becomes the record owner. The record owner may maintain the record or may grant additional users access to make record changes. All email communications from PRS will be sent to the record owner.
A record owner on an existing ClinicalTrials.gov record may need to be modified due to personnel or responsibility changes. To request modifications to an existing record owner, send an email to email@example.com and include the following information: National Clinical Trial Number; Institutional Review Board (IRB) protocol number; full name of new record owner; and account information if the user is new. The current record owner, the new record owner, and the principal investigator/responsible party must be copied on this request.
Clinical Trials.gov registration, record maintenance, problem resolution
Specific data elements, such as study design, outcome measures, eligibility criteria, as well as information about the study’s reviewing IRB and Data Monitoring Committee (if applicable), are required in the PRS system to register a study. Resources, including instructions and reference materials related to the study registration process, are available on both the CT.gov website and the PRS website. Once a study registration record has been completed by the user, it must be reviewed by both IU’s ClinicalTrials.gov program staff and by PRS staff before the study record will be published to the public CT.gov site.
Ongoing 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. The verification date in the ClinicalTrials.gov record needs to be modified at least every 12 months. It is advised that this date be updated every time the ClinicalTrials.gov record is accessed.
- Update ClinicalTrials.gov record within 15 days following a change to:
- Device approval status, if the device under investigation was not approved or cleared by the Food and Drug Administration at the time of study registration, but undergoes a change in approval or clearance status
- Update ClinicalTrials.gov record within 30 days following a change to:
- Study start date
- Intervention name
- Availability or type of expanded access
- Overall recruitment status
- Individual site status
- Human subjects protection review board status
- Primary completion date
- Study completion date
- Responsible party and contact information
- Protocol amendments
- Any content changes including modification needed to the posted protocol and/or statistical analysis plan
Detailed instructions available on the PRS website can assist you with record maintenance.
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.
Problems can occur during the creation and modification of a record on ClinicalTrials.gov. Resolving problems can be accomplished through the main menu, in the record, and are received through notifications from ClinicalTrials.gov. Editing a ClinicalTrials.gov record is advised and often required when a problem is encountered. ClinicalTrials.gov identifies four types of problems:
ERROR—Problem is serious.
WARNING—Problem is/may be required to be addressed 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. Warnings, alerts, and notes may cause issues with meeting regulatory or system requirements.
Detailed instructions on the PRS website can assist you with problem resolution.
Regulatory noncompliance and principal investigator/responsible party change
If you receive 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, you must notify the Office of Research Compliance at firstname.lastname@example.org within seven (7) days of receipt.
If 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, the affected ClinicalTrials.gov record must be modified.
Each of these procedures must occur when there is a change to the principal investigator/responsible party. If the change is expected, the following tasks must be completed 30 days prior to the expected change. If the change is unexpected, the following tasks must occur within 14 days following the unexpected change:
- Notify the Office of Research Compliance at email@example.com.
- 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.
- 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.
- If the trial is not continuing, mark the record as completed/terminated/withdrawn and modify the record to reflect the current clinical trial information.
- 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.
Depending on the qualities of the clinical trial, the record may be reassigned to another principal investigator/responsible party, transferred to another institution, or its status may be changed. The qualities include whether the trial will remain open, if there is an IND or IDE associated with the record that will remain at IU, if there is external funding for the trial that will remain at IU, and if results reporting is required. IU’s ClinicalTrials.gov program staff will assist you with this determination.
If the clinical trial will not remain open and if results reporting for the trial is not required, then and only then may the record status be changed to Completed/Terminated/Withdrawn without a change to the responsible party.
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. Examples of the statements are listed here:
A description of this clinical trial will be available on ClinicalTrials.gov, as required by federal law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
A description of this clinical trial will be available on ClinicalTrials.gov. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
Suggested language for National Institutes of Health grants
If you are seeking funding for a National Institutes of Health clinical trial, you are required to provide a plan describing how the expectations of the National Institutes of Health policy will be met. Examples of the grant language listed here:
ClinicalTrials.gov Dissemination Plan: The principal investigator will abide by the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. The investigator intends to register the trial, maintain and update the record, 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.
ClinicalTrials.gov Dissemination Plan: The investigator intends to coordinate with the lead principal investigator to ensure that all regulatory and policy requirements are met in compliance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. The investigator intends to provide necessary information to the lead PI to facilitate registering the trial, maintaining and updating the record, 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.
Clinical Trials.gov resources
Federal regulations, policies and guidance
- FDA, FDAAA, Title VIII, Section 801
- FDA, FDAAA, Final Rule
- NIH Final Policy
- NIH "Elaboration of Definitions of Responsible Party and Applicable Clinical Trial"
- FDA 21 CFR § 50.25(c) regulation on informed consent
- FDA informed consent guidance
- Identifying an ACT under FDAAA/NIH flow chart
- Identifying the responsible party under FDAAA/NIH flow chart
Other policies and recommendations
- International Committee of Medical Journal Editors "Clinical Trials Registration: A Statement from the International Committee of Medical Journal Editors", September 2004
- International Committee of Medical Journal Editors "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals", December 2016
- Centers for Medicare & Medicaid Services "Pub 100-04 Medicare Claims Processing: Transmittal 2955"