ClinicalTrials.gov Requirements

What is ClinicalTrials.gov?

ClinicalTrials.gov is a public database containing information about federally and privately supported clinical trials for an array of diseases and conditions. A service of the U.S. National Institutes of Health (NIH) in collaboration with the Food and Drug Administration (FDA), ClinicalTrials.gov requires registration and results reporting for clinical trials. Background information regarding history, policies, and laws can be found on ClinicalTrials.gov. Section 801 of the Food and Drug Administration Act (FDAAA 801) specifies registration and results reporting requirements for clinical trials (for full documentation describing the law, see FDAAA 801). The purpose of this page is to help investigators at the University of Iowa (UI) understand their responsibilities for ClinicalTrials.gov registration and results reporting.

Final Rule Update

Please note that this information may be subject to the regulatory freeze pending review issued by the new presidential administration. The U.S. Department of Health and Human Services has issued a final rule (42 CFR 11) about ClinicalTrials.gov. For more information, please see the HHS news release and NIH Office of Science Policy blog post. The Final Rule indicates that all Applicable Clinical Trials (ACT) must be registered on ClinicalTrials.gov on January 18, 2017. This rule must be applied at all institutions no later than April 18, 2017. Institutions found in violation of this rule could be subject to civil penalties of up to $11,383, as well as an additional $11,383 per day, if the issue is not resolved within 30 days. Additionally, funding to the institution can be reduced or stopped until this issue is resolved, and this could impact future funding for the institution. Besides civil penalties, criminal penalties are also possible for investigators found in non-compliance of this rule. A checklist-based tool to assist responsible parties in evaluating whether a study is an applicable clinical trial based on 42 CFR 11.22(b) for studies initiated on or after 1/18/17 is now available here.

  1. Who is Required to Register?
  2. When Must I Register to ClinicalTrials.gov?
  3. What is an Applicable Clinical Trial (ACT)?
  4. Is Registering on ClinicalTrials.gov the Only Step I Need To Take?
  5. Applicable Deadlines
  6. NIH and ICMJE Reporting Requirements
  7. When is the Reportable Party Required to Report Results?
  8. What About Observation and Expanded Access Studies?
  9. How do we Report?
  10. Where can I get Training on ClinicalTrials.gov?
  11. Should I Register at ClinicalTrials.gov, or with the IRB First?
  12. How Do I Identify this Information in HawkIRB?
  13. Who can Answer Questions at the University of Iowa?

 

1. Who is Required to Register?

Applicability of Requirements in 42 CFR Part 11

Clinical trials registration and results reporting is required by law. At the University of Iowa, the Principal Investigator (PI) is considered the responsible party for all clinical trials, unless the study is industry sponsored. If the sponsor is not a University of Iowa faculty or staff member, the responsibility of reporting to ClinicalTrials.gov falls upon the sponsor who initiated the study protocol.

For sponsor-initiated studies, the sponsor may register the entire multi-site trial; however, you may be responsible if:

You hold the Investigational New Drug Application (IND) or the Investigational Device Exemption (IDE) for your study (responsible party = sponsor-investigator);

Your study involves the UI serving as the coordinating center for a clinical trial under a prime award (as opposed to a subcontract) and the trial is investigator-initiated;

You do not hold the IND or IDE for your study, but you know that your Sponsor/funding agency has delegated you the responsibility to comply with the registration requirements (or if you can easily ascertain this from your contract or other award documentation); and/or

The clinical trial is regulated by the FDA (phase II through IV trial) and involves a drug, biologic or device, but does not require an IND/IDE.

For studies that have the UI as the IRB of record, the HawkIRB application captures trial information and NCT# in Section VII.B.1. Entering a NCT# is required for Phase 2-4 studies and is currently optional for Phase 1 studies.

Find more information at ClinicalTrials.gov under "Who is Responsible for Registering Trials and Submitting Results?"

 

2. When Must I Register to ClinicalTrials.gov?

Registration must be completed with ClinicalTrials.gov within 21 days of enrollment of the first subject in a trial and updated at least every 12 months. For more information, see ClinicalTrials.gov (“Which Trials Must Be Registered and Have Results Submitted to ClinicalTrials.gov?”). Additionally, studies involving NIH funding, or which plan to publish in ICMJE or other journals, will have additional requirements to consider for registration on ClinicalTrials.gov (please see ‘NIH and ICMJE Reporting Requirements’ section).

 

3. What is an Applicable Clinical Trial (ACT)?

CT.gov ACT Criteria
*Checklist taken from https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
A Clinical Trial is considered an Applicable Clinical Trial (ACT) when the above criteria are met. More information can be found here.

 

4. Is Registering on ClinicalTrials.gov the Only Step I Need to Take?

No, registering in ClincalTrial.gov’s PRS system is only the first step. FDAAA 801 and the Final Rule require reporting of results, adverse events (expected and unexpected), as well as modifications or updates to the study. Additionally, there may be other guidelines to follow if the study has NIH funding, or is planned to be published in an ICMJE, or other journal. These organizations each have their own rules for adhering to the Final Rule and FDAAA 801, which should be considered.

 

5. Applicable Deadlines

Data Element

Deadline for Updating 

(i.e., not later than the Specified Date)

Study Start Date

30 calendar days after the first subject is enrolled

Overall Recruitment Status

30 calendar days after a change in overall recruitment status

  • If the overall recruitment status is changed to "suspended," "terminated," or "withdrawn," the Why Study Stopped data element must be updated at that time as well

IRB Approval Status

30 calendar days after a change in status

Primary Completion Date

30 calendar days after the clinical trial reaches its actual primary completion date

Enrollment

At the time the primary completion date is changed to "actual," the actual number of participants enrolled must be submitted

Study Completion Date

30 calendar days after the clinical trial reaches its actual study completion date

Responsible Party, by Official Title

30 calendar days after a change in the Responsible Party or the official title of the Responsible Party

Responsible Party Contact Information

30 calendar days after a change in the Responsible Party or the contact information for the Responsible Party

Device Product not Approved or Cleared by US FDA

15 calendar days after a change in approval or clearance status has occurred

Record Verification Date

Any time the Responsible Party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

*Table Shared by Stanford University

 

6. NIH and ICMJE Reporting Requirements 

Element Final Rule NIH Policy ICMJE Policy
Scope/Applicability

Applicable clinical trials of FDA-regulated drug, biological, and device products and pediatric post-market surveillance studies of devices required by the FDA under the FD&C Act.

Does not apply to phase 1 trials or small feasibility studies.

Applicable clinical trials are (1) clinical trials of drug and biological products that are controlled, clinical investigations, other than phase 1 investigations of a product subject to FDA regulation; and (2) prospective clinical studies of health outcomes comparing an intervention with a device product against a control in humans (other than small feasibility studies) or any pediatric post-market surveillance studies required by FDA under the FD&C Act.

Applies to public and private sector sponsors and other entities who meet the definition of a responsible party.

All clinical trials funded wholly or partially by NIH.

Includes phase 1 clinical trials and trials that do not involve any FDA regulated product such as trials involving only behavioral interventions.

Applies to NIH-funded clinical trials where applications or proposals are received by NIH on or after the policy’s effective date.

Applies to NIH-conducted clinical trials initiated on or after the policy’s effective date.
All clinical trials which wish to publish in an ICMJE journal, or its affiliates, must register prior to enrolling the first subject. Currently, only registration is mandated.

Timeframe for registration on ClinicalTrials.gov

Not later than 21 days after enrollment of the first participant.

Not later than 21 days after enrollment of the first participant.

Prior to enrollment of first subject.

Registration data elements to be submitted to ClinicalTrials.gov

Elements defined in the final rule. Consists of descriptive information, recruitment information, location and contact information, and administrative data.

Elements defined in the final rule. Consists of descriptive information, recruitment information, location and contact information, and administrative data.

Elements defined in the final rule. Consists of descriptive information, recruitment information, location and contact information, and administrative data.

Timeframe for results information submissions to ClinicalTrials.gov

Not later than 12 months after primary completion date; possible delay of up to an additional 2 years for trials of unapproved products or of products for which initial FDA marketing approval or clearance is being sought, or approval or clearance of a new use is being sought.

Not later than 12 months after primary completion date; possible delay of up to an additional 2 years for trials of unapproved products or of products for which initial FDA marketing approval or clearance is being sought, or approval or clearance of a new use is being sought.

Not mandated in policy, but must meet the requirements of FDAAA 801.

Results data elements to be submitted to ClinicalTrials.gov

Elements defined in the final rule. Includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, and statistical analysis plan, and administrative information.

Elements defined in the final rule. Includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, and statistical analysis plan, and administrative information.

Elements defined in the final rule. Includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, and statistical analysis plan, and administrative information.

Potential Consequences of Non-compliance

  • Identifying clinical trial record as non-compliant in ClinicalTrials.gov
  • For Federally funded trials, grant funding can be withheld if required reporting cannot be verified.
  • Civil monetary penalties of up to $11, 383 per day
  • May lead to suspension or termination of grant or contract funding
  • Can be considered in future funding decisions
  • Identifying clinical trial record as non-compliant in Clinical Trials.gov
  • Inability to publish in ICMJE or affiliated journal

Effective date

1/18/2017

1/18/2017

Currently in effect

Compliance Date

4/18/2017

4/18/2017 N/A
*Table elements taken from https://www.nih.gov/news-events/summary-table-hhs-nih-initiatives-enhance-availability-clinical-trial-information

NIH and ICMJE affiliates (as well as many other journals) have even more stringent criteria for submitting to ClinicalTrials.gov. It is recommended that each PI be aware of each of these rules, or to practice following the most stringent of these to assure compliance.

 

7. When is the Responsible Party Required to Report Results?

In general, the law and federal funding entities require responsible parties to report summary results information for interventional studies of drugs, biological products, and devices within 1 year of the primary completion date of the study, regardless of sponsor or funding source.

Prior to submitting results data, it is recommended you review the “How to Submit Your Results” guidance on ClinicalTrials.gov.

 

8. What about Observational and Expanded Access Studies?

Both Observational and Expanded Access Studies can be registered in ClinicalTrials.gov’s PRS system, however, only Expanded Access studies require registration and reporting in ClinicalTrials.gov.

 

9. How do we Report?

For more information visit the “Submit Studies” page on ClinicalTrials.gov.

Individuals applying for an account to register a study through ClinicalTrials.gov should contact ct-gov@uiowa.edu(link sends e-mail) or 319-384-4623.

 

10. Where can I get Training on ClinicalTrials.gov?

ClinicalTrials.gov PRS system offers many modules, help, and advice for completing the registration, maintenance, and results reporting required per FDAAA 801 and the Final Rule. University of Iowa researchers should contact their PRS Administrator at ct-gov@uiowa.edu with additional questions.

 

11. Should I Register at ClinicalTrials.gov, or With the IRB First?

The University of Iowa requires that your HawkIRB number is used as your ‘Unique Protocol Identification Number’ in the PRS system at ClinicalTrials.gov. As such, it is recommended that the HawkIRB application be started first, and submitted to the IRB so that an IRB number can be assigned. The NCT number in the IRB application can be left blank until it has been assigned. This number can be updated in the IRB application at any time through a modification.

 

12. How Do I Identify this Information in HawkIRB?

Section VII.B of the HawkIRB application is where you will identify your clinical trial and find the link to the ClinicalTrials.gov database to register your study. VII.B.1 should identify ‘Clinical Trial’ as the study type, and additional questions can be answered, as appropriate.

 

13. W​ho Can Answer Questions at UI?

The Human Subjects Office has partnered with the Holden Comprehensive Cancer Center, for research utilizing cancer center resources, to assist University of Iowa researchers with questions related to ClinicalTrials.gov requirements.

Individuals applying for an account with ClinicalTrials.gov through UI should contact

Brian Brotzman

ct-gov@uiowa.edu(link sends e-mail) or 319-384-4623

Protocol Registration and Results System (PRS) Administrator at UI
Phone: 319-335-6564
Email: ct-gov@uiowa.edu(link sends e-mail)