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ClinicalTrials.gov

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Register/Update Your ClinicalTrials.gov Record (ClinicalTrials.gov - PRS)

Organization: UKansasMCRI

Request ClinicalTrials.gov - PRS Access

Contact KUMC PRS Admin

Request ClinicalTrials.gov Consultation

For cancer studies, contact the Clinical Trials Office

Background

ClinicalTrials.gov is a publicly accessible, online database of clinical trials that are maintained by the National Library of Medicine at the NIH. The purpose of the site is to increase transparency; remove bias in reporting; and provide the public, researchers, and groups involved in research with a free, accessible database of clinical trials and results. Federal law and other authorities require clinical trials meeting certain criteria to be registered on ClinicalTrials.gov.
Studies requiring registration that are initiated by a KUMC investigator or for which a KUMC investigator is the IND/IDE holder are created and maintained on ClinicalTrials.gov under one institutional account. The Clinical Research Administration office manages the ClinicalTrials.gov KU Medical Center account for non-cancer studies. The initial registration and continuing maintenance of each study registration is the responsibility of the "responsible party". The responsible party is either the Principal Investigator or KU Medical Center.

Do I need to register my study?

Use the Requirements Flowchart to determine if your study requires registration.

Three main policies and regulations require certain clinical trials to be registered on ClinicalTrials.gov:

ICMJE Clinical Trial Registration Policy

NIH Policy on Dissemination of NIH-Funded Clinical Trial Information

FDAAA 801 and 42 CFR Part 11 ("Final Rule") regulations

A study may require registration under one or more of these policies if it is an interventional clinical trial, an interventional NIH-funded clinical trial, and/or an Applicable Clinical Trial (ACT) under FDAAA 801.

A study may also require registration to meet the Centers for Medicare and Medicaid Services (CMS) billing requirement of providing the NCT number for all qualified claims. The NCT number is the ClinicalTrials.gov registry number generated when a study is registered on the site.

What resources does the Research Institute provide?

The PRS Administrator within the Clinical Research Administration provides PRS technical assistance, compliance information, record requirement notifications, assistance with record corrections, and training resources.

How can I request help with ClinicalTrials.gov?

Email questions and requests to clinicaltrials-gov@kumc.edu. You can also request training or assistance with your record via the ClinicalTrials.gov Request Form.

How do I register my study?

You will need a ClinicalTrials.gov PRS user account to create your study record. To request PRS access, contact the KUMC PRS Administrator at clinicaltrials-gov@kumc.edu.

Follow the ClinicalTrials.gov Registration Guide to create a new record.

You can use the Interventional Study Protocol Registration or the Observational Template to determine required fields and gather study information in advance of data entry into ClinicalTrials.gov.

The Registration Data Element Definitions provide additional field descriptions and examples.

The Registration QC Review Criteria describe formatting guidelines that will be reviewed before a record is posted publicly.

What are my record's requirements?

See the Record Lifespan flowchart for a summary of the steps of a typical ClincalTrials.gov record.

Use the Deadline Generator tool to determine your record's action deadlines and see the below table to determine what requirements and deadlines apply to your record:

Images/ri/RI ClinicalTrails FDA Regs

1Interventional Study Protocol Registration Template
2WHO - ICMJE Cross Reference

How do I submit study results?

Follow the ClinicalTrials.gov Results Guide to create a results section for your record.

The Results Data Element Definitions provide additional field descriptions and examples.

The Results of QC Review Criteria describe formatting guidelines that will be reviewed before a record is posted publicly.

ClinicalTrials.gov also provides results checklists, templates, and examples for the preparation of results submission.

It is recommended to submit results at least 2 months in advance of the due date. This is because results submissions may be returned from the PRS review with required corrections before public posting, and the PRS review for results submission can take up to 30 days.

How do I make PRS review corrections?

1.  Open the study record to the Record Summary page.
2.  Near the top of the page, select the pink "Review Comments" link by the red flag.  This will open a new window with the record information and included PRS comment boxes.
3.  PRS comments appear as red "Major Issues" and yellow "Advisory Issues" comment boxes.
4.  Back on the Record Summary page, open the sections with issues and edit to correct or address all major and advisory issues.
5.  Re-submit the record for PRS review.

How do I close or transfer Clincaltrials.gov records?

If you are a departing Principal Investigator or record owner for one or more KUMC ClinicalTrials.gov records, final actions for the records may be required as part of the off-boarding process.

Be sure to update your ClinicalTrials.gov user account with your new contact information or work with the ClinicalTrials.gov PRS Administrator (clinicaltrials-gov@kumc.edu) to disable your ClinicalTrials.gov user account. Also work with the ClinicalTrials.gov admin to determine and finalize record actions:

    1. For trials remaining open or pending results reporting:

      Trials that remain open or that will require results reporting may require a record transfer when there is not an IND/IDE or external funding remaining at KUMC. Notify the ClinicalTrials.gov admin to determine if transfer will be required, and if needed determine the receiving Record Owner, institutional account, and institutional ClinicalTrials.gov administrator to complete record transfer.

    2. For trials continuing at KUMC, contact the ClinicalTrial.gov admin complete the following as needed:
      • Complete any pending updates to reflect current record status
      • Identify individuals that can assume relevant record roles
      • Modify the Principal Investigator/Responsible Party
      • Notify responsibilities to the newly assigned Principal Investigator/Responsible Party
    3. For continued work or collaboration required once the departure is finalized, develop a plan with the ClinicalTrials.gov admin. Examples include:
      • Continued access needed to ClinicalTrials.gov records
      • Providing analysis and information to the department revising the record

If you are a new faculty member and Principal Investigator for ClinicalTrials.gov records to be transferred to the KUMC ClinicalTrials.gov institutional account, this can also be accomplished by contacting the ClinicalTrials.gov admin.

NEW Requirements

1-18-2017:"Final Rule" requires an additional data element, including submission of the full protocol and statistical analysis plan with results information. The "Final Rule" also added a requirement to correct or address PRS Comments for registration information within 15 days, and results in information within 25 days.

1-18-2017: The NIH Policy, complementary to the Final Rule, requires registration and results reporting of all NIH-funded interventional clinical trials, including clinical trials with behavioral interventions.

1-1-2019: ICMJE requires clinical trials that begin enrolling participants on or after 1 January 2019 to include a data sharing plan in the trial's registration.

1-21-2019: The revised "Common Rule" requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form used in enrolling participants be posted on a publicly available Federal Web site (ClinicalTrials.gov) no later than 60 days after the last participant study visit.

References

Last modified: Jun 12, 2019
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