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Background 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
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 under one institutional account. The Clinical Research Administration office manages the 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.

Responsible Parties should update the Overall Recruitment Status or Individual Site Status in their study records. These data fields require updates within 30 calendar days after a change in status to help ensure that accurate up-to-date clinical trial information is available.

Refer to the list of recruitment status options and their definitions to determine the best answer based on the specific situation for your study.

If the Overall Recruitment Status is updated to Suspended, Terminated, or Withdrawn, provide a brief explanation for the reason why the study was stopped (e.g. “COVID-19”) as part of the Why Study Stopped data element.

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

Three main policies and regulations require certain clinical trials to be registered on

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 registry number generated when a study is registered on the site.

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

Email questions and requests to You can also request training or assistance with your record via the Request Form.

You will need a PRS user account to create your study record. To request PRS access, contact the KUMC PRS Administrator at

Follow the Registration Guide or the PRS Guided Tutorial 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

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.

See the Record Lifespan flowchart for a summary of the steps of a typical 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:

Clinical Trials FDA Regulations chart

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

Follow the Results Guide or the PRS Guided Tutorial 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. 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.

  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.

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

Be sure to update your user account with your new contact information or work with the PRS Administrator ( to disable your user account. Also, work with the 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 admin to determine if transfer will be required, and if needed determine the receiving Record Owner, institutional account, and institutional administrator to complete record transfer.

    2. For trials continuing at KUMC, contact the 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 admin. Examples include:
      • Continued access needed to records
      • Providing analysis and information to the department revising the record

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

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 ( no later than 60 days after the last participant study visit.

Research Administration

University of Kansas
Medical Center

Research Administration
Mailstop 1039
3901 Rainbow Boulevard
Kansas City, KS 66160

Fairway North, 1000
4330 Shawnee Mission Pkwy
Fairway, KS 66205
Phone: 913-588-1261
Fax: 866-255-2129