ClinicalTrials.gov


What is it:

A Clinical Trial Registry maintained by the U.S. National Institutes of Health.

Purpose:

To serve as a mechanism for researchers to register clinical trials when they begin, provide timely updates, submit summary results, and make this information publicly available as part of a mechanism to provide increased stewardship, transparency, and access to clinical trials information and results.

Legal and Publication Requirements:

Trial registration is required by law under Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) which requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices.

In September 2016, under an HHS/NIH initiative, changes were made to both Clinicaltrial.gov reporting requirements through changes in 42 CFR Part 11 and NIH procedures including clinical trial definition, application requirement, Good Clinical Trial (GCP) status and training requirements to enhance stewardship and improve visibility of clinical trial activities and results information. The following references summarize the related Guide notices, the new regulation, and articles published by NIH leadership in scientific journals.

  • For an overview and rationale for the various clinical trial related changes, see the NIH blog, Building Better Clinical Trials through Enhanced Stewardship and Transparency
  • For information on the regulation and new NIH policy on registering clinical trials and reporting summary results in ClinicalTrials.gov, see the NIH blog: Improving Visibility of NIH-supported Clinical Trial Activities and Results Information

In addition to the Final Rule and NIH policy, NIH has made available a number of resources to help explain the changes, and will be rolling out more over the upcoming months. Resources available now include:

In July 1, 2005, the International Committee of Medical Journal Editors (ICMJE) decided that no trials will be considered for publication unless they are included on a clinical trials registry. Therefore even if your research is not identified as a GCP study, you may need to register your research using human subjects (even if it is behavioral study and no drug is involved) at clinicaltrials.gov in order to publish in many journals today.

Create an Account

Colorado State University has an organizational account. Investigators at CSU are designated as users in this university-wide account and will have their own user name and login. A member of CSU’s Quality Program serves as the Administrator and contact person for all CSU accounts.

Request A ClinicalTrials.gov Account

Responsibilities:


Administrator (CSU)

  • Maintains PRS Organizational Account
  • Creates User accounts
  • Has access to all study records
  • Monitors records in account for Problems
  • Approves and releases records when the Organization is the
  • Sponsor and Responsible Party

Users (Responsible Party): Creates and Edits records

  • Responsible for maintaining individual trial records accurately and in within required timeframes
  • Only has access to their records
  • Owner or on the Access List
  • Approves and releases records
  • Principal Investigator is typically the Responsible Party

Who should create an account?

To avoid duplicate entries for a single study, studies should be registered only by the Responsible Party. Responsible parties are solely responsible for the content, quality and timeliness of registration and results reporting in accord with FDAAA. They are considered the Sponsor of the trial, the IND/IDE holder, or person or entity who initiated the trial, or funding recipient, or the funder if it is a contract.

Responsible Party

The responsible party for an applicable clinical trial (ACT) subject to FDAAA must:

  1. Register the ACT in ClinicalTrials.gov no later than 21 days after enrollment of the first participant;
  2. Update the ACT in ClinicalTrials.gov at least once every 12 month (Recruitment Status and Primary Completion Date within 30 days)
  3. Submit summary results (including adverse event information) for certain trials not later than 1

Provide Summary Results

All data is entered in a tabular format; no written results or conclusion

When must summary results be submitted?

  • Within 12 months of (primary) completion date
  • “The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primar outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.”
  • OR within 30 days of product approval or clearance
  • Delays possible
  • Seeking approval of a new use
  • Extensions for “good cause”

CSU Specific Information


Social Behavioral and Educational Research IRB

IRB Name: Colorado State U IRB #1
IRB Affiliation: Colorado State University
Oversight Authorities: United States: Federal
FWA Number: 00000647 (03/17/2021 (last updated 3/17/2016))
IORG (Institution/Organization) number: 0000122
IRB Number: 00000202 (expires 3/16/19 (last updated 3/16/16))

Biomedical Research IRB

IRB Name: Colorado State U IRB #1
IRB Affiliation: Colorado State University
Oversight Authorities: United States: Federal
FWA Number: 00000647 (expires 5/3/18 (last updated 6/21/13))
IORG (Institution/Organization) number: 0000122
IRB Number: 00000202 (expires 3/16/19 (last updated 3/16/16))

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