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ClinicalTrials.gov Resources

What is ClinicalTrials.gov?

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.  ClinicalTrials.gov also provides transparency to the public about research outcomes. 

What studies must be registered on ClinicalTrials.gov?

  • Any research project that:

(1) intends to seek publication in a journal that adheres to ICMJE policy AND
(2) prospectively assigns people (or groups of people) to an intervention with or without concurrent comparison or control) AND
(3) studies the relationship/impact of the health-related intervention on health outcomes
See  http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

OR

  • Any research project that:

(1) Applied for NIH support on or after January 18, 2017
(2) Is funded or supported by NIH
(2) Involves human participants prospectively assigned to an intervention AND
(3) is designed to evaluate the effect of the intervention on the participants’ health-related, biomedical or behavioral outcome.
See  https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

OR

OR

  • Any study meeting the definition of “Qualifying Clinical Trial” seeking Medicare payment for routine costs in a Clinical Trial under NCD 301.1 

Who is the Responsible Party?

At UMMS, the Principal Investigator is the Responsible Party for clinicaltrials.gov.  

What studies must be actively maintained, and reviewed at least annually on ClinicalTrials.gov?

All studies registered on clinicaltrials.gov must be reviewed at least annually, and updated within 30 days of certain changes to the study. 

What studies must report results on ClinicalTrials.gov?

  • Any research project that:

(1) Applied for NIH support on or after January 18, 2017
(2) Is funded or supported by NIH
(2) Involves human participants prospectively assigned to an intervention AND
(3) is designed to evaluate the effect of the intervention on the participants’ health-related, biomedical or behavioral outcome.
See  https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

OR

Quick Summary Table

 

Registration

Annual Maintenance

Updates

Results Reporting

ICMJE

X

X

X

 

NIH

X

X

X

X

Applicable Clinical Trials (FDAAA 801)

X

X

X

X


Get Started

Get Help 

ClinicalTrials.gov PRS Administrator for UMass Medical School:

Consultation and statistical help and support for trial design, outcomes planning and result analysis/reporting is available from the UMass Center for Clinical & Translational Science (UMCCTS) Quantitative Methods Core (QMC).  Select “Request a Consultation” at https://www.umassmed.edu/pqhs/qmc/ 

Get Training

Upcoming sessions TBD

What are the UMass Medical School standard operating procedures for ClinicalTrials.gov?

The University of Massachusetts Medical School Standard Operating Procedures are available by clicking the links below:

Standard Operating Procedures:

CTGov-001 Account Requests and Maintenance
Information on: Getting an account, Departing account holders, Changes to Responsible Party/study team access

CTGov-002 Registration and Responsible Party Determination
Information on: What studies must be registered, Who is the responsible party

CTGov-003 Registration

CTGov-004  Record update and Maintenance
Information on: Required activities by Responsible Parties, Timing for update and maintenance of registration records

CTGov-005  Results Reporting

CTGov-006  Program Administration and Compliance
Information on: Local PRS processes, Potential consequences for failure to maintain/update records

Additional Resources
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