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Frequently Asked Questions about Clinicaltrials.gov Registration and Results Submission for NIMH-funded Clinical Trials

Study Registration

Which studies are expected to register in Clinicaltrials.gov?

Effective January 18, 2017, the NIH Policy on the Dissemination of NIH-funded Clinical Trials establishes the expectation for Clinicaltrials.gov registration of all NIH-funded clinical trials, funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether the trial is subject to FDAAA.  This policy applies to phase 1 clinical trials of FDA-regulated products and small feasibility device trials as well as products that are not regulated by the FDA, such as behavioral interventions.

How do I know if my study is a clinical trial?

NIH defines a clinical trial as a research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5
Additional information about the revised NIH clinical trial definition is available at http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials.  If you are not sure if your study meets the NIH clinical trial definition, contact nimhctobb@mail.nih.gov.

Who is responsible for registering and submitting results for the trial?

The responsible party for a clinical trial must register the trial and submit results information. The responsible party is defined as:

  • The sponsor of the clinical trial or
  • The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of FDAAA's requirements for the submission of clinical trial information

How do I register a trial in Clinicaltrials.gov?

The responsible party enters study registration data in the Protocol Registration and Results System (PRS).   Instructions for registration are available at https://clinicaltrials.gov/ct2/manage-recs/how-register.  Responsible parties are encouraged to review the Clinicaltrials.gov protocol review criteria prior to submitting the registration.

Clinicaltrials.gov staff review registration submissions and may request additional information.  This process typically takes 2-5 days.  Once your trial is successfully registered, the responsible party will receive an email with the trial’s National Clinical Trials (NCT) number and the record will be viewable to the public.

See below for additional instructions that apply to trials based on NIMH funding mechanism:

  • Grants and cooperative agreements
    NIMH-supported grants and cooperative agreements are expected to list NIMH as a study collaborator and include the full NIH grant number.
  • NIMH intramural research program
    NIMH intramural trials should include the intramural protocol number and the Z number, if available.
  • Contracts
    NIMH contracts must be registered in the NIMH PRS account.  Contact the NIMH PRS Administrator at bbowers@mail.nih.gov.

How do I create a PRS account?

Contact your Institution’s PRS administrator.  If you do not know your PRS Administrator, submit a PRS Administrator Contact Request Form.

Organizations without a PRS account will need to create one.  Instructions for creating a PRS account are available at https://clinicaltrials.gov/ct2/manage-recs/how-apply.

Results Reporting

Which studies are expected to report results in Clinicaltrials.gov?

Effective January 18, 2017, all NIH-funded studies expected to register in Clinicaltrials.gov are also expected to report results.  As mentioned above, the NIH Policy on the Dissemination of NIH-funded Clinical Trials applies to all NIH-funded clinical trials, funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether the trial is subject to FDAAA.  This policy applies to phase 1 clinical trials of FDA-regulated products and small feasibility device trials as well as products that are not regulated by the FDA, such as behavioral interventions.

How do I report results?

Instructions for reporting results are available at https://clinicaltrials.gov/ct2/manage-recs/how-report.  Responsible parties are encouraged to review the Clinicaltrials.gov results review criteria prior to submitting results.

When am I required to report results?

No later than one year after the trial’s primary completion date, defined as the date on which the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected.

What results information is required?

Scientific results information is submitted as four separate modules:  Participant Flow, Baseline Characteristics, Outcome Measures and Statistical Analyses, and Adverse Events.  Administrative information on certain disclosure agreements and points of contact is also required.  Information is submitted in a summary tabular format as required by FDAAA; individual-level participant data are not collected.  A list of basic data elements and their definitions is available at https://prsinfo.clinicaltrials.gov/results_definitions.html.

General FAQ

How often should I update my study record?

Your study record should be updated at least every 12 months, or within 30 calendar days of a change to protocol information, including recruitment status or primary completion date. 

Whom can I contact for help?

You may contact nimhctobb@mail.nih.gov with questions about registration and results reporting requirements for NIMH-funded studies. For questions regarding NIMH contract registration you may contact the NIMH PRS Administrator at bbowers@mail.nih.gov. For assistance with the Protocol Registration and Results System (PRS), contact register@clinicaltrials.gov.

Where can I find additional information?

Additional information about Clinicaltrials.gov registration and results submission, including training materials and FAQS, is available at https://clinicaltrials.gov/ct2/manage-recs.

References

1 See Common Rule definition of research at 45 CFR 46.102(d).

2 See Common Rule definition of human subject at 45 CFR 46.102(f).

3 The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4 An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5 Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.