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103.25 Organization Policy on Registration of Clinical Trials

October 2016

What Studies to Register?

It is the policy of the Organization that the following new or ongoing clinical trials shall be registered on http://www.clinicaltrials.gov:

1. Clinical Trials funded either in whole, or in part by National Institutes of Health (NIH)    (applicable to all NIH-funded studies independent of whether the study meets the definition of an applicable clinical trial as detailed below):

2. Trials that meet the clinical trial definition of The International Committee of Medical Journal Editors (ICMJE) that the investigator may wish to publish:

3. Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS):

4. “Applicable Clinical Trials (ACT)” which include the following:

  • Trials of Drugs/Biologics:  Controlled, clinical investigations of a product subject to FDA regulations.  This includes preliminary studies or phase I trials to be published in an ICMJE journal.
  • Trials of Devices:  Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.

Applicable Clinical Trials generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions.

  • The trial has one or more sites in the U.S.
  • The trial is conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) application
  • The trial involves a drug, biologic, or device that is manufactured in the U.S. or its territories and is exported for research

The following trials are generally excluded (unless funded either in whole, or in part by NIH):

  • (Non-serious/life-threatening) Phase 1 drug trials, including studies in which drugs are used as   research tools to explore biological phenomena or disease processes
  • Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
  • Trials that do not include drugs, biologics, or devices (e.g., behavioral interventions)
  • Non-interventional (observational) clinical research, such as cohort or case control studies
  • Trials that were ongoing* as of September 27, 2007, and reached the Completion Date before December 26, 2007

(*An “ongoing” trial has enrolled one or more subjects and the final subject has not been examined or received an intervention for the purpose of collecting data on the primary outcome).

ACT Wizard: http://grants.nih.gov/clinicaltrials_fdaaa/docs/Flow_chart-ACT_only.pdf

The Johns Hopkins Principal Investigator (PI) should consult with commercial sponsors to assure that posting of a trial is in accord with terms of the study contract.  A Sponsor providing drug only generally does not accept the registration and results reporting responsibilities.  Generally for IND or IDE studies, the responsibility rests with the local investigator.

When Should Studies be Registered?

It is the policy of the Organization that registration of trials meeting any of the criteria outlined in this Policy be submitted to ClinicalTrials.gov concurrently with initial IRB submission.  Concurrent submission recognizes that registration is a process which requires review and potential comments prior to public release from the ClinicalTrials.gov PRS Review Team.

The NCT number should be listed on the initial IRB application.  Should the trial be submitted to the IRB with the NCT number “pending” the PI or member of the study team must update the NCT number as soon as the number is assigned by ClinicalTrials.gov.  Updating the NCT number is done through an administrative action and does not require a change in research application. 

It is the responsibility of the PI to register the trial in accordance with the following timelines:

Other Policy Requirements

1.    The IRB number will be used as the “Protocol ID” within CliniicalTrials.gov

2.    If not already designated as the “Record Owner” the PI will be included in the “Access List”

3.   The “Oversight” Section of ClinicalTrials.gov will contain accurate information pertaining to:

  • Status (i.e, request not yet submitted; submitted, pending)
  • Board Name (Johns Hopkins Medicine Institutional Review Board)
  • Board Affiliation (Johns Hopkins Medicine)
  • Board Contact
    • Business Phone (410-955-3008)
    • Business e-mail (jhmeirb@jhmi.edu)
    • Address of IRB [(East Baltimore Campus (Central Office), 1620 McElderry St., Reed Hall - B130, Baltimore, MD 21205-1911)]

4.  All Information in ClinicialTrials.gov will be updated per the following timelines so that the record available to the public is continually up-to-date and accurate: 

Completion Date

PhaseTimelinePolicy reference
Initial estimate of completion dateTime of Registration11.64, 11.66
Update the estimated completion dateat least once every 12 months11.64, 11.66
Changes to the estimated completion datenot later than 30 calendar days after the clinical trial reaches its completion date11.64, 11.66

Recruitment Status

PhaseTimelinePolicy reference
InitialTime of Registration11.64, 11.66
Changes30 days of the change11.64, 11.66

Results Reporting

PhaseTimelinePolicy reference
Initialno later than 1 year after the Primary Completion Date11.44, 11.48, 11.66

IND/IDE Status

PhaseTimelinePolicy reference
InitialTime of Registration11.10, 11.66
Changes to Device approval statuswithin15 calendar days11.66

Correct errors, deficiencies, and/or inconsistencies

PhaseTimelinePolicy reference
Registration15 calendar days after being informed of them by the Agency11.35, 11.52, 11.66
Results25 calendar days after being informed of them by the Agency11.35, 11.52, 11.66

General Updates

PhaseTimelinePolicy reference
Duration of Study 1 year regardless of whether there are any changes11.64, 11.66

Assigning the Responsible Party

It is the policy of the Organization that the “Responsible Party” is designated as the “Sponsor.” This allows for the Johns Hopkins ClinicalTrials.gov Program to review records for common errors prior to being released.

To contact the Johns Hopkins ClinicalTrials.gov program, please e-mail registerclinicaltrials@jhmi.edu.

For further information, please see the guidance on registration of clinical trials at: http://irb.jhmi.edu/Guidelines/clinicaltrials.html