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103.25 Organization Policy on Registration of Clinical Trials
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:
- ICMJE journals will consider [for publication] trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled ("prospective registration"). http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
3. Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS):
- The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1 https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1344.pdf
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).
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:
- ICMJE requires trial registry at or before first patient enrollment as a condition for publication
- The Food and Drug Administration Amendments Act (FDAAA) requires that the Responsible Party for an Applicable Clinical Trial must submit required clinical trial information through the Protocol Registration and Reporting System (PRS) no later than 21 days after enrollment of the first participant.
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 (firstname.lastname@example.org)
- 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:
|Initial estimate of completion date||Time of Registration||11.64, 11.66|
|Update the estimated completion date||at least once every 12 months||11.64, 11.66|
|Changes to the estimated completion date||not later than 30 calendar days after the clinical trial reaches its completion date||11.64, 11.66|
|Initial||Time of Registration||11.64, 11.66|
|Changes||30 days of the change||11.64, 11.66|
|Initial||no later than 1 year after the Primary Completion Date||11.44, 11.48, 11.66|
|Initial||Time of Registration||11.10, 11.66|
|Changes to Device approval status||within15 calendar days||11.66|
Correct errors, deficiencies, and/or inconsistencies
|Registration||15 calendar days after being informed of them by the Agency||11.35, 11.52, 11.66|
|Results||25 calendar days after being informed of them by the Agency||11.35, 11.52, 11.66|
|Duration of Study||1 year regardless of whether there are any changes||11.64, 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 email@example.com.
For further information, please see the guidance on registration of clinical trials at: http://irb.jhmi.edu/Guidelines/clinicaltrials.html