Registering and Reporting
Why Register and Report?
- Commitment to research participants
- Scientific validity/transparency
- Ethical standards
- Responsible stewardship of federal funds
- Required by law (FDAAA)
- * NEW* Required for any clinical trial funded in full or in part by NIH
- Required by NCI
- Required for journal publication (ICMJE)
- Required for CMS
- Required by WHO
Who is Responsible for Registering a Trial?
The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be:
The Sponsor of the clinical trial (as defined in section 21 CFR 50.3) who initiates the study. The Johns Hopkins PI should consult with commercial sponsors to assure that posting of a trial is in accord with terms of the study contract.
The Principal Investigator (PI) of such clinical trial, assuming:
- 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.
The Sponsor-Investigator (the individual who both initiates and conducts the study)
For clinical trials being conducted in the Sidney Kimmel Comprehensive Cancer Center, the Oncology Clinical Research Office (CRO) is responsible for clinicaltrials.gov user account set-up. Contact the CRO at 410-955-0350 for registration information.
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:
- 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
- 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/faqsclinical-trials-registration/
- Clinical Trials funded either in whole, or in part by National Institutes of Health (NIH): https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22379.pdf
- “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.
- 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
Trials that are excluded:
- (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 PI should consult with commercial sponsors to assure that posting of a trial is in accord with terms of the study contract.
When Should Studies be Registered?
Clinical trial registration information will be requested with the initial IRB application. If the trial has not been registered at the time of initial IRB approval, the investigator will mark the NCT number as pending. It is the responsibility of the PI to update the IRB application with the NCT number in accordance with the following timeline
- 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.