Public disclosure of information about clinical research studies and their results promotes scientific and ethical principles of transparency and accountability. The Clinical Research Office (CRO) provides a centralized support service to investigators at the Case Comprehensive Cancer Center who need to submit information to the ClinicalTrials.gov registry and results databank for investigator-initiated trials that involve cancer research. For more information, contact caseccc-cro@case.edu.
What is ClinicalTrials.gov (CTgov)?
CTgov is a database registry maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH), developed in collaboration with the Food and Drug Administration (FDA). Its purpose is to provide patients, their family members, healthcare professionals, researchers, and the public with easy access to information about publicly and privately supported clinical research on a range of diseases and conditions.
Why register your study?
All Interventional* trials must be registered in CTgov before any participants are enrolled. This business rule ensures compliance with the United States Food and Drug Administration (FDA), National Institutes of Health (NIH), and the publication requirements of the International Committee of Medical Journal Editors (ICMJE).
- FDAAA 801 and the Final Rule: Studies initiated on or after January 18, 2017 and meet the definition of an applicable clinical trial are required to be registered within 21 days after the first participant is enrolled and results are required to be reported within 12 months of the primary completion date (PCD) and study completion date (SCD).
- NIH dissemination policy: Effective January 18, 2017, all interventional studies that are funded in whole or in part by NIH require registration within 21 days after enrollment of the first participant and results reporting within 12 months of the PCD and SCD.
- ICMJE: Requires registration of clinical trials in a public registry as a condition for publication at or before the time of the first participant enrollment. All registrations that began enrolling on or after January 1, 2019 must include a data sharing plan in the trial's registration.
What are the results reporting requirements?
Scope
- Applicable clinical trials (ACTs), which generally include interventional studies of drugs, biological products, or devices that are subject to FDA regulation (excludes phase I and device feasibility studies).
- All NIH-funded clinical trials (regardless of study phase or intervention type) whose funding application was submitted on or after January 18, 2017.
Deadlines
Due within 1 year of primary completion date (PCD):
- Participant flow, baseline characteristics, primary outcomes, secondary outcomes collected on/before PCD, adverse events/mortality (all available at this time)
- Primary Completion Date (PCD) is defined as the date that the final participant was examined or received an intervention for purposes of final collection of primary outcome data
Due within 1 year of each additional outcome measure not reported with the Primary Completion Date (PCD):
- Secondary outcome measure data
- One year after the final subject is examined or received an intervention for purposes of final collection of the secondary outcome measure.
Due within 1 year of study completion date (SCD):
- Remaining adverse events/mortality
- Study Completion Date (SCD) is defined as the final data collection date for study
What is the Principal Investigator's role in ensuring accurate CTgov information?
The Principal Investigator is ultimately responsible for ensuring that the accuracy of information entered in CTgov. The Clinical Research Office offers a centralized registration and results reporting support service but information must be provided and verified by the Principal Investigator in a timely manner.
Failure to comply with FDAAA, NIH, and ICMJE mandates may result in civil monetary penalties, criminal proceedings, loss of HHS funding to study and/or institution, loss of NIH funding, and/or refusal to publish in ICMJE member journal.
Frequently Asked Questions
In interventional studies, participants assigned interventions including drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available to evaluate the effect on biomedical or other health-related outcomes. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise (Reference: https://clinicaltrials.gov/ct2/about-studies/glossary)
NCT number is assigned after CTgov reviews and approves the study submission. Timeline is dependent on communication with Principal Investigator and CTgov reviewer comments (registration is initiated by Clinical Research Office between PRMC approval and IRB approval).
The OnCore Clinical Trials Management System (OnCore) only contains participant accrual information but no outcome measure data.
Yes. All studies that require results must abide by reporting requirements regardless of study status whether the clinical study concluded according to the pre-specified protocol or was terminated.
Yes. The Principal Investigator has the responsibility to fulfill all reporting requirements in CTgov.
Yes. See above Principal Investigator responsibilities.
Amendments are updated in CTgov within 30 days of IRB approval. If you believe your record has not been updated, please contact the Clinical Research Office office at caseccc-cro@case.edu.
No, but the publication can be added as a reference.
Additional Resources
ClinicalTrials.gov
Database of privately and publicly funded clinical studies
Trial reporting in ClinicalTrials.gov - The Final Rule
Zarin D, 2016, N Engl J Med
Glossary of Common Site Terms
Clinical trial registration and results information submission requirements described in Section 801 of the Food and Drug Administration Amendments Act of 2007, known as FDAAA 801.