ClinicalTrials.gov Support
Protect Your Funding, Publications, and Research Visibility
ClinicalTrials.gov registration and results reporting are required for many clinical studies and play an important role in research transparency, publication eligibility, and regulatory compliance.
Case CCC’s Clinical Research Office (CRO) provides centralized support for investigators conducting cancer-related research, helping study teams navigate registration, reporting, and ongoing compliance requirements. For assistance, contact ctgov@case.edu.
Why It Matters
Timely registration and reporting can help investigators:
- Meet NIH, FDA, NCI, and ICMJE requirements
- Maintain eligibility for publication in leading journals
- Reduce compliance and funding risks
- Increase the visibility and reach of research findings
- Improve public access to clinical research information
How the CRO Supports Investigators
The CRO provides guidance for:
- Study registration and record creation
- Results reporting and submission
- Record updates and maintenance
- FDA, NIH, and ICMJE compliance requirements
- Troubleshooting and training
While the Principal Investigator remains responsible for submitted information, the CRO works closely with investigators and study teams throughout the process.
Registration and Reporting Requirements
Most interventional clinical trials must be registered shortly after enrollment begins and may require results reporting within one year of the study’s Primary Completion Date. Requirements vary based on study type, funding source, and regulatory oversight.
Registration may be required under:
- FDAAA 801 and the Final Rule
- NIH Dissemination Policy
- International Committee of Medical Journal Editors (ICMJE) policies
Many journals also require trial registration before participant enrollment as a condition of publication.
Why Compliance Matters
Failure to comply may result in:
- Loss of publication eligibility
- Delays or restrictions in federal funding
- Institutional compliance findings
- FDA penalties and enforcement actions
The CRO helps investigators manage these requirements efficiently so they can stay focused on conducting impactful cancer research.
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 at ctgov@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.