Protect Your Funding, Publications, and Research Impact
ClinicalTrials.gov registration and results reporting are essential components of modern clinical research. Meeting these requirements helps ensure transparency, supports public trust in research, and protects your study's eligibility for publication, funding, and regulatory compliance.
Case CCC’s CRO provides centralized support to investigators conducting cancer-related research who need to register studies and report results through ClinicalTrials.gov. Our goal is to help investigators navigate complex requirements, avoid compliance risks, and reduce administrative burden throughout the life of a study. For assistance, contact ctgov@case.edu.
Why ClinicalTrials.gov Matters
Timely registration and results reporting help investigators:
- Meet NIH, FDA, and NCI requirements
- Maintain eligibility for publication in leading medical journals
- Improve transparency and public trust in clinical research
- Increase the visibility and impact of research findings
- Avoid compliance findings, funding risks, and reporting delays
- Ensure study results are accessible to patients, researchers, and healthcare professionals worldwide
How We Support Investigators
The CRO provides guidance and support for:
- Study registration and record creation
- Results reporting and submission
- Compliance with FDA, NIH, and ICMJE requirements
- Study updates and record maintenance
- Troubleshooting and issue resolution
- Education and training related to ClinicalTrials.gov requirements
While the Principal Investigator remains responsible for the accuracy of study information, our team works closely with investigators and study staff to facilitate successful registration and reporting.
What Is ClinicalTrials.gov?
ClinicalTrials.gov is a publicly accessible database maintained by the National Library of Medicine at the National Institutes of Health in collaboration with the U.S. Food and Drug Administration.
The database provides patients, caregivers, healthcare professionals, researchers, and the public with information about ongoing and completed clinical studies, helping improve access to research opportunities and study results.
Registration Requirements
Most interventional clinical trials must be registered before or shortly after participant enrollment begins. Registration may be required under:
FDAAA 801 and the Final Rule
Applicable Clinical Trials (ACTs) generally must be registered within 21 days of enrollment of the first participant and report results within 12 months of the study's Primary Completion Date and Study Completion Date.
NIH Dissemination Policy
All NIH-funded interventional clinical trials initiated under applications submitted on or after January 18, 2017, require registration and results reporting, regardless of study phase or intervention type.
International Committee of Medical Journal Editors (ICMJE)
Many leading biomedical journals require clinical trial registration as a condition of publication. Studies enrolling participants on or after January 1, 2019, must also include a data sharing plan in their registration record.
Results Reporting Requirements
Results reporting requirements vary based on study type and funding source but generally include submission of:
- Participant flow information
- Baseline characteristics
- Primary outcome measures
- Secondary outcome measures
- Adverse event and mortality data
In most cases, results are due within one year of the Primary Completion Date, with additional reporting requirements tied to secondary outcomes and final study completion.
The Clinical Research Office can help investigators understand applicable requirements and reporting timelines.
Investigator Responsibilities
The Principal Investigator is ultimately responsible for ensuring that all information submitted to ClinicalTrials.gov is accurate, complete, and submitted on time.
The CRO provides centralized support throughout the process, but investigators must review, verify, and provide required study information in a timely manner.
Why Compliance Matters
Failure to comply with ClinicalTrials.gov requirements may result in:
- Loss of eligibility for publication in participating journals
- Delays or restrictions in NIH or other federal funding
- Institutional compliance findings
- FDA enforcement actions and monetary penalties
- Reduced public visibility of research findings
Our goal is to help investigators meet these requirements efficiently so they can focus on advancing cancer research and improving patient outcomes.
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.