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Clinical Trials Disclosure (ClinicalTrials.gov)
What's new?
In response to the current COVID-19 pandemic, the Clinical Trials Registration and Results Reporting Taskforce, a national consortium of members of academic medical centers, universities, hospitals, and non-profit organizations, released the following resource:
Suggested Best Practices for ClinicalTrials.gov Activity during the COVID-19 Pandemic
Overview
Disclosure of clinical trial information promotes scientific and ethical principles of transparency and accountability in clinical research.
Clinical Research Quality (CRQ) provides support to Stanford investigators and staff who need to submit information to the ClinicalTrials.gov registry and results databank.
Stanford CRQ Resources
| Is registration and/or results reporting required? |
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| Who is responsible for ClinicalTrials.gov activities? |
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| What are the due dates for registration, updates, and results reporting? |
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What do publishers require? (ICMJE*) |
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| How do I register my study? |
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| How do I plan for and submit results? |
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| When would I upload a blank informed consent form (ICF)? |
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| How do I create a dissemination plan? (NIH-funded clinical trials) |
*ICMJE: International Committee of Medical Journal Editors
ClinicalTrials.gov Resources
- Applicable Clinical Trial (ACT) determination
- ACT Checklist
- ACT FAQs
- Registration
- Results Reporting
- Research current and past clinical trials on the ClinicalTrials.gov public site
NIH Resources
- Resources for determining if a study is a clinical trial:
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov
Other Resources
- ICMJE (publishers)
- Clinical trial recommendations and FAQs
- Press release on data sharing statements
- Patient Centered Outcomes Research Institute (PCORI)
- PCORI Process for Peer Review of Primary Research and Public Release of Research Findings (with summary of PCORI registration and results reporting requirements)
- Center for Medicare and Medicaid Services (CMS)
- See ClinicalTrials.gov help on CMS billing requirements
References
- Clinical Trials Registration and Results Information Submission - 42 CFR 11
- Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA; 2016. DOI:10.1001/jama.2016.14668. [Full Text]
- Zarin DA, An Audience with Deborah Zarin. Nature Reviews Drug Discovery. DOI:10.1038/nrd.2016.215. [Full Text]
- Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov - the final rule. N Engl J Med; 2016. DOI:10.1056/NEJMsr1611785. [Full Text]
Quicklinks
To enter information in ClinicalTrials.gov, log in to the Protocol Registration & Results System (PRS)
- Organization: StanfordU
- Request PRS account/study record access
When is a study a clinical trial? See:
Administrator Group (AG) Resources
The Administrators Group consists of research staff supporting investigators at the department or center level. Contact CRQ for more information.
For AG Members: