Clinical Research Quality
Clinical Trials Disclosure (ClinicalTrials.gov)
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?||
|Who is responsible for ClinicalTrials.gov activities?|
|What are the due dates for registration, updates, and results reporting?
What do publishers require?
|How do I register my study?||
|How do I plan for and submit results?||
|When would I upload a blank informed consent form (ICF)?||
|How do I create a dissemination plan?
(NIH-funded clinical trials)
*ICMJE: International Committee of Medical Journal Editors
- Applicable Clinical Trial (ACT) determination
- Results Reporting
- Research current and past clinical trials on the ClinicalTrials.gov public site
- 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
- ICMJE (publishers)
- 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
- 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]
To enter information in ClinicalTrials.gov, log in to the Protocol Registration & Results System (PRS)
- Organization: StanfordU
- Request CTgov support services (new user account, study record access, etc.)
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: