Research Quality

On This Page

Questions?

Contact the Stanford CRQ support team

For cancer studies, contact the CCTO Office  

Clinical Trials Disclosure (ClinicalTrials.gov)

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?
Who is responsible for ClinicalTrials.gov activities?
What are the due dates for registration, updates, and results reporting?

What do publishers require?

(ICMJE*)

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

ClinicalTrials.gov Resources

NIH Resources

Other Resources

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

Spectrum Home Page

To enter information in ClinicalTrials.gov, log in to the Protocol Registration & Results System (PRS)

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: