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CRQ ClinicalTrials.gov Support Services

Clinical Research Quality (CRQ) provides support to Stanford investigators and staff who need to submit information to the ClinicalTrials.gov registry and results databank.

CRQ ClinicalTrials.gov Support Resources

Determine registration and results reporting requirements:
Most requirements apply to clinical trials

Stanford decision tree

See the NIH Clinical Trial Definition Case Studies

Determine who is responsible for ClinicalTrials.gov activities:

Stanford guidelines

School of Medicine Policy

Understand when initial registration, updates, and results are expected:

ClinicalTrials.gov Reporting Due Dates

Publishers require registration prior to enrollment of any participant; they also expect a data sharing statement to be included in the registration.

ICMJE policy

(ICMJE: International Committee of Medical Journal Editors)

Understanding Data Sharing Statements

Speed your entry and avoid ClinicalTrials.gov QC Review comments.

Stanford Registration Quick Guide

Includes definitions, tips, and Stanford-specific information

Results resources: use them to plan ahead, and at the time of results submission.

Summary of Results Information Required by ClinicalTrials.gov

ClinicalTrials.gov Results Checklist

For most federally funded trials, a copy of the blank ICF must be posted any time after the trial is closed to recruitment, but no later than 60 days after the last study visit by any subject.

ICF Disclosure under the Common Rule

Includes specific instructions for when and how to post a blank ICF to ClinicalTrials.gov (or Regulations.gov)

How to create study documents that can be uploaded to ClinicalTrials.gov

Preparation and Submission of Study Documents to ClinicalTrials.gov

Study documents cover page template

How to create a dissemination plan (required in grant applications for NIH-funded clinical trials).

NIH dissemination plan