Clinical Research Support
Quality Assurance Office for Clinical Trials (QACT)
Clinical Trial Registration
Clinical Trials Registration
The information outlined below is intended to help DF/HCC investigators understand the requirements for clinical trial registration, their responsibilities for clinical trial registration, and how to register and manage clinical trials on the clinicaltrials.gov website.
Determine If Your Clinical Trial Is Required To Be Registered
Food and Drug Administration (FDA) Registration Requirements
International Committee of Medical Journal Editors (ICMJE) Registration Requirements
DF/HCC SOPs for ClinicalTrials.gov Registration and Record Management
- REGIST 200: Registration of Clinical Trials on ClinicalTrials.gov
- REGIST 201: Posting Results and Adverse Events on ClinicalTrials.gov
Failure to Register or Report Results
Guidance for ClinicalTrials.gov Registration and Management
When/How to Register a Protocol on ClinicalTrials.gov (overview)
Step by Step Guidance for Registering a Protocol on ClinicalTrials.gov
How to Determine Primary Completion and Study Completion Date
When/How to Update a ClinicalTrials.gov Record
When/How to Submit Results to ClinicalTrials.gov
Common Mistakes Found Within ClinicalTrials.gov Records
DF/HCC Contacts for ClinicalTrials.gov Accounts and Initial Registration
Additional Information
Food and Drug Administration (FDA) Information Page
Food and Drug Administration Amendments Act (FDAAA) of 2007
National Institutes of Health (NIH) Guidance on New Results Database
ClinicalTrials.gov - NCT Record Registration, Record Management and Results Reporting Information
- Clinical Trials Education Office (CTEO)
- Clinical Investigations Leadership Committee (CLC)
- Clinical Research Unit (CRU)
- Protocol Review and Monitoring System (PRMS)
- OnCore
