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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

Penalties Regarding Failure to Register or Submit Results