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Protocol Registration and Document Upload Quality Control ...

Protocol Registration and Document Upload Quality Control review criteria 27 June 2018 Page 1 of 10 Protocol Registration Quality Control review criteria Introduction and Overview This Document provides an overview of the Protocol Registration Quality Control (QC) review process, along with specific criteria intended to help responsible parties prepare study records with Protocol Registration information. Registration information includes 13 modules for describing the study Protocol , including Study Identification, Study Status, Oversight, Study Design, Outcome Measures, Eligibility, and others.

The entries for each data element are consistent with the Protocol Registration Data Element Definitions. ClinicalTrials.gov Protocol Registration and Document Upload Quality Control Review Criteria 27 …

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