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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. After a record is released by the responsible party in the Protocol Registration and Results System (also called the PRS), the record is reviewed by National Library of Medicine (NLM) reviewers before it is posted on As part of the QC review process, the reviewer provides the responsible party with comments noting Major Issues and Advisory Issues.

This document provides an overview of the ClinicalTrials.gov Protocol Registration Quality Control (QC) review process, along with specific criteria intended to help responsible parties prepare study records with protocol registration information. ClinicalTrials.gov registration information includes 13 modules

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