5 pages
Prachi
DMPTemplate.docxGOOD CLINICAL TRIALS - DATA MANAGEMENT PLAN
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Clinical Study to Compare the Efficacy and Safety of XYZ Versus Corticosteroid for the Treatment of Lateral Epicondylitis (LE), Protocol Number ASUCNHI/XYZ-LE/16-17/001
Overview
Data Management Staff Roles and Responsibilities
Data Management Staff Roles and Responsibilities
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Site Policies
Data Access
Data Entry & Cleaning
Monitor Visits
Database Closure Checks
Data Archiving Record Storage and Retention
Adverse and Serious Adverse Events Management & Reconciliation
