Clinical Data Management Curriculum1) 2) 3) Introduction to Clinical Trials Overview of CDM process DMP (Data Management plan) Concepts

s Contents Guidelines ICH GCP 21 CFR Part 11 Regulatory bodies-FDA, IRB etc CRF Design and development Concepts Best practices Examples Training on CRF Use for site personnel CRF Annotations Concepts Examples Exercises Edit check document preparation for a Protocol Concepts and Types of checks Few Examples Exercise Data Entry Guidelines Process

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Data Cleaning (Data Validation) Login Concepts Browse mode, Update mode Discrepancy Data base Discrepancy management Discrepancy types Review status Resolution status System status Comment window Single record view Multi record view Managing Data Clarification form Dcf generation Dcf sending Dcf Tracking and closing Group update Group Insert Group Marking Examples Exercise 10) Working on MS-excel Data reconciliation and Manual checks Finding discrepancies for Manual checks Data reconciliation Filters Examples

11) Batch Validation- Brief Intro 12) Medical coding 13) SAE Reconciliation 14) Pre QC Check list 15) QC process 16) Data Transfer 17) QA 18) Pre Lock Activities 19) Lock/Freeze 20) Analysis 21) CSR-Clinical study report

Purpose and Importance Auto encoding Dictionaries- WHO Drug, MedRA Terminology Concepts Guidelines Process Examples Exercise