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Clinical Database Management(18BT2038), Monitoring - Coggle Diagram
Clinical Database Management(18BT2038)
INTRODUCTION OF CLINICAL TRIALS
Basic statistics for clinical trials
Roles & Responsibilities of Key Stakeholders
Preparations & Planning for Clinical Trials
Essential Documentation in Clinical Research & Regulatory Submissions
Clinical Trials Project Planning & Management
Clinical Trials Project Planning & Management
Clinical Monitoring Essentials
CLINICAL DATA MANAGEMENT
, Study Set Up
CRF Design Considerations
Data Definition & Types
Data Entry, Remote Data Entry
Introduction to Data Management
Identifying and Managing Discrepancies
Medical Coding, Database Closure
Data Management Plan, Electronic Data Capture
Tracking CRF Data
Managing Lab Data, Collecting Adverse Event Data
Creating Reports and Transferring Data
Enterprise Clinical Data Management Tools
CLINICAL DATA ANALYSIS AND MANAGEMENT
Documents, guidelines used in CDM
Data Entry, Data Review/Data Validation
Introduction to Clinical Database
Query Management, Data management plan
Study set-up
Project management for the clinical data manager
Vendor selection and management, Data management standards in clinical research
Design and development of data collection
Edit check design principles
CLINICAL CASE REPORT FORMS
Laboratory data handling
External data transfer
, programming and standards
Data validation
Patient –reported outcomes
CRF printing and vendor selection
CDM presentation at investigator meetings
CRF Completion Guidelines
Metrics for clinical trials
Systems Software Validation Issues Clinical Trials Database Environment
CLINICAL QUALITY AUDIT
types & procedures
Audit standards
Audit trail & its role in authenticity of data
Audit plan
Audit –Definition
Audit by regulatory authorities
regulatory authorities
CLINICAL LOGISTICS AND REGULATIONS
What makes a good audit
Preparing and delivering audit reports
GDP & logistics
CLINICAL LOGISTICS AND REGULATIONS
New product development
GxP Regulations
Monitoring
Compliance
Auditing & Quality Control in Clinical Research