COURSE DESCRIPTION
Principles of good data management, case record form design, data management process, data management tools; data validation techniques
Prerequisites
Graduate in Bachelor degree in Health sciences, computer sciences, and ICT
Course Objectives
1. Describe principles of good data management practices
2. Design appropriate case record form for effective data collection
3. Discuss data management processes in clinical research
4. Apply appropriate data management tools to assist clinical data management
5. Use data validation and data handling techniques to appropriately prepare data for analysis
Course Features
- Lectures 58
- Quizzes 2
- Duration 30 hours
- Skill level All levels
- Language English
- Students 34
- Certificate No
- Assessments Yes
-
Week 1: Principle of Clinical Data Management
- Course Overview
- Course Syllabus
- Weekly Activities
- Introduction to Clinical Data Management
- Data Collection Strategies
- Topic Discussion : Data Collection Strategies
- Data Management Process: Project initiation
- Data Management Process: Project Implementation
- Data Management Process: Project Closure
- Reading Assignment : Good data and record management
- Topic Discussion : Data Management Process
- Quiz Week 1 Principle of Clinical Data Management
- Weekly Assignment : Principle of Clinical Data Management
- Course Evaluation
-
Week 2: Good Clinical Data Management Practice (GCDMP)
- Weekly Activities
- GCDMP-Data Collection
- GCDMP-Data Aquisition
- GCDMP-Database Setup
- GCDMP-Data Entry
- GCDMP-Data Quality
- GCDMP-Data Preparation
- Topic Discussion : Good Clinical Data Management Practice (GCDMP)
- Clinical Data Standards (CDISC)
- Additional resource : Clinical Data Standards (CDISC)
- Topic Discussion : Clinical Data Standards (CDISC)
- Case Report Form (CRF) Design
- Topic Discussion : CRF design
- Quiz : Week 2
- Weekly Assignment (Student Project)
- Weekly Assignment 2 (Peer review) : (GCDMP)
- Course Evaluation
-
Week 3-4 : Clinical Data Management System (CDMS)
- Weekly Activities
- Weekly Assignment :CDMS (Student Project)
- Introduction to Clinical Data Management System (CDMS)
- Database Design
- OpenClinica Installation
- Getting Started with OpenClinica
- Create New Users
- Create New Study
- Database Setup
- Assign Study sites and Users
- Data Entry
- Data extraction
- Reading Assignment
- Course Evaluation
-
Week 5: Mobile Data Collection Tools
-
Week 6: Data Preparation for Analysis
