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 59
- Quizzes 2
- Duration 30 hours
- Skill level All levels
- Language English
- Students 78
- Certificate No
- Assessments Yes
Curriculum
- 5 Sections
- 59 Lessons
- 10 Weeks
Expand all sectionsCollapse all sections
- Week 1: Principle of Clinical Data Management15
- 2.1Course Overview
- 2.2Course Syllabus
- 2.3Weekly Activities
- 2.4Data Governance in Clinical Research
- 2.5Data Collection Strategies
- 2.6Topic Discussion 1.1: Data Collection Strategies
- 2.7Data Management Process: Project Initiation
- 2.8Data Management Process: Project Implementation
- 2.9Data Management Process: Project Closure
- 2.10Reading Assignment : Good Data and Record Management
- 2.11Topic Discussion 1.2: Data Management Process
- 2.12Quiz Week 1 Principle of Clinical Data Management45 Minutes10 Questions
- 2.13Introduction to Project Assignment
- 2.14Weekly Assignment 1: Principle of Clinical Data Management
- 2.15Course Evaluation
- Week 2: Good Clinical Data Management Practice (GCDMP)17
- 3.1Weekly Activities
- 3.2GCDMP-Data Collection
- 3.3GCDMP-Data Aquisition
- 3.4GCDMP-Database Setup
- 3.5GCDMP-Data Entry
- 3.6GCDMP-Data Quality
- 3.7GCDMP-Data Preparation
- 3.8Topic Discussion 2.1: Good Clinical Data Management Practice (GCDMP)
- 3.9Clinical Data Standards (CDISC)
- 3.10Additional resource: Clinical Data Standards (CDISC)
- 3.11Topic Discussion 2.2: Clinical Data Standards (CDISC)
- 3.12Case Report Form (CRF) Design
- 3.13Topic Discussion 2.3: CRF design
- 3.14Quiz : Week 245 Minutes10 Questions
- 3.15Weekly Assignment 2 (Student Project)
- 3.16Weekly Assignment 2 (Peer review): (GCDMP)
- 3.17Course Evaluation
- Week 3-4 : Clinical Data Management System (CDMS)14
- 4.1Weekly Activities
- 4.2Weekly Assignment 3-4: CDMS (Student Project)
- 4.3Introduction to Clinical Data Management System (CDMS)
- 4.4Database Design
- 4.5OpenClinica Installation
- 4.6Getting Started with OpenClinica
- 4.7Create New Users
- 4.8Create New Study
- 4.9Database Setup
- 4.10Assign Study sites and Users
- 4.11Data Entry
- 4.12Data extraction
- 4.13Reading Assignment
- 4.14Course Evaluation
- Week 5: Mobile Data Collection Tools9
- Week 6: Data Preparation for Analysis11
- 6.1Weekly Activities
- 6.2Practice datasets
- 6.3Combining different data files
- 6.4Restructure data files
- 6.5Handling duplicate records
- 6.6Handling missing data
- 6.7Data transformation
- 6.8Handling variables
- 6.9Reading Materials : Data Preparation for Analysis
- 6.10Weekly Assignment 6 : Data Preparation for Analysis
- 6.11Course Evaluation
