临床数据管理 (Cdm) - 终极概述
- 1 - Introduction
- 1 - Introduction
- 2 - Download the course materials
- 2 - The Basics of Clinical Data Management
- 3 - What is Clinical Data Management CDM
- 4 - What is a Clinical Trial
- 5 - What is Clinical Research
- 6 - Importance of data integrity quality and compliance in clinical trials
- 7 - Objectives of Clinical Data Management CDM
- 8 - Roles in Clinical Data Management
- 9 - Glossary of related terms Part 1 40 important terms to know
- 10 - Glossary of related terms Part 2 40 important terms to know
- 11 - Glossary of related terms Part 3 40 important terms to know
- 3 - Regulatory Framework and Ethical Considerations
- 12 - Overview of Clinical Trial regulations
- 13 - Ethical data considerations in clinical trials
- 14 - Understanding the role of Institutional Review Boards IRBs
- 4 - Clinical Data Management Planning Phase
- 15 - Clinical Trial Protocol
- 16 - Developing a Clinical Data Management Plan CDMP
- 17 - Designing case report forms CRFs
- 5 - Clinical Data Management Data Collection Entry Phase
- 18 - Informed Consent Forms template reviewed included in lesson
- 19 - Data collection methods
- 20 - Electronic Data Capture EDC Systems
- 6 - Clinical Data Management Data Cleaning and Validation Phase
- 21 - Key Steps in Data Cleaning and Validation for Clinical Data Management
- 22 - PreEntry data validation
- 23 - OnEntry data validation
- 24 - PostEntry data validation
- 25 - Documentation of Data Cleaning Activities
- 26 - Regular Data Reviews
- 27 - Query Management in CDM OpenClinica example
- 7 - Clinical Data Management Data Integration and Analysis Phase
- 28 - Database Locking Procedures
- 29 - Statistical Analysis Plan SAP
- 8 - Clinical Data Management Reporting Phase
- 30 - Clinical Study Report CSR
- 9 - Clinical Data Management PostSubmission Phase
- 31 - PostMarket Surveillance
- 10 - Current Trends and Technologies in CDM
- 32 - Innovations in Clinical Data Management
- 33 - Future directions in clinical data management practices
- 11 - Optional Section Data Quality
- 34 - Why learn more about Data Quality to improve your CDM
- 35 - Intro to Data Quality
- 36 - The Data Quality Dimensions
- 37 - Data Accuracy
- 38 - Data Validity
- 39 - Data Timeliness
- 40 - Data Completeness
- 41 - Data Uniqueness
- 42 - Data Consistency
- 43 - What are Data Quality rules
- 44 - Steps to Implement Data Quality rules
- 45 - Implementing data quality rules
- 46 - Implementing data quality rules part 2
- 13 - Course Closure
- 47 - Next Steps
- 48 - Thank You