Data Management in Clinical Research Studies
( 25 Modules )

Module #1
Introduction to Data Management in Clinical Research
Overview of data management principles, importance, and regulations in clinical research

Module #2
Clinical Research Study Design and Data Management Planning
Understanding study design, data management planning, and data flow

Module #3
Data Management Roles and Responsibilities
Understanding roles and responsibilities of data managers, study coordinators, and investigators

Module #4
Data Management Systems and Tools
Overview of electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other data management tools

Module #5
Data Quality and Control
Importance of data quality, data cleaning, and data validation

Module #6
Data Standardization and Normalization
Data standardization, normalization, and data formatting

Module #7
Data Security and Confidentiality
Ensuring data security and confidentiality, access controls, and encryption

Module #8
Regulatory Compliance and Guidelines
Overview of regulatory guidelines, ICH-GCP, and 21 CFR Part 11 compliance

Module #9
Data Management Plans and SOPs
Development and implementation of data management plans and standard operating procedures (SOPs)

Module #10
Data Collection and Capture
Data collection methods, paper-based and electronic data capture (EDC)

Module #11
Data Review and Cleaning
Data review, data cleaning, and data quality control processes

Module #12
Data Validation and Verification
Data validation, data verification, and data integrity checks

Module #13
Data Storage and Backup
Data storage, data backup, and data archiving

Module #14
Data Retrieval and Querying
Data retrieval, data querying, and data reporting

Module #15
Data Analysis and Interpretation
Overview of data analysis, data visualization, and data interpretation

Module #16
Data Integration and Interoperability
Data integration, data interoperability, and data standards

Module #17
Data Management for Specific Therapeutic Areas
Data management considerations for specific therapeutic areas (e.g., oncology, pediatrics)

Module #18
Data Management for Decentralized Clinical Trials
Data management considerations for decentralized clinical trials (DCTs)

Module #19
Data Management for Real-World Evidence (RWE) Studies
Data management considerations for RWE studies

Module #20
Data Management for Adaptive Clinical Trials
Data management considerations for adaptive clinical trials

Module #21
Data Management Metrics and Performance
Data management metrics, key performance indicators (KPIs), and data quality metrics

Module #22
Data Management Audits and Inspections
Preparing for data management audits and inspections, risk-based monitoring

Module #23
Data Management for Multi-Center and Global Clinical Trials
Data management considerations for multi-center and global clinical trials

Module #24
Data Management for Electronic Health Records (EHRs)
Data management considerations for EHRs and electronic medical records (EMRs)

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Data Management in Clinical Research Studies career

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Data Management in Clinical Research Studies ( 25 Modules )

Data Management in Clinical Research Studies
( 25 Modules )