Module 1: Introduction to Clinical Data Management and Standards

• Overview of data management in clinical research

• Roles and responsibilities in data management teams

• Key regulations and data standards (ICH-GCP, CDISC, FDA 21 CFR Part 11)

• Hands-on Exercise: Mapping data management workflows for a clinical trial

Module 2: Clinical Database Design and Electronic Data Capture (EDC)

• Components and structure of a clinical database

• Principles of EDC systems and case report form (CRF) design

• Data validation rules and user access control

• Hands-on Exercise: Designing a CRF using an EDC simulation platform

Module 3: Data Collection, Entry, and Quality Control

• Data collection techniques and remote data entry

• Data cleaning, query management, and discrepancy resolution

• Quality control measures and audit trails

• Hands-on Exercise: Conducting a mock data cleaning and validation process

Module 4: Coding and Standardization of Clinical Data

• Coding systems (MedDRA, WHO Drug Dictionary, ICD-10)

• Data harmonization and interoperability

• Metadata management and controlled terminologies

• Hands-on Exercise: Coding adverse events using MedDRA

Module 5: Data Validation and Quality Assurance Procedures

• Designing and implementing a data validation plan

• Statistical data verification and consistency checks

• Internal and external data audits

• Hands-on Exercise: Building a data validation checklist

Module 6: Data Analysis and Statistical Reporting in Clinical Trials

• Overview of biostatistical concepts for data management

• Descriptive and inferential statistics for clinical data

• Generating statistical tables, listings, and figures (TLFs)

• Hands-on Exercise: Creating a mock TLF report using sample datasets

Module 7: Regulatory Requirements for Data Submission

• Data submission formats and guidelines (eCTD, SDTM, ADaM)

• Documentation for regulatory bodies (FDA, EMA, WHO)

• Common submission challenges and solutions

• Hands-on Exercise: Preparing a mock dataset for regulatory submission

Module 8: Data Security, Privacy, and Ethical Considerations

• Ensuring compliance with GDPR, HIPAA, and data protection standards

• Risk management in data storage and transfer

• Data retention, encryption, and confidentiality protocols

• Hands-on Exercise: Conducting a data security and privacy audit

Module 9: Clinical Data Reporting and Visualization

• Principles of data storytelling and report structuring

• Tools for data visualization and dashboards (Tableau, Power BI)

• Reporting templates for study endpoints and KPIs

• Hands-on Exercise: Designing a visual dashboard for clinical metrics

Module 10: Case Study – End-to-End Data Management in a Clinical Trial

• Integrating data management, validation, and reporting practices

• Reviewing real-world data management challenges and resolutions

• Group case presentation and feedback

• Hands-on Exercise: Developing a full data management plan (DMP) for a sample study