Certificate In Clinical Data Management
This course provides a comprehensive overview of Clinical Data Management (CDM), covering key processes, tools, and guidelines essential for clinical trials. Students will gain knowledge of CDM roles, data management plans, electronic data capture, database design, data validation, and the integration of AI and ML in virtual clinical trials.
Module 1 : Introduction of Clinical Data Management
- The Clinical Data Management Process
- Objectives of CDM
- Roles involved in CDM
- Introduction to CDM Tools/Softwares
Module 3 : Guidelines for Clinical Data Management
- Documentation Scenario for Data Collection and Management
- International studies and data privacy
- Electronic source data in Clinical Investigations
- Guidance for Industry- ISO, ICH, HL7, CDISC, CDASH
Module 5: Review and Finalization of study documents
- Essential Documents before, during and after the trial_ICH GCP
- Protocol
- Informed Consent Documents
- Investigator’s Brochure
- Case Report Form
- Clinical Study Report
Module 7 : Database designing (CRF and IXRS)
- Purpose of CRF/IXRS
- Regulatory requirements in designing the CRF
- Techniques for Designing CRF/IXRS
- Paper CRF vs. Electronic CRF
Module 9 : CRF Processing & Inventory from site
- CRF Development Process
- Component of CRF
- Data Entry Status
- Discrepancy Status
- Colour coded response fields
Module 11 : Discrepancy Management
- Tools for configuring discrepancy management
- Reasons of discrepancies
- Review status of discrepancies
- Configuring the access status for discrepancies
Module 13 : QA/QC checks in CDM
- Quality Control as per GCP
- Quality Assurance as per GCP
- Audit
- The Quality assurance Group
- Source data Review
- Source data Verification
Module 15 : Tools for CDM
- CDMS- Clinical Data Management Systems
- EDC- Electronic Data Capture
- CTMS- Clinical Trial Management System
- ePRO- Electronic Patient Reported Outcomes
- RTSM- Randomization and Trial Supply Management
Module 2 : Basics of Clinical Trials (Its Stakeholders : Roles and Responsibilities)
- Investigator
- Sponsor
- Contract Research Organization (CRO)
- Clinical Research Coordinator (CRC)
- Clinical Research Associate (CRA)
- Institutional Ethics Committee/IRB
Module 4 : Data Management Plan(DMP)
- Introduction to DMP
- Need of DMP in Clinical Research
- Framework for creating a DMP
- Purpose of DMP
Module 6: Electronic Data Capture
- The Electronic Data Capture (EDC) system
- Verification of EDC setup and implementation
- User Acceptance Testing (UAT)
Module 8 : Data Entry, Data collection & CRF Tracking
- Data entry systems
- Data entry methods
- Data Entry Guidelines
- Data Entry Errors
- Remote Data Entry and its benefits
Module 10 : Data Validation
- CDM requirement in GCP
- Data Validation Process during the conduct of a clinical trial
- Validation steps performed by stakeholders (Investigator, Sponsor, Monitor, CDM team)
Module 12 : Database locking and Unlocking
- Data management Procedure for database lock
- Database lock process
- Unlocking the database lock
- Soft lock/Data cleaning
- Hard lock
Module 14 : Data storage and Archival
- What is data archiving
- The benefit of data archival
- Data archiving and data lifecycle management
- Archiving for regulatory compliance
Module 16 : Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))
- E-Consent (Audio visual consent)
- E-Patient Reported Outcomes (e-PRO)
- IWRS
- Telemedicine
- Patient e Diaries
- Remote Patient Monitoring
Duration : 4hrs / week ( 2 days/week )
Schedule : Session of 2 hours twice a week
Batches Starting From
August 2024
Enroll Now For Early Bird Offers
Duration : 4hrs / week ( 2 days/week )
Schedule : Session of 2 hours twice a week
Perks Of Offline Course
Role Play
Get to work on live projects
Face-to-face guidance by PM (Project Manager)
Clinical on-site exposure