Curriculum
- 4 Sections
- 40 Lessons
- 10 Weeks
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- Module 1: Introduction to topics related to Clinical Data Management1
- Module 2: EDC Setup15
- 2.1Kick-off and various other important meetings
- 2.2Protocol Review
- 2.3CRF Design considerations by SDTM
- 2.4Create Edit check specifications including Dynamic Rules, Mapping and Calculation fields
- 2.5Edit check specification programming
- 2.6Test cases for edit checks
- 2.7Edit checks validation or UAT
- 2.8Online Screen Review Meeting (OSRM)
- 2.9Investigator Meeting (IM)
- 2.10Training the users
- 2.11Setup of standard and custom reports
- 2.12Develop and Maintain study documents
- 2.13Budgeting and Finance
- 2.14Go-Live
- 2.15(Split go-live)
- Module 3: Conduct / Maintenance17
- 3.1Develop and Maintain study documents
- 3.2Programming of manual checks
- 3.3Query Management
- 3.4Vendor, SAE, IVRS data reconciliation
- 3.5Local lab data handling
- 3.6Medical Coding
- 3.7Manual data review
- 3.8Liaise with CRA for SDV, site issues, etc.
- 3.9Status and Metrics
- 3.10Milestones data cleaning approach
- 3.11Clean patient tracking
- 3.12Post production changes
- 3.13Interim Analysis
- 3.14Regular meetings with stakeholders
- 3.15Training new staff
- 3.16User Access Management
- 3.17Quality Control and Audit
- Module 4: Database Lock (DBL)7
