Data Management
Study Start-up
User Acceptance Testing
Data Validation Plan
- Online (Real Time, Batch): Integrated with EDC
- Offline (SAS)
EDC User Training
Data Management Plan
External Data Integration
- Data Transfer Specification
- Central Lab
- ECG Core Lab
- Pharmacokinetic/Pharmacodynamic Data
- IxRS Data
- CTMS Data
- ePRO
- Devices
Study Conduct
Data Review/Cleaning
- Data Tables, Listings and Figures
Patient Profile
DSMB Support
External Data Reconciliation
SAE Reconciliations
Medical Coding
- MedDRA
- WHO Drug
Data Standard
- CDISC SDTM Mapping Annotation (aCRF)
- CDISC SDTM Mapping Programming
- CDISC SDTM Define.xml
- CDISC SDTM Reviewer’s Guide
- Sponsor Specific Standards
Study Closeout
Database Lock
- Multiple DB Lock Support
- Adaptive Study Designs
- Interim Analyses
- Final Lock
- Clean File Meeting
- Data Lock Documentation