DATA MANAGEMENT
- Protocol development/review support.
- e-CRF design / e-PRO design (Web or Mobile Application)
- Paper CRF design and printing CRF completion guidelines
- Development of project documentation: Data Management Plan, Data Entry Conventions
- Data Cleaning/Validation Plan, Data Management Report.
- Generation of annotated CRFs following sponsor/Anvi & Gnanvi standards
- Database design and set-up
- Database validation with dummy patients
- Data extraction, mapping, and pooling
- CRF tracking
- Data entry (double or interactive mode)
- Data cleaning: programming checks and testing, query management
- Medical preferred term coding (MedDRA, WHOdrug)
- Release of patient profiles and listings
- Conducting medical reviews
- Data quality control
- External data uploading (ECG, CT-Scan, MRI, lab results, drug concentrations, PK data, etc.)
- SAE reconciliation between the safety database and the clinical database.
- Regular reporting: metrics, study status
- Randomization list management
- Participation in the data/blind review meeting
- Database lock (interim and final lock)
- Data transfers
- DM study file maintenance and archiving
