- Design and development of both electronic and paper-based case report forms using CDISC CDASH standards, therapeutic area standards and controlled terminology
- Preparation of CRF completion guidelines
- Data management plan creation
- Generation of the data validation plan (definition of edit checks and checks necessary for medical review)
- Single or double data entry with third party arbitration of discrepancies
- Data cleaning/query management
- Regular quality control through database audits for paper-based studies
- Import of external data
- Medical coding according to MedDRA, WHODrug, ATC
- Preparation of SAE reconciliation Plan
- Serious adverse event reconciliation
- Database lock
- Creation of CDISC SDTM datasets, define-XML v.2.0, reviewer’s guide
- Database delivery in SAS® transport format, Dataset-XML v1.0, or other formats
