Protocol and SAP analysis is the most crucial stage of clinical data management. By assisting the development and thorough analysis of the study protocol, the Study Architect extracts the blueprint of the study, and organizes it using a Protocol Representation Model (PRM). The information is used by all downstream stages, including CRF development, to Electronic Data Capture (EDC) system, statistical analysis, reporting, and study writing.
The following components are managed by Study Architect:
- Registration: study summary information
- Eligibility Criteria: subject identification and recruitment
- Trial Design: investigational plan and treatment
- Scheduled Events: scheduling of treatment and assessments, used to drive data collection
- Analysis Plan (extended): endpoints and statistical methods