What it is
E-Source and the electronic Trial Master File (e-TMF) manage trial documentation in a centralized, audit-ready repository. E-Source links source documentation to clinical data; e-TMF provides the filing structure, document types, and access control expected for regulatory Trial Master File management.
Who uses it
| Role | Typical use |
|---|---|
| Study Administrator / TMF Manager | Configure document types, filing structure, and access |
| CRA / Monitor | Upload and review site and study-level TMF documents |
| Site staff | File source documents and study correspondence |
| Sponsor | Oversight of TMF completeness and inspection readiness |
Key capabilities
- Configurable TMF document types and folder structure
- Document upload, versioning, and access control
- Integration with source data and CRF attachments
- Audit trail for document lifecycle events