Yes. Castor CDMS is built and validated in full accordance with ICH-GCP (E6 R2) guidelines, providing the technical infrastructure and data integrity controls you need to run a fully compliant trial.
Note: While Castor provides the compliant electronic system, overall trial GCP compliance remains a shared responsibility between the system vendor, the sponsor, and the principal investigator (enforcing trial SOPs, protocol adherence, and staff delegation).
How Castor Supports ICH-GCP (Section 5.5.3 - Electronic Trial Data)
1. Audit Trail & Data Integrity (ALCOA+)
- Automatic Audit Trail: Every data entry, edit, or deletion is automatically stamped with the user ID, date, and time. Previous values are permanently retained.
- Mandatory Reason for Change: Study admins can enforce a mandatory reason for change whenever previously saved clinical data is modified: Enabling GCP Reason for Change in CDMS.
- Attributable Signatures: Investigators can electronically sign completed forms, visits, and participant records with legal non-repudiation.
2. Access Control & Authorization Lists
- Role-Based Access (RBAC): Restrict data entry, verification, and signing rights strictly according to site delegation logs.
- User Tracking: Clear audit logging of which users are invited, active, or revoked.
- Blinding Protection: Field- and form-level blinding permissions prevent investigators or participants from viewing unblinded trial data.
3. Clinical Monitoring & Source Data Verification (SDV)
- Query Management: Built-in query workflows allow Clinical Research Associates (CRAs) and data managers to open, track, and resolve data discrepancies directly in the eCRF.
- Record Locking: Freeze or lock completed records to prevent unauthorized changes once source data verification (SDV) is completed.
4. Validated Software (CSV) & Data Protection
- System Validation: Developed according to GAMP 5 guidelines within an ISO 9001 and ISO 27001 certified Quality Management System.
- Automated Backups: Daily geo-redundant backups ensure data durability and business continuity.
- Investigator Data Ownership: Complete data portability allows investigators to generate and retain certified, human-readable copies (PDF/CSV) of their site's data at trial closeout.
TMF Documentation & Compliance Packages
- Review our 21 CFR Part 11 and GCP Statements of Compliance.
- Download our ISO Standards and Quality Certificates.