Clinical Data Protocols
Standardized frameworks governing data collection, management, quality control, and regulatory reporting across Aevum Zenth Health Sciences clinical operations.
Active Protocol Frameworks
Primary Outcome Data Collection
Defines endpoints, assessment timing, measurement tools, central adjudication, and handling of missing data for Phase II-IV trials.
EDC System Validation & Security
Computerized system validation, role-based access controls, electronic signatures, and immutable audit trail requirements.
Real-World Evidence (RWE) Integration
Standards for incorporating EHR, claims databases, and digital wearable data into interventional trial datasets.
Adverse Event & SAE Reporting
Classification, MedDRA coding, 24/24h escalation windows, causality assessment, and regulatory submission workflows.
Regulatory Alignment & Compliance Mapping
All data protocols are formally mapped to applicable regulatory frameworks. Cross-references ensure audit readiness, inspection preparedness, and global trial compliance.
| Framework / Standard | Scope & Applicability | Key Requirements | Protocol Mapping |
|---|---|---|---|
| ICH-GCP E6(R2) | Global Clinical Trials | Subject rights, protocol adherence, monitoring plans, quality management | All CDP Series |
| FDA 21 CFR Part 11 | Electronic Records & Signatures | Validation, audit trails, role-based access, secure storage | AZ-CDP-004 AZ-CDP-009 |
| GDPR / HIPAA | Patient Privacy & Data Rights | Data minimization, explicit consent, cross-border transfer restrictions | AZ-CDP-003 AZ-CDP-015 |
| CDISC Standards | Data Interchange & Submission | SDTM/ADaM formatting, controlled terminology, domain mapping | AZ-CDP-006 AZ-CDP-008 |
Protocol Implementation & Governance Support
Clinical data managers, biostatisticians, and site coordinators can request protocol amendments, validation documentation, or regulatory consultation through the centralized helpdesk.