Clinical Trial System Assessment Checklist

1) Regulatory alignment and quality foundations

• Clear intended use: which trial processes are covered (eConsent, ePRO/eCOA, EDC, eTMF, CTMS, safety, device data, etc.).
• GCP-aligned operational model: roles, responsibilities, training approach, and oversight responsibilities (sponsor, CRO, sites, vendors).
• Computerized system validation approach: documented validation strategy, traceable requirements, test evidence, and release controls.
• Electronic records and signatures: eSignature controls, signer identity, signature meaning, and linkage to records; time-stamps and non-repudiation.
• Data integrity principles: attributable, legible, contemporaneous, original, accurate (plus complete, consistent, enduring, available).
• Change control: controlled updates, impact assessments, release notes, and customer communication.
• Vendor qualification pack available: quality manual, SOP index, training, incident handling, business continuity, and audit support.

2) GDPR and EU/EEA privacy readiness

• Role clarity: supports controller/processor responsibilities and provides a Data Processing Agreement (DPA) and subprocessor list.
• Data minimization: captures only required data elements; configurable fields and retention limits.
• Purpose limitation: clear separation between trial operations, support, analytics, and product improvement activities.
• Privacy by design/default: least-privilege access, secure defaults, and configuration controls that reduce accidental exposure.
• Pseudonymization support: participant identifiers separated from study data; mapping stored securely with strict access.
• Rights handling: documented approach to data subject requests (where applicable) without compromising trial integrity and legal obligations.
• Data retention and deletion: configurable retention periods; defensible deletion/anonymization workflows; legal hold support.
• DPIA support materials: templates or inputs for risk assessment (data flows, security measures, subprocessors, hosting regions).

3) EHDS readiness (governance and future-proofing)

EHDS readiness is best assessed as practical governance maturity, not a label.

• Documented policies and procedures for health data handling, access, sharing, and oversight.
• Defined accountable roles (e.g., data governance, security, privacy, clinical operations) and documented responsibilities.
• Evidence management: ability to store, version, and audit governance artifacts (policies, SOPs, decisions, risk assessments).
• Interoperability mindset: structured exports, consistent metadata, and support for standard data models where relevant.
• Access and sharing controls: auditable authorization mechanisms and logs for internal and external data access.

4) Security controls (technical and organizational)

• Identity and access management: SSO options, MFA support, role-based access control, and segregation of duties.
• Encryption: in transit and at rest; key management approach and access limitations to keys.
• Audit logging: user actions, data changes, access events, exports, and configuration changes with tamper-evident retention.
• Vulnerability management: scanning cadence, patching SLAs, penetration testing cadence, and disclosure process.
• Incident response: documented IR plan, notification timelines, and customer communications process.
• Business continuity: backups, restore testing, RTO/RPO targets, disaster recovery, and failover strategy.
• Multi-tenant isolation: tenant separation model, safeguards against cross-tenant access, and testing evidence.
• Secure development lifecycle: code review, testing, dependency management, and release controls.
• Certifications and assurance: ISO 27001 / SOC 2 (if available), plus independent audit reports or customer audit support.

5) Hosting location, cross-border transfers, and “US hosting” risk review

“Secure” is not only technical. If data is hosted in the US (or administered by a US entity), evaluate both security and legal transfer requirements.

• Hosting regions: EU/EEA region availability; where primary data, backups, logs, and support data reside.
• Administrative access: where support staff are located; how privileged access is granted, approved, logged, and time-bounded.
• Transfer mechanism: availability of SCCs and supporting documentation for third-country transfers.
• Transfer impact assessment: documentation of risk assessment and supplementary measures (encryption, key control, access limits).
• Subprocessors: full list with locations and data categories; notification and objection process.
• Data residency commitments: contractual commitments and technical controls enforcing region selection.
• Customer controls: ability to restrict support access, manage export permissions, and approve privileged sessions.

6) Functional features (what the system should do)

7) Ease of use, setup, and adoption

• Time-to-first-study: clear onboarding steps, templates, and configuration guidance.
• Admin usability: intuitive configuration, guardrails, and permission-safe defaults.
• Training burden: available training materials, admin certification (optional), and change training on releases.
• Participant usability: mobile-friendly, accessible design, minimal friction, and multilingual UX.
• Operational support: ticketing SLAs, escalation paths, and study-critical support options.
• Configurability vs complexity: enough flexibility without creating fragile, hard-to-validate setups.

8) Reporting, analytics, and exports

• Standard reports: enrollment, compliance/adherence, query status, site performance, and participant engagement.
• Audit exports: audit logs exportable with filters, time ranges, and immutable evidence format.
• Data exports: scheduled exports, secure delivery, export approvals, and format support (CSV, JSON, standardized packages).
• Reproducibility: versioned exports, documented data transformations, and dataset lineage.

9) Pricing, cost drivers, and commercial terms

The goal is predictable total cost of ownership (TCO), not just license price.

• Pricing model clarity: per study / per participant / per site / per module / per environment.
• Setup fees: study build, validation package, training, integrations, and migration costs.
• Support tiers: included support vs premium support; after-hours availability; critical incident SLAs.
• Environment costs: sandbox/UAT/production separation and associated fees.
• Change costs: cost of amendments, new languages, added modules, and additional sites.
• Exit terms: data export formats, timelines, deletion certificates, and migration assistance.