T-009-006 Clinical Trial Technical Readiness Checklist
Purpose
This checklist must be completed for every clinical trial project before go-live. It serves as:
- A project setup guide — ensuring all mandatory deliverables are produced
- An audit-ready documentation index — providing a single point of access to all project documentation
- A regulatory traceability map — linking each deliverable to the applicable regulatory requirement
Instructions
- Complete all fields for the specific project
- Each deliverable must be marked as ✅ Complete, 🔄 In Progress, or ❌ Not Started
- All items must be ✅ Complete before the Technical Readiness Review (Phase 5 of SP-009-011)
- Approval signatures are required from JD-004, JD-005, and JD-013
Project Information
| Field | Value |
|---|---|
| Project Name | [Enter project name] |
| Project Record | [R-009-001] |
| Sponsor / CRO | [Enter name] |
| Contract Date | [YYYY-MM-DD] |
| Target Go-Live Date | [YYYY-MM-DD] |
| Project Manager (JD-013) | [Enter name] |
| Technology Manager (JD-007) | [Enter name] |
Phase 1 — Project Scoping and Device Provisioning
| # | Deliverable | Regulatory Basis | Status | Location / Reference | Notes |
|---|---|---|---|---|---|
| 1.1 | Device Provisioning Model (BYOD / Vendor-provided) with justification | MDR 17.3, 17.4 | ☐ | [link] | |
| 1.2 | Minimum Handset Specifications documented | MDR 17.3 (screen size, contrast), 17.4 (hardware, IT security) | ☐ | [link] | |
| 1.3 | Handset specifications communicated to sponsor/CRO | MDR Art 10(11), Annex I §23 | ☐ | [link] | |
| 1.4 | Image Capture Environmental Guidance prepared | MDR 17.3 (external factors) | ☐ | [link] | |
| 1.5 | IT Security measures documented (HTTPS, auth, no local persistence) | MDR 17.4 (protection against unauthorised access) | ☐ | [link] | |
| 1.6 | WebApp Feature Scope Document (included/excluded features) | ISO 13485 §7.1 | ☐ | [link] |
Phase 2 — End-to-End Data Flow and Architecture
| # | Deliverable | Regulatory Basis | Status | Location / Reference | Notes |
|---|---|---|---|---|---|
| 2.1 | Project-specific End-to-End Data Flow Diagram | MDR Annex II §1.1(j), ICH GCP E6 R3 §4 | ☐ | [link] | |
| 2.2 | Project-specific System Architecture Diagram (WebApp, API, AI, storage, CDN, CRO integration) | MDR Annex II §1.1(j), MDR Art 10(4) | ☐ | [link] | |
| 2.3 | Data input/output interfaces identified | MDR Annex II §1.1(j) | ☐ | [link] | |
| 2.4 | Security boundaries and access controls documented | MDR 17.4, ICH GCP E6 R3 §3.16 | ☐ | [link] |
Phase 3 — WebApp SDLC and CSV Controls
| # | Deliverable | Regulatory Basis | Status | Location / Reference | Notes |
|---|---|---|---|---|---|
| 3.1 | Core WebApp Development Controls documented (version control, code review, CI/CD, deployment) | ISO 13485 §7.3 | ☐ | [link] | |
| 3.2 | Study-specific Configuration Document (URL, access control, feature toggles, scoring systems, anonymization, data transfer, image requirements) | ISO 13485 §7.3, ICH GCP E6 R3 §3.16 | ☐ | [link] | |
| 3.3 | Functional testing results | ICH GCP E6 R3 §3.16 | ☐ | [link] | |
| 3.4 | Image capture and upload testing (target devices/browsers) | MDR 17.3 | ☐ | [link] | |
| 3.5 | DIQA validation results | MDR 17.3 | ☐ | [link] | |
| 3.6 | Data transfer validation (end-to-end to sponsor/CRO) | ICH GCP E6 R3 §4 | ☐ | [link] | |
| 3.7 | Access control testing | ICH GCP E6 R3 §3.16 | ☐ | [link] | |
| 3.8 | Anonymization testing (if applicable) | Study protocol | ☐ | [link] |
Phase 4 — Study Documentation Package
| # | Deliverable | Regulatory Basis | Status | Location / Reference | Notes |
|---|---|---|---|---|---|
| 4.1 | User Instructions (image capture guidelines, device requirements) for site staff / trial subjects | MDR Art 10(11), Annex I §23 | ☐ | [link] | |
| 4.2 | Data Transfer Agreement (DTA) signed | ICH GCP E6 R3 §4 | ☐ | [link] | |
| 4.3 | Project-specific user instructions prepared and approved | MDR Art 10(11), Annex I §23 | ☐ | [link] | |
| 4.4 | PACS/DICOM clarification included in study instructions | ICON audit recommendation | ☐ | [link] | |
| 4.5 | Study-specific instructions reviewed and approved | ISO 13485 §4.2 | ☐ | [link] |
Phase 5 — Technical Readiness Review
| # | Verification | Status | Notes |
|---|---|---|---|
| 5.1 | All Phase 1-4 deliverables marked as ✅ Complete | ☐ | |
| 5.2 | All documents accessible in project record (R-009-001) | ☐ | |
| 5.3 | Documentation package reviewed for audit readiness | ☐ |
Approval
| Role | Name | Signature | Date |
|---|---|---|---|
| JD-004 Quality Manager & PRRC | [Enter name] | [YYYY-MM-DD] | |
| JD-005 Technical Manager & PRRC | [Enter name] | [YYYY-MM-DD] | |
| JD-013 Project Manager | [Enter name] | [YYYY-MM-DD] |
Decision: ☐ GO — All deliverables complete, project approved for go-live | ☐ NO-GO — Outstanding items identified, go-live deferred
Associated Documents
| Reference | Title |
|---|---|
| SP-009-011 | Clinical Trial Project Setup and Technical Deliverables for CRO Engagements |
| SP-009-005 | Implementation Plan Helpers for Clinical Trials |
| SP-009-006 | Integration Workflow Helpers |
| GP-023 | Change control management |