Open deviations
7
3 overdueChecklist completion
84%
On trackISO 14155 gaps
5
Action neededTraining compliance
91%
CompliantNorm coverage
Recent deviations7 open
| ID | Description | Norm | Severity |
|---|---|---|---|
| DEV-041 | ICF signed post-procedure | ICH E6 | Critical |
| DEV-040 | PMCF plan not updated | ISO 14155 | Major |
| DEV-039 | Risk assessment gap | ISO 14155 | Major |
ISO 14155 key clause status
| Clause | Requirement | Applicability | Status |
|---|---|---|---|
| Cl. 6 – Ethics | IEC/IRB approval and ongoing review | ISO 14155 | Complete |
| Cl. 7 – CIP | Clinical Investigation Plan documented | ISO 14155ICH E6 | Complete |
| Cl. 8 – ICF | Informed consent per ISO 14155 §8 | ISO 14155ICH E6 | Gap found |
| Cl. 9 – Risk Mgmt | ISO 14971 risk management integration | ISO 14155 | In progress |
| Cl. 12 – PMCF | Post-market clinical follow-up plan | ISO 14155 | Gap found |
Monitoring visit
Site start-up
Close-out
| # | GCP requirement | Norm ref | Resp. | Status | Progress |
|---|---|---|---|---|---|
| 1 | Informed consent procedures verified | ICH E6 4.8ISO §8 | CRA | Complete | |
| 2 | Source data verification | ICH E6 5.18 | CRA | In progress | |
| 3 | Device accountability log verified | ISO §10.4 | Site | Pending | |
| 4 | Risk management file reviewed (ISO 14971) | ISO Cl.9 | Sponsor | Pending | |
| 5 | Adverse event / SAE reporting chain | ICH E6 4.11ISO §10.6 | PI | Overdue | |
| 6 | PMCF plan reviewed and current | ISO Cl.12 | Sponsor | Gap found | |
| 7 | Protocol deviations documented | ICH E6 4.5ISO §10.5 | Site | Complete | |
| 8 | Usability / performance data collected | ISO §10.7 | Site | In progress |
Site start-up checklist — coming soon
Close-out checklist — coming soon
Open
7
ISO 14155 specific
4
Overdue CAPA
3
Deviation log
| ID | Description | Norm ref | Severity | CAPA due | Status |
|---|---|---|---|---|---|
| DEV-041 | ICF signed post-procedure | ICH E6ISO §8 | Critical | 2025-03-24 | Open |
| DEV-040 | PMCF plan not updated | ISO Cl.12 | Major | 2025-04-01 | Open |
| DEV-039 | Risk mgmt file outdated | ISO Cl.9 | Major | 2025-04-05 | Open |
| DEV-038 | AE not reported within 24h | ICH E6ISO §10.6 | Critical | 2025-03-01 | Closed |
| DEV-037 | Device accountability gap | ISO §10.4 | Minor | 2025-03-10 | Closed |
Trial master file
ISO 14155 docs
Regulatory
| Document | Version | Norm ref | Uploaded | Status | Action |
|---|---|---|---|---|---|
| Clinical Investigation Plan (CIP) | 2.0 | ISO Cl.7 | 2025-01-15 | Approved | |
| Protocol v3.1 | 3.1 | ICH E6 | 2025-01-15 | Approved | |
| Risk Management File (ISO 14971) | 1.3 | ISO Cl.9 | 2025-02-10 | Review needed | |
| Informed Consent Form v2 | 2.0 | ICH E6ISO §8 | 2025-03-05 | Pending review | |
| PMCF Plan | 1.0 | ISO Cl.12 | 2024-11-01 | Outdated |
| ISO 14155 document | Clause | Uploaded | Status | Action |
|---|---|---|---|---|
| Clinical Investigation Plan (CIP) | Cl. 7 | 2025-01-15 | Approved | |
| Investigator's Brochure / Device Dossier | Cl. 7.4 | 2025-01-20 | Approved | |
| Risk Management File | Cl. 9 | 2025-02-10 | Review needed | |
| PMCF Plan | Cl. 12 | 2024-11-01 | Outdated | |
| IEC/IRB approval letter | Cl. 6 | 2024-10-05 | Approved | |
| SAE report template | Cl. 10.6 | 2025-01-08 | Approved |
Regulatory submissions — coming soon
Staff trained
18/20
2 overdueExpiring in 30 days
4
Action neededCompliance rate
91%
Target: 90%Training records
| Staff member | Role | Course | Norm | Expiry | Status |
|---|---|---|---|---|---|
| Dr. Chen, Wei | PI | GCP Fundamentals (ICH E6) | ICH E6 | 2025-04-15 | Expiring |
| Dr. Chen, Wei | PI | ISO 14155 Device GCP | ISO 14155 | 2026-01-10 | Current |
| Müller, Sabine | CRC | ISO 14155 Device GCP | ISO 14155 | 2026-03-20 | Current |
| Park, Ji-ho | CRA | Safety Reporting / SAE | ICH E6ISO §10.6 | 2025-05-03 | Expiring |
| Torres, Miguel | Site | ISO 14155 Device GCP | ISO 14155 | — | Not done |
Clauses covered
9/14
5 gapsCIP status
Current
Cl. 7PMCF plan
Outdated
Cl. 12Risk management
In review
Cl. 9ISO 14155:2020 clause trackerMedical devices — GCP for clinical investigations
| Clause | Requirement | ICH E6 overlap | Responsible | Status |
|---|---|---|---|---|
| Cl. 4 – Principles | Ethical, scientific, regulatory principles | ICH E6 2 | Sponsor | Complete |
| Cl. 5 – Sponsor | Sponsor responsibilities and oversight | ICH E6 5 | Sponsor | Complete |
| Cl. 6 – Ethics | IEC/IRB constitution and approval | — | Sponsor / Site | Complete |
| Cl. 7 – CIP | Clinical Investigation Plan content | ICH E6 6 | Sponsor | Complete |
| Cl. 8 – ICF | Informed consent elements for devices | ICH E6 4.8 | Investigator | Gap – ICF v2 pending |
| Cl. 9 – Risk Mgmt | ISO 14971 integration throughout CI | — | Sponsor | In progress |
| Cl. 10 – Conduct | Site conduct, monitoring, data integrity | ICH E6 4–5 | CRA / Site | Complete |
| Cl. 10.4 – Devices | Device accountability and traceability | — | Site | Pending |
| Cl. 10.6 – SAE | Serious adverse event reporting | ICH E6 4.11 | Investigator | Overdue |
| Cl. 11 – Monitor | Monitoring plan and visit requirements | ICH E6 5.18 | CRA | Complete |
| Cl. 12 – PMCF | Post-market clinical follow-up planning | — | Sponsor | Gap – plan outdated |
| Cl. 13 – Records | Essential documents and archiving | ICH E6 8 | Sponsor / Site | Complete |
| Cl. 14 – Audit | Audit trail and inspection readiness | ICH E6 5.19 | QA | In review |