Professional Audit Resource

Good Clinical Practices | ISO 14155
Clinical Investigation Full QMS Audit Package

A comprehensive, audit-ready checklist covering the complete lifecycle of medical device clinical investigations — from ethical review through post-market clinical follow-up.

ISO 14155:2020 ISO 13485:2016 ISO 14971:2019 ICH E6(R2) 21 CFR 812 21 CFR 50 & 56 EU MDR 2017/745 Annex XV Ch. II
100+
Audit Criteria
7
Major Audit Sections
8
Regulatory Frameworks
Rev 2.0
Technically Reviewed
Complete Coverage

What the Checklist Covers

Seven audit sections map directly to the ISO 14155:2020 clause structure, with integrated cross-references to FDA IDE requirements and EU MDR obligations.

01
Good Clinical Practices & Ethical Principles
Declaration of Helsinki compliance, informed consent (including 21 CFR 50), data privacy, EC/IRB oversight, and 21 CFR 56 IRB requirements.
Cl. 4–521 CFR 5021 CFR 56
02
Clinical Investigation Planning
CIP development, dedicated SAP section (analysis populations, interim analyses, multiplicity), amendment controls, EU MDR Art. 70 substantial modifications, and Investigator’s Brochure.
Cl. 6–7Cl. 12Art. 70
03
Sponsor & Investigator Responsibilities
Device accountability (labeling, storage, expiry, destruction, recall), site qualification, contracts, investigator conduct, and FDA IDE obligations (21 CFR 812.40, 812.110).
Cl. 8–9Cl. 15812.40812.110
04
Regulatory Submissions
IDE application content (812.25), EU MDR Annex XV Ch. II documentation, ongoing compliance, premature termination, and clinical investigation reports.
Cl. 10–11812.25Annex XV
05
Monitoring & Data Integrity
Risk-based monitoring strategy with KRIs, centralized monitoring, SIV/routine/close-out visits, SDV, EDC validation, and data management per 21 CFR Part 11.
Cl. 8.5Cl. 14ICH E6(R2)812.46
06
Safety Reporting & Vigilance
Correctly mapped to Clause 19. Full AE/SAE/SADE/USADE/DD classification hierarchy, reporting timelines, periodic safety reports, EU vigilance, and FDA IDE reporting.
Cl. 19Art. 80812.150
07
QMS Integration
Clinical → CER → PMS feedback loop (Annex XIV, Art. 82–83), design validation linkage (ISO 13485 §7.3.6), TMF archiving (Clause 16), clinical QA auditing, and CRO management.
Cl. 16Art. 82Art. 83ISO 13485
Built for Real Audits

Key Features

Every element was designed by a practicing Lead Auditor with over 20 years of medical device audit experience across SGS, BSI, and global regulatory bodies.

⚠

Corrected Clause Mapping

Safety reporting properly mapped to ISO 14155 Clause 19 (not Clause 20). Clause 20/11 correctly addresses final reports and premature termination. PSUR terminology replaced with investigation-specific periodic safety reporting.

⚖

Safety Event Definitions Table

Pre-built reference table with ISO 14155:2020 definitions for AE, SAE, SADE, USADE, and Device Deficiency — ensuring consistent classification across auditors and auditees.

■

Critical Nonconformity Rating

Rating scale includes Critical NC category for findings with direct subject safety or data integrity impact, with a documented escalation logic table defining notification paths and response timelines.

⇄

Clinical → CER → PMS Loop

Dedicated subsection evaluating the feedback from clinical investigation outputs into Clinical Evaluation Reports, PMS plans, and PMCF study design — per EU MDR Annex XIV, Articles 82 and 83.

★

Dual-Jurisdiction Depth

Full FDA IDE mapping (21 CFR 50, 56, 812.25, 812.40, 812.46, 812.110, 812.150) alongside EU MDR coverage (Art. 62, 70, 77, 80, 82, 83, Annex XV Ch. II) in a single integrated tool.

⚙

Statistical Governance

Dedicated SAP section covering analysis populations (FAS, PP, Safety), interim analyses with stopping boundaries, multiplicity adjustments, and biostatistician approval controls.

Complete Package

What You Receive

Production-ready audit documentation that can be deployed immediately for sponsor system audits, internal audit preparation, or clinical QA assessments.

Full QMS Audit Checklist (.docx)

Cover page with audit metadata, scope definition, and applicable standards
Table of Contents with hyperlinked headings
Audit finding rating scale with Critical NC and escalation logic table
Safety event definitions reference table (AE / SAE / SADE / USADE / DD)
7 detailed audit sections with 100+ criteria, clause references, and evidence/finding columns
Findings summary table with category counts and section tracking
Nonconformity detail & CAPA requirements table (5 rows)
Audit conclusion and approval signature block
Full revision history documenting all technical corrections
Why This Tool

This Package vs. Generic Templates

This Audit Package

  • Safety reporting correctly mapped to Clause 19
  • Dedicated SAP, device accountability, and archiving sections
  • Full AE/SAE/SADE/USADE/DD hierarchy with definitions
  • Critical NC rating with escalation logic
  • Clinical → CER → PMS feedback loop
  • Dual FDA + EU MDR coverage in one tool
  • EU MDR Art. 70, 82, Annex XV Ch. II included
  • Risk-based monitoring with KRI requirements
  • Technically reviewed by independent regulatory expert

Typical Generic Templates

  • Safety clauses often misreferenced or incomplete
  • Statistical governance missing or buried in CIP
  • No distinction between SAE, SADE, and USADE
  • Binary pass/fail only — no Critical NC category
  • No link to CER, PMS, or PMCF requirements
  • Single-jurisdiction or surface-level regulatory mapping
  • Substantial modification process not addressed
  • Monitoring plan checked but not strategy-assessed
  • Template quality rarely verified against current standards
Applications

Who Should Use This

Designed for quality and regulatory professionals who need an audit tool that reflects current standards and real-world audit expectations.

S

Sponsors & Manufacturers

System-level self-assessment of clinical investigation programs before regulatory inspections or notified body audits. Gap analysis tool for new clinical programs.

Q

Clinical QA Teams

Independent quality audit of clinical operations, CROs, investigational sites, and data management centers. Structured basis for clinical QA audit programs per ISO 14155 §8.7.

R

Regulatory Affairs Professionals

Verification that regulatory submission documentation meets IDE and EU MDR clinical investigation application requirements before filing.

C

Consultants & Auditors

Ready-to-deploy audit tool for client engagements. Reduces preparation time while ensuring comprehensive, standards-aligned coverage.

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© 2026 SA Quality Solutions LLC — Medical Device Quality & Regulatory Consulting

This document is provided for professional reference. Content reflects ISO 14155:2020, EU MDR 2017/745, and 21 CFR 812 as current at the date of publication. Always verify against the latest editions of applicable standards and regulations.