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QA/RA Consulting, Auditing & Training

Good Clinical Practice for Clinical Investigations of Medical Devices – ISO 14155:2020

This course explores the essentials of ISO 14155, the international standard for Good Clinical Practice (GCP) in medical device investigations. Participants will gain the knowledge needed to ensure clinical investigations uphold the highest standards of human subject protection. Through engaging examples and hands-on exercises, the course enables the effective application of ISO 14155 principles in real-world situations.

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Brief Overview of This ISO 14155 Good Clinical Practices Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

4 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

1.6

* SkillsLab classes delivered in person (private or public) are full-day sessions delivered over 2 consecutive days.

** Interested in private training for your team, virtually or in person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Training Classes on Good Clinical Practices

SkillsLab $3300

SkillsLab $3300

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

What We Cover in This Intensive Class on Good Clinical Practice

This course covers ISO 14155:2020 requirements, providing participants with the knowledge and skills to protect human subjects. Through real-world examples and exercises, participants will learn to apply ISO 14155 principles at all stages of a clinical investigation. The course also clarifies the roles of sponsors, investigators, ethics committees, and regulatory authorities, and includes best practices for GCP audits and inspections.

Course Overview

SkillsLab Class

Good Clinical Practices (GCP) Overview (Clause 4)

Basics of GCP requirements
Global landscape of GCP requirements
ISO 14155:2020 (clauses 0-4)

Ethical Considerations (Clause 5)

Requirements from ISO 14155:2020 for:
- Respect for human subjects
- Informed consent
- Investigator considerations

Workshop! Listing the Elements of a Consent Form

Clinical Investigation Planning (Clause 6)

Planning requirements from ISO 14155:
- Design of clinical investigations
- Site selection
- External data monitoring, core labs
- Risk considerations
- Clinical investigation plan documents
- Monitoring
- Agreements
- Labeling

Workshop! Develop Clinical Investigation Planning Documentation, Part 1

Workshop! Develop Clinical Investigation Planning Documentation, Part 2

Clinical Investigation Conduct (Clause 7)

Site initiation and monitoring
Handling adverse events and deficiencies
Privacy and confidentiality of subject data accountability
Document and data control

Suspension, Termination, and Close-Out (Clause 8)

ISO 14155:2020 requirements for:
- Completion of clinical investigation
- Suspension or premature termination
- Reporting
- Conclusions

Workshop! Framework of a Clinical Report

Sponsor Responsibilities (Clause 9)

Sponsor responsibilities
- Quality management
- Monitoring
- Safety evaluation / reporting (role of data monitoring)
- Outsourcing
Communication

Investigator Responsibilities (Clause 10)

Principal investigator responsibilities
- Qualifications
- Communication
- Informed consent
- Medical care
- Reporting

Workshop! Comparison or Review of Sponsor vs. Investigator Roles

Clinical Investigation Audits

Clinical investigation audit basics
Sponsor vs. site audits
Common findings
Responsibilities
FDA and EU requirements

What You Will Learn

At the conclusion of this training class, you will be able to

SkillsLab

Describe the purpose, scope, and key requirements of ISO 14155

Explain the responsibilities of sponsors, investigators, ethics committees, and regulatory authorities under ISO 14155

Describe the basics of good clinical practice (GCP) audits and inspections

Apply ISO 14155 to the planning, conduct, and closing of clinical investigations

Who Should Attend

This course is essential for anyone involved in the planning, conduct, or oversight of clinical investigations of medical devices. This includes regulatory affairs professionals, ethics committee members, and other stakeholders in the medical device industry.

Clinical Project Managers
Clinical Investigators
Regulatory Affairs Specialists
Regulatory Managers
Quality Assurance Managers
Product Managers
Quality Compliance Personnel

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