Healthcare professional in blue scrubs using a tablet while completing clinical research documentation

Corrective and Preventive Actions (CAPAs) in Clinical Trials

$84.00

Clinical trials operate within a highly regulated framework designed to protect participant safety and ensure data reliability. When Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), or protocol requirements are not followed, deviations, non-compliance, or non-conformance occur and must be properly addressed. ICH GCP requires that significant issues are identified, documented, explained, and managed through Corrective and Preventive Actions (CAPAs).

A CLEAR UNDERSTANDING OF CAPA PRINCIPLES IS ESSENTIAL FOR EFFECTIVE QUALITY MANAGEMENT.

Applying Corrective and Preventive Actions (CAPAs) is not simply about understanding definitions — it requires sound quality decision-making in complex, real-world situations.

This course is designed to strengthen the decision-making capability required to deliver inspection-ready clinical trials. It enables learners to move beyond definitions and templates to critically evaluate issues and implement CAPAs that are Specific, Measurable, Achievable, Relevant, and Time-bound (SMART), with clearly defined roles, responsibilities, and accountability mechanisms that support effective implementation and help prevent recurrence of errors.

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Categories: Competency Training, Course

Description
During this course, you will learn about:

Description

What can you expect from this course?

Corrective and Preventive Actions (CAPAs) in Clinical Trials, is a TASK Research Academy competency short course that will guide you from critical trial issue evaluation to developing and implementing clear, effective and defensible CAPA measures to ensure inspection-ready actions that protect trial integrity.

Who must attend this course?

This course is designed for any member of a Sponsor, Contract Research Organisation (CRO), Service provider, or Clinical research site team who is responsible for documenting, reporting, investigating, reviewing, or responding to major deviations, non-compliances, or non-conformances, as well as those involved in reviewing or addressing major and/or critical audit and inspection findings.

It is particularly relevant for (but not limited to):

Research Nurses
Site Managers
Study Coordinators
Investigators (Principal and Sub-Investigators)
Research Pharmacists
Laboratory Personnel
Quality Assurance (QA) Professionals
Auditors
Clinical Research Associates (CRAs)

During this course, you will learn about:

What you’ll master in this course:

What CAPAs are, and when they are required
How to grade issues by impact on safety and data integrity
Why CAPAs matter
The Do’s and Don’ts when drafting CAPAs
How to draft a SMART CAPA
Why some CAPAs fail
CAPA effectiveness and sustainability
How to manage and report CAPAs
Applying knowledge in real-world situations through interactive decision-making

Learn Through Storytelling:

Follow the story of Epic Medicine, a sponsor based in New York, and their Phase III trial, TBCure. Study management is delegated to the CRO Trial Assist in the UK, whose CRAs oversee five research sites across Africa, South America, and India.

Master Decision-Making Through Interactive Simulation Scenarios:

Step into real-world clinical research challenges in a safe, guided learning environment.
We set the scene — a realistic case involving a deviation, non-compliance issue, or CAPA challenge — and you are placed at the centre of the decision-making process. Your task is to analyse the situation, choose your response, and see the downstream impact of your decisions unfold.

Each scenario is designed to mirror the complexity of real clinical trial environments, where decisions have operational, ethical, and compliance consequences.

This is not passive learning. It is active, scenario-based simulation that builds:

Critical thinking
Clinical trial decision-making confidence
Practical CAPA competency

By working through consequences in a controlled setting, you develop the skills needed to manage deviations and implement effective CAPAs in real-world clinical trials — with clarity, confidence, and regulatory awareness.

The course concludes with an Assessment on CAPAs to test your understanding of this essential component to trial conduct.