Audit Readiness in Clinical Trials

Description

Course Overview

The sponsor of a clinical trial is accountable for establishing quality systems, including crafting an audit plan, to evaluate and ensure the dependability and integrity of each clinical trial in accordance with applicable written standards. An audit is performed to evaluate the adherence of the investigators and all site personnel to regulatory requirements, relevant guidelines and the clinical trial protocol. 

In clinical trials, audit readiness involves ensuring that all aspects of the trial, including documentation, processes, and compliance with regulations and protocols, are in order and readily accessible for inspection by regulatory authorities or independent auditors.

Audit Readiness in Clinical Trials is a comprehensive course, designed to equip participants with the essential knowledge and skills required to ensure audit readiness throughout the course of a clinical trial, both at the sites and the sponsor. Through a blend of theoretical learning and practical applications, participants will gain a deep understanding of the regulatory requirements, industry standards, and best practices for conducting clinical trials in a manner that is compliant, transparent, and audit-ready.

Key Learning Objectives

• Learn strategies and best practices for preparing clinical trial sites, documents, and personnel for regulatory inspections and audits, ensuring readiness and compliance to regulations and GCP guidelines.
• Explore the importance of accurate and comprehensive documentation in clinical trials, including essential documents, data management, and record-keeping practices to support audit readiness.
• Understand the roles and responsibilities of investigators in ensuring compliance with regulatory requirements, protocol adherence, and maintaining audit readiness at clinical trial sites.
• Learn how to identify root causes, address, and implement corrective and preventive actions (CAPA) in response to audit findings, non-compliance issues, or quality deviations identified during clinical trials.
• Analyse case studies and real-life examples of audit findings and inspection observations to understand common challenges, lessons learned, and best practices for achieving audit readiness.

Course Structure

The course is delivered through a combination of online lectures, instructor-led case studies, live group discussions, and interactive activities, spanning approximately 40 hours.

The lectures, exams, and supplementary materials are structured to be finished at your own pace. The practical masterclasses are conducted in real-time and have set schedules. For the most up-to-date information regarding masterclass schedules for this course, please reach out to us directly at info@clueoclinical.com. You’ll have up to 6 months from the onboarding date to finish all aspects of the course.

Target Audience

This course caters to individuals aspiring to pursue careers as Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), or Clinical Trial Auditors, even without prior clinical research experience. It’s important to note that while this course focuses on the clinical trial auditing aspect of these roles, it does not encompass all the knowledge required to become a CRA, CRC, or Auditor. For a comprehensive program covering all aspects of these roles, please refer to our signature Industry-Bridging programs.

Prerequisite

Having prior knowledge of ICH-GCP guidelines and the regulatory framework governing clinical trials is beneficial as it enables you to apply this knowledge effectively for audit readiness.

Certification

• To receive the completion certificate for the course, you must achieve a minimum score of ≥ 80% on all assessments.
• You have the opportunity to attempt the final course exam twice. If you do not pass after both attempts, you will be required to retake the entire course from the beginning.

Upon meeting these criteria, your certificate of successful completion will be awarded within 48 hours of course completion.

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