Good Clinical Practice Auditing - Principles and Practice

Course Information

Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines.

How is this course run?

Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys.

What will I learn?

• A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments

• Solid grounding in quality assurance activities aligned with regulatory standards

• Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues
• Clarity on the roles and responsibilities inherent to clinical trials auditing
• Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents
• A nuanced understanding of regulatory inspectors' activities
• Expanded professional networks to propel your auditing career forward.

Benefits include:

• A clear understanding of the role of the auditor under Good Clinical Practice improved audits

• Improved Good Clinical Practice compliance for your clinical trials.

This course is structured to encourage delegates to:

• Discuss and develop ideas

• Solve specific problems

• Examine particular aspects of Good Clinical Practice.

Tutors

Tutors will be comprised of (click the photos for biographies):

Rosemarie Corrigan

EVP Global Quality, Worldwide Clinical Trials

Cathy Dove

Director and Owner, Dove Quality Solutions

Julie Kelly

Associate Director, Clinical Quality Assurance, Corcept Therapeutics

Susana Tavares

Director of Research Quality Assurance, -

Programme

Please note timings may be subject to alteration.

Day 1

12:30

Registration

13:00

Welcome and Objectives for the first day of the course

13:30

Laying the Foundations

Introduction to the clinical development process, the concepts of quality assurance, quality control and audit.

14:30

Break

15:00

Patient Protection

Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise.

16:05

Workshop 1 - Case Study on Informed Consent

16:45

End of Day Questions and Answers

17:00

Close of Day

Day 2

08:50

Questions and Answers from Day 1

09:00

Effective Site Audits

The procedures involved in selecting and setting up audits at investigator sites.

09:40

Workshop 1 - Planning the Effective Audit

10:30

Break

10:45

Source Data Verification

The need for and purpose of verifying data.

11:25

Workshop 2 - Source Data Verification

12:30

Lunch

13:30

IMP Management

The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction.

14:15

Critical Document Audits

The conduct of other study specific audits including protocols, databases and reports.

15:00

Break

15:15

Non-compliance

Determining the acceptability of data.

16:00

Fraud - Fact or Fiction?

How to identify fraud and its consequences

16:45

End of Day Questions and Answers

17:00

Close of Day

Day 3

08:50

Questions and Answers from Days 1 and 2

09:00

Auditing Third Parties

A review of audits of contract research organisations.

10:00

System Audits

The concept of auditing processes across many clinical trials, including a practical exercise in process mapping.

10:45

Break

11:00

Workshop 3 - Process Mapping

11:45

Effective Audits

Where theory meets reality.

12:30

Lunch

13:20

Audit Reports - Closing the Loop

An examination of the processes which follow the evidence gathering phase of the audit.

14:20

Workshop 4 - Audit Reports

Audit reports, corrective and preventive action.

15:00

Break

15:10

Regulatory Inspection

Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection.

15:55

Final Questions and Answers

16:10

Close of Course