Good Clinical Practice Auditing - Principles and Practice

Description

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.

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.

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

EVP Global Quality, Worldwide Clinical Trials

Director and Owner, Dove Quality Solutions

Associate Director, Clinical Quality Assurance, Corcept Therapeutics

Director of Research Quality Assurance, -

Please note timings may be subject to alteration.

Registration

Welcome and Objectives for the first day of the course

Laying the Foundations

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

Break

Patient Protection

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

Workshop 1 - Case Study on Informed Consent

End of Day Questions and Answers

Close of Day

Questions and Answers from Day 1

Effective Site Audits

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

Workshop 1 - Planning the Effective Audit

Break

Source Data Verification

The need for and purpose of verifying data.

Workshop 2 - Source Data Verification

Lunch

IMP Management

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

Critical Document Audits

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

Break

Non-compliance

Determining the acceptability of data.

Fraud - Fact or Fiction?

How to identify fraud and its consequences

End of Day Questions and Answers

Close of Day

Questions and Answers from Days 1 and 2

Auditing Third Parties

A review of audits of contract research organisations.

System Audits

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

Break

Workshop 3 - Process Mapping

Effective Audits

Where theory meets reality.

Lunch

Audit Reports - Closing the Loop

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

Workshop 4 - Audit Reports

Audit reports, corrective and preventive action.

Break

Regulatory Inspection

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

Final Questions and Answers

Close of Course

Face-to-face course

Course material will be available in PDF format for delegates attending this course. The advantages of this include:

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Remote course

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.

Please note this course will run in UK timezone.

You will need a stable internet connection, a microphone and a webcam.

17 Points

Develop