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Good Clinical Practice Auditing - Principles and Practice

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Course Information

This two-and-a-half-day course offers the ideal training opportunity for moving into the field of auditing clinical studies.  The course will be of value to those familiar with Good Clinical Practice (GCP), but aiming to apply the principles to auditing; and for those who have audited in other disciplines but are new to GCP. The first afternoon of the course provides an introduction to Good Clinical Practice. The remaining two days concentrate on the practicalities of clinical trial auditing. Workshops give the delegates practical experience of using auditing techniques in a GCP context.  All of the tutors are seasoned auditors who relate theory to their own experiences.

By the end of the course delegates will have

  • a clear understanding of the history and aims of Good Clinical Practice and up-to-the-minute developments
  • a sound regulatory basis for quality assurance activities
  • an idea of what can go wrong with clinical trials and how the auditor can help
  • an understanding of the roles and responsibilities of the clinical trials auditor
  • explored a range of techniques for audit, with examples of helpful documents
  • gained an insight into the activities of the regulatory inspectors
  • developed networking contacts to further their auditing career

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

Course Tutors

Tutors will be comprised from the list below:

Paul Strickland
Managing Director, Strickland Quality Assurance Ltd (Course Principal)

Susana Tavares
Head of Research Quality Assurance, BIAL-Portela & Companhia SA

Cathy Dove
Director and Owner, Dove Quality Solutions

Rosemarie Corrigan
Chief Quality Officer, Nordic Nanovector

Glene Sandom
Executive Director, GxP Corporate Audit EMEA, Celgene Europe Limited

MHRA

Recent Feedback

"All speakers were very clear and concise with their presentations, easily understood and well prepared."
"All tutors very knowledgeable and could give plenty of real life examples which was great."
"Great mix of presenters with a wealth of experience. Loved hearing the examples and anecdotes as that is how I will recall particular points moving forwards."
"Overall I thought the presenters were fantastic and very engaging, and the workshops all very useful."
"Particularly liked the audit report section - great experience and examples to augment presentation."

CPD Points

17 Points

Course Programme

Please note timings may be subject to alteration

 

Day 1 - GCP Introduction 

11.45 Registration 
 12.00 Welcome and Objectives for the first day of the course 
 12.45 Lunch 
 13.30 Laying the Foundations
Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 
 14.30 Today's Regulatory Framework
A brief review of the regulations and guidelines that describe Good Clinical Practice.
 15.25 Break 
 15.45 Patient Protection
Requirements for informed consent and ethics committee .
Access to source documentation.
Including a patient protection exercise.
 17.45 Close of day 
 

Day 2 

 8.50 Welcome and Course Objectives
 9.00 Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
 9.35 Introduction to Workshops
 9.45 Workshop 1 - Planning the Effective Audit
 10.35 Break 
10.50 Source Data Verification
The need for and purpose of verifying data. 
11.20 Workshop 2 - Source Data Verification
12.30 Lunch
13.15 Workshop 2 - Feedback 
 13.45 IMP Management
The requirements surrounding the distribution of investigational medicinal products.
Accountability from release to destruction. 
 14.25 Workshop 3 - IMP Accountability
 15.10 Workshop 3 - Feedback 
 15.40 Break 
 16.00 Critical Document Audits
The conduct of other study specific audits including protocols, databases and reports. 
 16.45 Non-compliance
Determining the acceptability of Data 
 17.30 Close of day 
 

 Day 3

 8.50 Questions and Answers
 9.20 Auditing Third Parties
A review of audits of contract research organisations. 
 10.20 Break
 10.40 System Audits
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 
 11.15 Workshop 4 - Process Mapping 
 11.55 Effective Audits
Where theory meets reality. 
 12.25 Lunch 
 13.10 Audit Reports - Closing the Loop
An examination of the processes which follow the evidence gathering phase of the audit. 
 13.45 Workshop 5 - Audit Reports
Audit reports, corrective and preventive action. 
 14.40 Regulatory Inspection
Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 
 15.50 Break 
 16.05 Fraud - Fact or Fiction? 
 16.40 Close of course 
   
   
   
   

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

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.

Additional Requirements
(not included in course fees)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.
Bed and Breakfast is £77*, dinner is £35*  (* per night per person) - these can be selected during the booking process.

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Recommended Products

Booklets

A Monitor’s Guide to Investigator Site Audits
CAPA: Effective Approaches to Improvement*
Good Clinical Practice Regulatory Authority Inspections
Investigators' Guide to Investigator Site Audits
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
P08 The Auditing Course
P10 Implementing Good Clinical Laboratory Practice
P16 Good Laboratory Practice Refresher
P21 Audit Programmes and Risk Assessment
P32 Process Mapping and Using Maps in Standard Operating Procedures Writing
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting

Webcasts

Webcast - The Biggest Change to International GCP
Webcast - Where Does Audit End?

eLearning Products

Introduction to Good Clinical Practice (GCP) elearning
Introduction to UK Clinical Trial Regulations elearning
Introduction to the Audit Process elearning

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