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Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING


REMOTE LEARNING - this course will be delivered to you live online from the UK. 

Course Information

This 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. Delegates are expected to have some knowledge of Good Clinical Practice prior to attending to maximise their learning in learning how to audit against the guidelines.  The course 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 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:

Patricia Henley
Head of Research Governance and Integrity, London School of Hygiene and Tropical Medicine (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


Recent Feedback

"RQA online courses are a brilliant resource. Remotely located RQA members now have a much greater opportunity to learn and participate."
"Made serious subjects fun and interesting at time, very nice presentation style. Very knowledgeable. All presenters very good at facilitating the exercises and providing good feedback."
"Presenters had a good level of knowledge and expertise and this meant sharing lots of valuable experiences in all areas of auditing."

CPD Points

17 Points

Course Programme 

Please note this course will run in UK timezone.


Day 1

9.30 Welcome and Objectives for the first day of the course
 9.50 Laying the Foundations
Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 
 11.00 Break
 11.20 Today's Regulatory Framework
A brief review of the regulations and guidelines that describe Good Clinical Practice.
 12.30 Lunch 
 13.30 Patient Protection
Requirements for informed consent and ethics committee .
Access to source documentation.
Including a patient protection exercise.
15.40 Break
16.00 Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
16.45 Introduction to Workshops/end of day Q&A
17.15 Close of day

Day 2 

 9.00 Workshop 1 - Planning the Effective Audit
 10.00 Source Data Verification
The need for and purpose of verifying data. 
 10.40 Break 
11.00 Workshop 2 - Source Data Verification
12.10 Workshop 2 - Feedback
12.40 Lunch
 13.40 IMP Management
The requirements surrounding the distribution of investigational medicinal products.
Accountability from release to destruction. 
 14.40 Critical Document Audits
The conduct of other study specific audits including protocols, databases and reports.
 15.35 Break 
 15.55 Non-compliance 
Determining the acceptability of Data 
17.05 End of day Q&A
 17.20 Close of day 

 Day 3

 9.00 Auditing Third Parties
A review of audits of contract research organisations. 
 10.10 System Audits
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 
10.55 Break
 11.10 Workshop 3 - Process Mapping 
 11.50 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. 
 14.05 Workshop 4 - Audit Reports
Audit reports, corrective and preventive action. 
14.55 Break
 15.10 Regulatory Inspection
Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 
 16.20 Fraud - Fact or Fiction? 
 17.20 Final Q&A
17.30 Close of course

Course Material

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.

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
  • Access to an online course group to enhance networking

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





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Investigators' Guide to Investigator Site Audits
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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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