Jump to content

Good Clinical Practice Auditing - Principles and Practice

RQA CPD Stamp

 

 

If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

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 but are new to GCP. Having knowledge of Good Clinical Practice prior to attending will maximise their learning in how to audit against the guidelines.  The 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:

Rosemarie Corrigan (Course Principal)
EVP Global Quality, Worldwide Clinical Trials

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

Cathy Dove
Director and Owner, Dove Quality Solutions

Julie Kelly
Associate Director, Clinical QA, Corcept Therapeutics Inc

MHRA

Recent Feedback

"Very good presentation style, explained easily but with great detail, planned exercises well. Knew the area in the course was for and could therefore share an insight into all questions."
"Had a good knowledge of the area, excellent exercise facilitation. Easily understandable but gave great detail in her presentations."
"There was a great group of delegates and I think of all the training I have attended these are the guys I interacted with the most, everyone had a different story to tell, different experience and backgrounds, lots of new contacts added on LinkedIn and lots of people I hope to meet again."

 

CPD Points

17 Points

Course Programme

Please note timings may be subject to alteration (last updated Sept 23)

 

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 Q&A
 17.00 Close of day 
 

Day 2 
 8.50 Q&A from Day 1
 9.00 Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
 9.40 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 Q&A
 17.00 Close of day 
 

 Day 3
 8.50 Q&A from Days 1&2
 9.00 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 Q&A
 16.10 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 additional 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 (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

Back to list

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

P08 The Auditing Course
P10 Implementing Good Clinical Laboratory Practice
P21 Audit Programmes and Risk Assessment
P32 Process Mapping and SOP Writing
P34 Practical Approach to Auditing Systems and Processes
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP21 Audit Programmes and Risk Assessment REMOTE LEARNING
RP22 Risk Management in Clinical Trials REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING

Webcasts

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

eLearning Products

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

Share

Share your experience on trustpilot.com

Trustpilot logo
Virtual Event Platform