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Fraud and Misconduct: Detection, Investigation and Management

Would you feel confident to deal with a highly charged investigation into potentially suspicious data? When data, reputations and relationships are at stake, it is essential to know how to assess concerns of misconduct in clinical trials - the last thing you can afford to do is to ignore them.

This course is designed for the QA professional who will hopefully never encounter clinical fraud, but who wishes to be prepared 'just in case'.

Benefits include
* Learning how to approach investigations into fraud and/or misconduct
* Practice reviewing data for 'red flags'
* Checking what goes into policies and procedures
* Sharing concerns in a friendly and confidential environment

Course Objectives
* Understand the definitions and differences between fraud, misconduct and non- compliance
* Learn how to conduct a for-cause audit into possible fraud
* Initiate the development of appropriate policies and procedures
* Gain an understanding of the management of investigations, including their follow-up


Course Tutors

Tutors will be comprised from the list below:

Patricia Henley
Quality and Governance Manager, London School of Hygiene and Tropical Medicine (Course Principal)

Barney Horne
Daiichi Sankyo Development Ltd

Paul Strickland
Managing Director, Strickland Quality Assurance

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.

Course Programme

Please note timings may be subject to alteration

 8.30 Registration 
 9.00 Welcome and Introductions 
 9.15 Fraud and Scientific Misconduct: Fact or Fiction?
Definitions and history. 
 10.00 Non-compliance vs Fraud
Protocol deviations and breaches.
When does non-compliance become misconduct? 
 10.45 Break 
 11.00 Investigations, Routine vs Cause for Audits
Conducting investigations.
Difference between routine and for-cause audits.
Interview techniques. 
 11.45 Red Flags
Detecting questionable data. 
 12.15 Lunch 
 13.15 Workshop 1 - Learning to Detect Fraud
Practical session on looking at red flags to help detect possible fraud. 
 13.45 Policy Development and Process Improvement
Implementation if the Research Integrity Concordat.
Organisational responsibilities.
Procedures to help minimise risk of fraud.
 14.15 Reporting, Follow-up and Legal Consequences
Management of internal investigations. 
 15.00 Break 
 15.15 Workshop 2 - When it Hits Close to Home - Case Studies
Discussion-led session where delegates are given case studies to discuss approaches and investigations. 
 16.15 Closing Remarks
Q&A.
Final Discussion. 
 16.30 Close of day 

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Recommended Products

Booklets

Auditing Computerised Systems Booklet
Computerised System Validation Booklet
Quality Risk Management Booklet

Courses

P01 Introduction to Computer Systems Validation

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