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'.
* 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
* 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
Tutors will be comprised from the list below:
Quality and Governance Manager, London School of Hygiene and Tropical Medicine (Course Principal)
Daiichi Sankyo Development Ltd
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:
Please note timings may be subject to alteration
|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?
|11.00||Investigations, Routine vs Cause for Audits
Difference between routine and for-cause audits.
Detecting questionable data.
|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.
Procedures to help minimise risk of fraud.
|14.15||Reporting, Follow-up and Legal Consequences
Management of internal investigations.
|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.
|16.30||Close of day|