Procedure for Handling Cases of Suspected Serious Breach, Misconduct & Fraud

Procedure for Handling Cases of Suspected Serious Breach, Misconduct & Fraud

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through ourย certificate online checker. They can also be shared on Linkedin.


Fraud and misconduct in research are on the rise globally with more of these being discovered at all stages of research. The consequence of fraud in research is that it defeats the purpose of evidence-based practice which should be based on facts established through research.

This is a course that exposes techniques used in detecting fraud in research. Included in the course are the different kinds of research frauds and the methods of identifying them. Participants also learn about the responsibility of sponsors, investigators, and regulatory agencies in curbing research fraud.



In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.







Lesson 1: Suspected Serious Breach, Misconduct & Fraud


  • Types of Fraud and Misconduct in Clinical Research
  • False Data Collection
  • Data Fabrication
  • Plagiarism
  • Fraud/Misconducted Cases


Lesson 2: Mechanisms to Identify Fraud and Misconduct


Lesson 3: Who is Responsible to Identify Fraud & Misconduct?


  • Responsibility of Authors and Colleagues
  • Responsibility of Journals
  • Responsibility of Institute or University


Lesson 4: Reporting Misconduct and Fraud


  • Policies Regarding Conduct, behavior, and Reporting
  • Responsibility of Employees and Management Team
  • Protection For Those Reporting Misconduct and Fraud
  • Cooperation with a Reporter During the Investigation


Lesson 5: Mechanisms to Prevent Misconduct


  • Primary and Secondary Preventions
  • Problems in the Prevention of Fraud and Misconduct


Lesson 6: Management of Misconduct and Fraud by Various Countries








Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects


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