Industries: Pharma / BiotechMedical Device

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

Course Director: Glenda Guest

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course***

Certification Tracks

This Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Course Description -

This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites.

Additionally, attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies.

Additionally, the course will cover methods to detect misconduct and deal with fraud in clinical trials by:

  • Defining the basic requirements of Good Clinical Practices
  • Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial
  • Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials
  • Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection
  • Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials
  • Building trial guidelines/structure which will easily identify any misconduct and which is capable of quickly addressing any issues that arise in order to avoid regulatory consequences

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Who Should Attend

A GCP audit can lead to the detection of problems with the conduct of the clinical trial. It is important to understand the differences between lack of knowledge and poor execution versus actual misconduct and fraud. This two-day course will discuss some of the common issues seen in clinical trials, how to handle problem findings, and how to distinguish between poor performance and misconduct.

This GCP training course will benefit those involved in the monitoring and/or QA of clinical trials. Attendees who work for Pharmaceutical or Biotech firms, Medical Device companies, Contract Research Organizations (CRO), Institutional Review Boards (IRBs), and academic institutions involved with the supervision or oversight of clinical trial practices and quality will find this course to be highly beneficial.

First Day

Session 1-Defining the Basic Requirements of GCP

  • Terminology
  • Overview of clinical compliance laws
    • FDA, ICH, ISO and global requirements
  • Understanding the role of the FDA, OHRP and IRBs
  • How the GCP guidelines help in good studies
  • Understanding the roles and responsibilities of the clinical research team
  • Group discussion of interpreting regulatory requirements for GCP

Session 2-Industry Overview – FDA Regulatory Requirements – Are You Ready for an FDA Inspection?

  • Understanding regulatory obligations
  • Identifying key documents
  • Differences and similarities for drugs and device audits
  • Compliance issues

Session 3-The Different Types of Audits

  • When and why to audit
  • Who and what is inspected
  • Audit problems and issues
  • What to avoid
  • Data quality and integrity issues & solutions

Session 4-Role of Monitoring in Detecting Misconduct

  • Defining the difference between auditing and monitoring
  • What are the big items that must be in place
  • Common problems
  • Knowing what questions to ask in monitoring a site
  • Pointing out site performance deficiencies
  • Identifying solutions to deficiencies
  • What to do if misconduct is suspected

Second Day

Session 5-Conducting GCP Audits

  • Different types of audits
  • Key activities during an audit
  • What to expect and common findings
  • Audit reports and follow-up

Session 6-FDA BIMO Inspections

  • Preparing for the visit
  • Source documentation: How much is enough?
  • Common GCP deficiencies
  • Recent BIMO results
  • Review potential roadblocks of non-compliance
  • Identifying potential problems early

Session 7-Preventing Fraud and Scientific Misconduct

  • Maintaining accurate records
  • How to detect fraud in case report forms and clinical trial materials
  • Misleading data and results
  • Examples of fraud

Session 8-Non-FDA audits

  • Identifying other groups
  • Role in the detection of fraud and misconduct
  • Interactions with FDA and consequences

Session 8-Case examples of misconduct and fraud

  • Key findings from recent cases
  • Types of problems and possible preventive actions

Learning Objectives

Upon completion, attendees will be able to:

  • Identify and define the principles and requirements for GCPs
  • Define the basic roles and responsibilities of the sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
  • Understand the GCP audit process for sponsors
  • Know when to conduct audits of vendors, sites, IRBs and laboratories
  • Ensure that your data and supporting documentation are accurate and presentable for inspection
  • Gain knowledge concerning common outcomes and findings in clinical trials
  • Understand how to respond to an audit to avoid further regulatory consequences
  • Learn how to detect and prevent fraud and misconduct in clinical trials
  • Fully understand the consequences which result when proper procedures are not followed, through the use of examples

Case study analysis, exercises and videos will be used throughout the course to provide insight and promote discussion.


"Instructor was extremely knowledgeable and presented in a way that kept my attention despite work distractions. I appreciated the industry examples provided." Danielle P., Manager, Quality Systems, NAMSA
"The course was very well presented, and it was not rushed. The information was detailed and flowed well. The course content was supported by real examples." Sanjay M., Global Director of Quality Systems, NAMSA
"The Program content was informative and useful for GCP concepts and the Course Director was very knowledgeable and interactive." Archana P., QA Manager, SK Lifescience
"This was my first training course and I loved it! I enjoyed the examples of misconduct to show how the systems in place operate when bad research is conducted." Andrew, Compliance Officer, UCLA
"A great instructor!! I truly learned a lot, and he kept us all very engaged." Andrea D., CRA, Medtronic
"The small class allowed for great class discussion. Course Director was VERY KNOWLEDGEABLE on the topic. He was able to address all questions." Karen W., Senior Scientific Compliance Scientist, AbbVie
"This is one of the best courses I have ever taken. The Course Director was very clear and straight to the point. The content was up to date and full of real-life examples!" Marilia B., Compliance & Training Manager, Roche Brazil
"Although some of the material was a review for me, I felt it was presented very well. The instructor kept the course interesting through discussions and interactions with attendees." John V., Clinical Program Manager, Sorin Group
"The Course Director gave many practical, real life examples on dealing with and detecting fraud and misconduct. He was very knowledgeable and engaging." John D., Quality Assurance Auditor, Johnson & Johnson

Frequently Asked Questions

How is fraud or misconduct defined by FDA?

Fraud or misconduct is defined as the collection, submission or use of data or information that falsely represents what happened during a study. Misconduct can include errors of omission (leaving out data) or errors of commission (intentionally using false data).

After I take this course will I be ready to perform an audit?

The purpose of this course is to learn some of the best practices for ensuring compliance and conducting an audit. There is much more to conducting an audit than taking a course. The goal of this course is to provide the fundamentals background one needs to become an auditor.

What are the top issues currently seen by FDA during inspection of clinical sites?

Over the years, the most common inspection findings from FDA still relate to not following the protocol, protocol deviations, and subject protection issues for sites and inadequate oversight (monitoring) and follow-up on issues identified for sponsors/CROs.

How is auditing different from monitoring a study?

Monitoring is the ongoing process of overseeing a study to ensure patient safety, data quality, protocol compliance, and regulatory compliance. Auditing on the other hand are the processes we use to assure that study procedures and processes have been followed, and to verify that all aspects of the study were conducted according to the protocol. Monitoring can be thought of as quality control, while auditing is quality assurance.

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