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43 - MDC - Medical Sciences and Clinical Research

MDC 115 - Auditing Clinical Trials for GCP Best Practices

Code Start Date Duration Venue
MDC 115 10 April 2023 5 Days Istanbul Registration Form Link
MDC 115 05 June 2023 5 Days Istanbul Registration Form Link
MDC 115 31 July 2023 5 Days Istanbul Registration Form Link
MDC 115 25 September 2023 5 Days Istanbul Registration Form Link
MDC 115 20 November 2023 5 Days Istanbul Registration Form Link
Please contact us for fees


Course Description

This course provides a solid understanding of Good Clinical Practice (GCP) requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will learn methods and techniques for detecting, correcting and preventing clinical study misconduct and fraud at domestic and international clinical sites.

The course will also address how to uncover misconduct, as well as methods for dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the coursework are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation.

Course Objectives

  • Identifying and defining the principles and requirements for GCPs
  • Defining the basic roles and responsibilities of the sponsor, monitor, investigators 
  • Understanding the GCP audit process for sponsors
  • Knowing when to conduct audits of vendors, sites, IRBs and laboratories
  • Ensuring data and supporting documentation are accurate and presentable for inspection
  • Gaining knowledge concerning common outcomes and findings in clinical trials

Who Should Attend?

  • Those involved in the monitoring and/or QA of clinical trials.
  • Professionals involved in the pharmaceutical or biotechnology sectors
  • Professionals who work in Contract Research Organizations (CRO),
  • Those involved with the supervision and oversight of clinical trial practices will find this course to be highly beneficial.

Course Details/Schedule

Day 1

Introduction and Overview

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

Industry Overview –Regulatory Requirements

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

Day 2

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

Day 3

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 and ways to dissolve them
  • 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

Day 4

 Conducting GCP Audits

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

Day 5

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
  • Key findings from recent cases
  • Types of problems and possible preventive actions
  • Case examples of misconduct and fraud