How to Monitor Clinical Trials for GCP Compliance

This course will benefit those involved in the monitoring and/or QA of clinical trials. Employees who work for Pharmaceutical firms, Contract Research Organizations, Medical Device companies and academic institutions involved with the supervision or oversight of clinical trial practices and policies will find this course of interest.

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 sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
• Understand how GCPs can impact clinical research progress and ensure that GCPs are implemented
• Clearly put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
• Ensure that your data and supporting documentation are accurate and presentable for inspection
• Comply with informed consent and Human Subject Protection requirements
• Learn how to detect and prevent fraud and misconduct in clinical trials

Course Description

The course will cover methods to monitor clinical trials for GCP Compliance by:

• Identifying and define the principles and requirements for GCPs
• Define the roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
• Understanding how GCPs can impact clinical research programs
• Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
• Learning how to manage a FDA GCP inspection
• Detecting and preventing fraud and misconduct in clinical trials
• Ensuring that your data and supporting documentation are accurate and in the right format for inspectors

This training course provides a solid understanding of GCP requirements and clinical quality assurance overviews for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches you how to ensure that your data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies.

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COURSE AGENDA

DAY ONE

Defining the Basic Requirements of GCP

• Terminology
• Overview of clinical compliance laws
- FDA and ICH requirements
- 21 CFR Part 11
• Understanding the role of the FDA, OHRP and IRBs
• How the GCP guidelines helps in good studies
• Understanding the roles and responsibilities of the clinical research teams
• Group discussion of interpreting regulatory requirements for GCP

Complying with Informed Consent Requirements

• General requirements of the informed consent
• OHRP role related to Human Subject Protection
• Improving the informed consent process
• Confidentiality of data
• Privacy of subject’s information
• Ethical issues

Ensuring that the SOPs Comply with ICH/GCP Requirements

• What are the requirements of ICH and FDA regulations for GCP
• Interpret and apply international GCP/ICH standards
• How good SOPs help avoid 483s and speed up the process

How to Monitor the Site

• 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

Case study analysis, exercises and quizzes may be administered throughout the course to measure performance improvement.

DAY TWO

Defining Investigator Responsibilities

• Role of the Principal investigator
• Role of the Clinical Research Coordinator
• Recordkeeping requirements and documentation
• Importance of laboratory data
• Importance of drug accountability

Preparing for FDA Inspections

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

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

Managing and Reporting Adverse Events

• Definitions and commonly used terminology
• Reporting requirements from the investigator and sponsor
• Time Frames of Reporting

Collecting, Managing and Reporting Clinical Study Data

• Computerized clinical data management
• CFRs vs. eCFRs
• Complying with 21 CFR Part 11
• How much clinical data is enough
• Making sure your records and reporting are accurate