Industries: Pharma / BiotechMedical Device

Risk-Based Monitoring and GCP Compliance in Pharmaceutical, Biologic and Medical Device Clinical Trials

Course Director: Michael R. Hamrell, Ph.D.

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 - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This GCP compliance training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. The FDA supports clinical trial sponsors to use risk-based site monitoring. That's a plus for many sponsors, but you have to have the quality risk management system in place to make it work. 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. This will include practical knowledge on how to implement a risk-based monitoring approach to quality in clinical trials.

Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites by maximizing risk-based considerations. 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.

Who Should Attend

This two-day course will benefit those involved in the monitoring and/or QA of clinical trials. Employees who work for Pharmaceutical or Biological 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.

Course Agenda

First Day

Defining the Basic Requirements of GCP

  • Terminology
  • Overview of clinical compliance laws
  • FDA, ICH GHTF and ISO requirements
  • Other global considerations
  • Understanding the role of the FDA, OHRP and IRBs
  • How the GCP guidelines helps in good studies
  • Difference in requirements for drugs vs. devices
  • Group discussion of interpreting regulatory requirements for GCP

Human Subject Protection and Informed Consent Requirements

  • Role of the IRB in clinical studies
  • 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 for SOPs in clinical research for GCP compliance?
  • Interpret and apply international GCP standards
  • How good SOPs help avoid 483s and speed up the process

How to Monitor the Site

  • Defining the difference between auditing and monitoring
  • Risk-based Monitoring
  • What are the big items that must be in place
  • Common problems
  • Pointing out site performance deficiencies
  • Identifying solutions to deficiencies

Electronic Systems and Data Management

  • Complying with 21 CFR Part 11
  • FDA guidance on electronic systems
  • Issues with electronic data capture, CRFs and medical record systems

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

Second Day

Defining Investigator Responsibilities

  • Role of the Principal investigator
  • Role of the Clinical Research Coordinator
  • Record keeping requirements and documentation
  • Importance of Laboratory data
  • Importance of Drug accountability

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
  • CRFs vs. eCRFs
  • How much clinical data is enough
  • Making sure your records and reporting are accurate

Preparing for FDA Inspections

  • Preparing for the visit
  • FDA criteria for selecting sites for inspection
  • Source documentation: How much is enough?
  • Common GCP deficiencies
  • Review potential roadblocks of non-compliance
  • Recent BIMO inspection results
  • 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

Learning Objectives

By the end of this course, participants will have a detailed understanding of how to:

  • Identify and define the principles and requirements for GCPsDefine the roles and responsibilities of sponsor, monitor,
  • investigators and FDA as they relate to the quality of clinical trials
  • Recognize clinical trial documentation differences for drug, device, and biologic studies
  • Define risk-based monitoring and how to implement plans and maximize the quality in a risk-based environment
  • Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
  • Understand what happens during a GCP inspection
  • Detect and prevent fraud and misconduct in clinical trials
  • Ensure that your data and supporting documentation are accurate and in the right format for inspectors


"Great course! Material extremely comprehensive and the course trainer was clearly well-trained." Lar H., Director, Yale University
"Dr. Hamrell was extremely knowledgable and able to view the topics and questions from several perspectives - researcher, inspector, monitor, investigator and team. Excellent, lucid, and thorough. Very appropriate for all audiences - coordinators, investigators, IRB and QA professionals." Susan A., Director of QA and Training, Yale University
"This course was very informative - lots of great information and areas to consider. Great food for thought in the details of clinical trials in terms of monitoring and auditing. Great insight and requirement specifics and how they can be implemented within the institution." Terri L., RN BSN, Yale University
"Discussions were great. Loved the examples of warning letters. Notes were clear and not too wordy - thank you! Will highly recommend this course to my coworkers. Fun atmosphere made learning and understanding Easy!" Julie R., Clinical Research Engineer, K2M
"The Course Director was very knowledgeable about the course subject. Reading existing examples from the FDA audit was very useful. This was one of the better courses I have been to, and I will recommend this course to my colleagues." Ainars S., Project Manager, JSC Grindeks
"The Course Director was extremely knowledgeable and was able to convey that knowledge to the class. He didn't talk over us, but to us." Susan T., Senior Manager, Clinical Research, Cephalon
"The course director was an outstanding choice for an instructor for this course. He instills confidence that CfPIE has its fingers on the pulse of national & international regulatory & GCP compliance issues." Paul L., Director, Research Operations, New Health Sciences
"The course director was extremely knowledgeable about the course subject. I will definitely recommend this course to others." Sue B., Clinical Documentation Coordinator, Sanofi Pasteur
"The Course Director was very engaging. He is very knowledgeable in all aspects of clinical study monitoring and answered all of the questions asked. I feel much better knowing some background on this topic." Elizabeth W., Clinical Applications Specialist, Cochlear Americas
"The course material presented new ideas and added to my knowledge. I would strongly advise those in QA monitoring to attend this training. This course provided me with opportunities for improvement in my job as a QA Coordinator." Sawsan A., Quality Assurance Coordinator, MU-JHU
"Great Instructor! Covered a tremendous amount of information, yet I never felt we were rushing through the material. All questions were addressed with the level of expertise that clearly shows the band of his knowledge in the area." Joyce C., President, Chiarenza Consulting
"The Course Director is very knowledgeable in the area of GCP compliance. I am confident in my ability to monitor clinical trials within the realm of GCP Compliance. I enjoyed the course and will more than likely attend more seminars provided by CfPIE. Thank You!" Brandi S., Transitional Medicine Specialist, Pharmion
"This course was immensely informative and applicable toward my job. Thank you, I appreciate the organization and development of the course." Jasmine S., Clinical Trial Coordinator, IMGOS
"This was an excellent course. The instructor provided a very good overview of the clinical trial compliance process that was beneficial to all attendees." Bill G., Project Manager, Upsher-Smith Labs

Frequently Asked Questions

What does Monitoring mean for clinical trials?

Monitoring is the ongoing process of overseeing a study to ensure patient safety, data quality, protocol compliance, and regulatory compliance. It includes all of the activities performed to assure the quality of the study data and safety and integrity of the conduct and the subjects involved in the study.

Is a company required to perform 100% monitoring or SDV for a study to be acceptable to FDA?

The FDA has never required a company perform 100% monitoring or source data verification (SDV) of the study data. This was a standard developed as an industry practice to assure the highest quality data. This was started at a time before the use of computers and electronic technology to assist with the assurance of quality data. Many alternatives to performing 100% SDV that can also provide high quality data and a complaint study.

How is remote monitoring performed and what does this mean?

Remote monitoring includes all of the processes and systems we use to oversee the performance and quality of the study data. It does not mean you sit in your office and do the same activities you used to do on site from a remote location. Remote monitoring encompasses a different set of tools and approaches to assure the quality of the study data, including the use electronic technology to assist in the process, coupled with some source data verification.