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
1. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
2. 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.
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.
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.