GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials
Course Director
Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
New brochure coming soon!
Future Live Stream Sessions (click to register)
Course Description
This 15 hour 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.
FAQs
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.