Center for Professional Innovation & Education, Inc., Malvern, PA
July 23 & 24, 2014
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
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.
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