This course is designed for Clinical Research Associates (CRAs) currently working in the industry who are interested in gaining knowledge about monitoring in the oncology therapeutic area. As the demand for CRAs in the oncology arena continues to grow, this course offers practical, hands-on training covering oncology-specific logistical, clinical, and ethical considerations. The application of clinical monitoring skills to oncology trials is reinforced through interactive discussions, case studies, and practice-based activities. The course content is also valuable to Project Managers and CRA Managers working in the oncology field as they seek to design feasible protocols, clinical monitoring plans, and monitoring tools adaptable to the unique requirements of these study sites and trials.
- Manage challenges with infrastructure and delegation of authority at oncology sites
- Describe common characteristics of Institutional Review Board (IRB) review and communications in oncology trials
- Facilitate decision-making at sites for dosing toxicities and dose modifications in oncology trials
- Apply standardized grading criteria to adverse events in oncology studies
- Utilize appropriate oncology disease progression algorithms
- Address common challenges in managing laboratory and biomarker samples in oncology studies
- Establish strategies to identify and obtain appropriate source documentation at oncology sites
- Develop plans for thorough and efficient oncology monitoring visits
- Clinical Research Associate
- Clinical Research Associate Manager
- Clinical Operations and Trial Management Personnel
- Project Managers
The course will be led by one of the following instructors:
Karen L. Gilbert, B.S., C.C.R.A.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Oncology Sites and Infrastructure for Monitors
- Ethical Considerations in Oncology Clinical Trial Monitoring
- Managing Investigational Products and Dosing in Oncology Clinical Trials
- Adverse Event Management and Reporting in Oncology Clinical Trials
Day 2: 8:30 a.m. – 5:00 p.m.
- Tumor and Disease Progression Assessments for Monitors
- Laboratory and Biomarker Management for Monitors
- Source Data Verification in Oncology Clinical Trials
- Monitoring Tools and Best Practices in Oncology Clinical Trials
- Scenario: Managing the Complexity of Oncology Site Infrastructure
- Case Studies in Oncology Dosing Toxicity Management
- Activity: Identification and Toxicity Grading of Adverse Events
- Simulation: Tumor/Disease Progression
- Critique: Adequate and Complete Source Documentation
- Scenario: Planning the Monitoring Visit
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-16-018-L01-P. Released: 3/16.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.