Phase I trials require an additional monitoring skill set. The Clinical Research Associate (CRA) assessment focus changes in many monitoring practices, from the Informed Consent Form to data review of PK sampling. Most CRA trainings do not test or provide practicum for the unique focus of a Phase I trial. This web seminar will identify the differences in skills and review specific components for monitoring studies in this phase of research. References from GCP to support monitoring activities will be presented, as well as case studies to apply presented concepts.
- Identify the importance of Pharmacokinetics (PK) and timed blood drawing
- Describe the differences between Phase I research sites and others
- Distinguish Phase I monitoring activities from other types of trials
- Describe safety monitoring in Phase I trials
- Recognize common compliance issues at Phase I research sites
- Identify additional essential document requirements
- Discuss appropriate GCP references to support Phase I monitoring activities
- Clinical Research Associate Managers
- Clinical Research Associates
Daniel Filoramo, R.N., B.S.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 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#: 0778-0000-12-022-L01-P. Released:1/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.