A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
EU Clinical Trial Regulation 536/2014: Trial Management and Monitoring Requirements
Upcoming Courses
Course Description
This web seminar is a targeted overview of sponsor responsibilities for clinical trial management and monitoring under the EU Clinical Trial Regulation (EU CTR) 536/2014 requirements. In addition to reviewing new/revised definitions, this web seminar reviews the following requirements: Low interventional clinical trials, concerned member state reporting (trial start, first trial visit-first subject, end of recruitment, etc.), substantial modification, informed consent (e.g., cluster trials, emergency situations, vulnerable populations), investigator/principal investigators, risk adapted approaches for trial monitoring, serious breach reporting, reporting third country inspections, clinical trial master file (TMF), to name a few. Recommended approaches, benchmarks/industry standards to achieve compliance will also be discussed.
Learning Objectives
- Identify two requirements impacting site monitoring
- Identify two requirements impacting trial management
- Determine three approaches to use in support of compliance with EU CTR 536/2014
Who Should Attend
- Clinical Research Associates/Site Monitors
- Trial Managers
- Clinical Project Managers/Directors
- Clinical Quality Assurance/Compliance Personnel
Instructor
Jarrard Mitchell, M.B.A., CQA.
Click here for complete trainer biographies
Registration Fees
$1,045
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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Accreditation Information
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 4 hours (0.4 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-17-081-L01-P. Released: 3/17.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
