Course Description

Understanding the big picture of how essential study documents impact the approval and ethics of a clinical research trial often gets overlooked in the rush of document collection and requests. The foundation of this web seminar is the site study file, what the documents are, and why they are important as related to the ICH GCP E6 Guideline Essential Documents and 21 CFR 50, 54, 56 and 312. This web seminar will also provide a reference point for why the paperwork is so critical within the process of a study.

Learning Objectives

• Describe the investigational product development process and the role of documentation
• Discuss the roles and responsibilities during the study document handling process
• Review the importance of study files and essential documents handling including review of FDA audit findings

Who Should Attend

• Study Coordinators
• Site Regulatory Managers
• Clinical Research Associates
• Project Assistants
• Regulatory Assistants
• Site Managers

Instructor

Marla Hoelle, B.S.N., R.N., C.C.R.A., ACRP-PM., P.M.P.

Click here for complete trainer biographies

Registration Fees

$735

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.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 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#: 0778-0000-18-056-L01-P. Released: 7/18. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.