The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

Course Description

Strategies for saving time and money, without compromising oversight and quality, are an ongoing challenge within the industry. In an age where technology is ever present from ordering medications online, consulting with a physician, and having “live” conversations in chat rooms about medical issues, the clinical research industry has been slow to maximize the use of technology. With sponsors/CROs implementing the FDA’s final guidance on a risk-based approach to monitoring, time on site is being reduced to one day visits and/or on-site visits are scheduled few and far between per monitoring plans. Better utilization of remote monitoring is critical to ensure sites are compliant and the data is accurate and consistent. During this web seminar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what “red flags” to look for that may indicate issues on site.

Learning Objectives

• Describe approaches and techniques for remote data review
• Explain techniques for query writing to ensure clear communication of issues
• Implement strategies to identify problem areas and how to maximize time on site following remote monitoring

Who Should Attend

• Study Coordinators
• Clinical Research Associate Managers
• Clinical Research Associates
• Project Managers

Instructor

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.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#: 0778-0000-24-015-L99-P. Released: 2/24. 

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