Pacific Northwest: Regulatory Considerations for 21st Century Paperless Trials (Webinar)

Regulatory Considerations for 21st Century Paperless Trials (Webinar)

Program Agenda:

• 5:30 – 6:00 PM – Registration & Networking
• 6:00 – 6:45 PM – Webinar Replay
• 6:45 – 7:30 PM – Discussion and Networking

Registration Cost:

• $5 Chapter Members
• $10 ACRP Members
• $20 Non-Members

Program Description: The FDA and other regulatory bodies have issued multiple guidance documents addressing requirements when using technology tools to execute paperless clinical trials. The push from the regulatory agencies has occurred despite a risk-averse pharmaceutical industry, still comfortable living in a “paper world.” This risk aversion is in part due to an irrational fear by sites and sponsors of receiving a FDA Form 483 when an FDA inspector discovers, for example, that a patient was born in 1982, when in the study database it is recorded as 1983, even when there is no impact on the study results. Additionally, the clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.

Upon completion of this event, attendees should be able to:

• Understand the future landscape of paperless clinical trials
• Understand regulatory concerns when running paperless clinical trials
• How to “separate toys from tools” when choosing mobile and related devices

Target Audience: Clinical Research Coordinators, Project Managers, Quality Assurance and Compliance and Regulatory Affairs staff.

For additional information contact Angela LeClair at angelachein@hotmail.com or 206-658-3146.

Date: June 5th 2018

Time: 5:30 – 7:30 PM

Location:
EvergreenHealth Medical Center
Red 1-551 Auditorium
12040 NE 128th St
Kirkland, WA 98034

Contact hours: 1.0 contact hour has been applied for through ACRP. Membership is not required for online registration of contact hours.

3 Steps to receive contact hours:

• Purchase the contact hours on the ACRP website when you register.
• Sign in at the registration desk and attend the program.
• After the event, log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:

• $0 Chapter Members
• $15 ACRP Members
• $30 Non-Members

Refund Policy: No refunds

Level: Moderate