Minnesota Chapter: Electronic Trial Files

Electronic Trial Files

Speakers

• Jodi Mullin, Principal Clinical Research Associate, NAMSA
• Jamie Seiffert, Senior Clinical Research Associate, NAMSA
• Kasie Onken, Principal Clinical Research Asssociate, NAMSA
• Julia Brenner, Financial and Regulatory Manager, Coastal Pediatrics Associates

Target Audience

• CRCs
• CRAs
• Project Managers
• Regulatory Affairs/Compliance
• Data Managers (Site, Sponsor, CRO)
• Quality Assurance
• Other

Program Description
Electronic Trial Files are becoming more and more prevalent in Clinical Research. But are they a help or hindrance? Join us in learning more about the systems, system demos, their implementation as well as how they are used in routine conduct of a clinical trial. We will explore when the pros and cons of their use as discussed from a site and CRO/sponsor's perspectives.

Program Agenda
6:00-6:30pm registration and dinner
6:30-8:00pm Presentation from the site and CRO/sponsor perspective
8:00--8:30pm Panel Discussion

Learning Objectives 

1. Understand what an eTMF and eRegulatory system is
2. Understand how to work with the eTMF or eRegulatory system through the start-up, validation, maintenance, and close-out phases of a study
3. Evaluate the applicability of eTMF and eRegulatory systems versus paper trial binders
4. Analyze the advantages and challenges associated with an eTMF or eRegulatory system

Registration information:

• Chapter Members
  • In-Person Only - $0
  • In-Person with Contact Hours - $0
  • Virtual Only - $0
  • Virtual with Contact Hours - $0
• ACRP Members
  • In-Person Only - $30
  • In-Person with Contact Hours - $45
  • Virtual Only - $20
  • Virtual with Contact Hours - $35
• Non-Members
  • In-Person Only - $60
  • In-Person with Contact Hours - $90
  • Virtual Only - $45
  • Virtual with Contact Hours - $75

Contact Hours: 1 contact hour have been applied for through ACRP. Membership is not required for online registration of contact hours.

To Receive Contact Hours: Purchase the contact hours, sign in at the registration desk and attend the program. Log on to the ACRP website and go to “Access My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Refund/Cancellation: If you need to cancel your registration, please notify the Programming Committee as soon as possible but no later than 24 hours prior to the event for a full refund. Email acrpmnchapter@gmail.com to cancel and request a refund.