Dates:
Monday, November 24, 2025; Session 1 of 5
Monday, December 1, 2025; Session 2 of 5
Monday, December 8, 2025; Session 3 of 5
Monday, December 15, 2025; Session 4 of 5
Monday, December 22, 2025; Session 5 of 5
Time: 4 to 5 p.m. MST
Location: Virtual via Zoom
You must register for each session individually; login information will be sent to you after registration for the event.
Registration: Click here*
*Note: Use this link each time to register for individual sessions.
Name and Title of Speaker: Rachel Kingsford, MS, CCRP; Senior Clinical Research Program Manager
Speaker’s Affiliation: Huntsman Cancer Institute Clinical Trials Office
Objectives:
Monday, November 24 | Session 1:
• Review ethical principles related to clinical research
• Discuss details of informed consent requirements
• Provide an overview of ICH E6 R3 updates regarding informed consent
Monday, December 1 | Session 2:
• Discuss drug development process
• Discuss clinical trial protocol elements and amendments
• Review safety reporting requirements
Monday, December 8 | Session 3:
• Provide an overview of IRB purpose and structure according to the regulations
• Discuss the responsibilities of the IRB/IEC
• Discuss the responsibilities of the investigator
Monday, December 15 | Session 4:
• Discuss the elements of device research
• Provide an overview of the sponsor’s roles and responsibilities
• Provide an update on the ICH E6 R3 addition of data governance
Monday, December 22 | Session 5:
• Discuss study closure, record retention requirements, and essential documents
• Provide examples of research misconduct
• Review of audit and FDA inspection procedures
SOCRA CEUs available: 1 CE/per session for SOCRA members. Only SOCRA members receive a certificate of attendance.
Questions: Please contact Rachel Kingsford (801-585-0115; utahsocra@gmail.com)
Registration: Click here*
*Note: Use this link each time to register for individual sessions.
SOCRA members and non-members are welcome!