Utah

“GCP and Research Regulation Overview Seminar Series”

Dates:

• Thursday, October 19, 2023; Session 1 of 5
• Thursday, October 26, 2023; Session 2 of 5
• Thursday, November 2, 2023; Session 3 of 5
• Thursday, November 9, 2023; Session 4 of 5
• Thursday, November 16, 2023; Session 5 of 5

Time: 4:00 to 5:00 p.m.

Location: Zoom

https://utah-health.zoom.us/j/98649677851?pwd=cm9GMWJsWW44WVVHQUk2SERYZnJDQT09

Meeting ID: 986 4967 7851
Passcode: 961309

Name and Title of Speaker: Rachel Kingsford, MS, CCRP; Senior Clinical Research Program Manager
Speaker’s Affiliation: Huntsman Cancer Institute Clinical Trials Office

Objectives:
Session 1:
• Review ethical principles related to clinical research
• Detailed discussion of informed consent requirements
Session 2:
• Discuss drug development and clinical trial protocols and amendments
• Review of safety reporting requirements
Session 3:
• Overview of the responsibilities of the IRB/IEC
• Overview of the roles and responsibilities of the investigator
Session 4:
• Discuss device research
• Overview of sponsor’s roles and responsibilities
Session 5:
• Discuss study closure and records retention requirements
• Review of audits and FDA inspections

SOCRA CEUs available: 1 for SOCRA members. Only SOCRA members receive a certificate of attendance.

RSVP: No RSVP required.
Questions: Please contact Rachel Kingsford (801-585-0115; utahsocra@gmail.com)

SOCRA members and non-members are welcome!