2023 RSNA Clinical Trials Methodology Workshop January 7 – 13, 2023 Coronado Island Marriott Resort & Spa San Diego, California The Society of Interventional Radiology Foundation (SIRF) provides up to four travel awards for selected interventional radiology participants (sponsored applicants must be SIR members.)
LEARNING OBJECTIVES and FINANCIAL DISCLOSURE STATEMENT
WORKSHOP AGENDA
INSTRUCTIONS FOR THURSDAY EVENING POSTER SESSION
2023 CTMW FACULTY & BIOS
2023 STUDENT CATALOG
PRE-COURSE REQUIREMENT - CHECKLIST PRE-COURSE RECOMMENDED READING ELIGIBILITY CRITERIA EXAMPLES	SUPPLEMENTAL BIBLIOGRAPHY STATISTICAL CONCEPTS SERIES FUNDAMENTALS OF CLINICAL RESEARCH FOR RADIOLOGISTS
CTMW 2023 STUDENTS	CTMW 2023 FACULTY

Templates and Sample Documents

Guided version (Detailed Instructions Included)

· Diagnostic Imaging Protocol Template

· Imaging Therapy Trials Protocol Template

· Schedule of Activities Template

Informed Consent

· Template for Basic Elements of Informed Consent

· Informed Consent Requirements Overview

· Checklist for Informed Consent from the National Cancer Institute Web page

The following are samples of protocols from previous Workshops:

· Sample 1 Protocol from 2007 Workshop	· Sample 4 Protocol from 2014 Workshop
· Sample 2 Protocol from 2008 Workshop	· Sample 5 Protocol from 2015 Workshop
· Sample 3 Protocol from 2011 Workshop

Other Resources

· Database Schema Templates

· ACRIN Adverse Event Reporting Manual

· Inclusion/Exclusion Criteria for National Cancer Institute (NCI)

· From RECIST to PERCIST: Evolving Considerations for PET Response Criteria in Solid Tumors

· Pointers to Relevant FDA Guidance’s:

o Devices:

· Medical Imaging Technologies

· Medical Device Guidance Documents

· Investigational Device Exemption (IDE)

o Drugs (e.g., contrast agents):

· Medical Imaging and Drug Development

· Investigational New Drug (IND)

· Exploratory IND (xIND)

Miscellaneous

· Trivia Day 1

· Trivia Day 2

· Trivia Day 3

· Comment Form