August 2024 SOCRA Source Journal - Journal - Page 2
TABLE OF
CONTENTS
PRESIDENT’S MESSAGE ....................................................... 4
SOCRA INFORMATION
BOARD OF DIRECTORS .........................................................5
SELF-STUDY OPPORTUNITY
2024 ANNUAL CONFERENCE
Informed Consent: Guidance for IRBs,
Clinical Investigators, and Sponsors ....................................... 6
Self Study Questions ............................................................. 16
Self Study Answers ................................................................ 24
JOURNAL ARTICLES
How to Restore Order to the Daily Chaos and
Amplify the Clinical Research Site’s Voice to Sponsors
Ted Trafford, Director of Business Development,
Probity Medical Research
Mike Wenger, Founder & CEO, VersaTrial................................. 19
Investigator-Initiated Research from Start to “Audit”
Erica M. Weidler, MEd, MA, CCRC ........................................... 25
Clinical Trial Operations: From Mouse Models
to the Market
Tia L. Patterson, Ph.D., CCRP .................................................... 33
Triple Negative Breast Cancer and STAT Proteins Family
Emily B. Smith and Ryan T. Richmond,
Thermo昀椀sher Scienti昀椀c, Lenexa, KS .......................................... 43
Turning Back Time: Clinical Trials Investigate Genome
Editing for Anti-Aging
Deepika Khedekar, Clinical Trial Lead, IQVIA ............................ 55
Project Management Tips and Tricks for Launching a
Successful Research Project
Emily Hardwick, MPH, CCRP, PMP ............................................ 59
2
SOCRA SOURCE © May 2024
33rd Annual Conference Announcement .... 32
2024 Poster Program Guidelines ................. 70
CLINICAL TRIALS DAY
Information .................................................. 32
2024 Nominees ........................................... 70
CHAPTER PROGRAM
Chapter Contacts ........................................ 71
CERTIFICATION ............................... 76-78
Eligibility ...................................................... 78
Maintaining Certi昀椀cation ............................. 78
CONFERENCES AND WORKSHOPS
Online Educational Programs.......................80
Clinical Research Monitoring Workshop...... 81
Advanced Site Management:
Finance & Productivity Workshop................ 82
Certi昀椀cation Prep & GCP Review Course .... 83
FDA Clinical Trials Requirements ................. 84
Human Research Protections....................... 85
Site Coordinator / Manager Workshop ....... 86
Clinical Research Nursing Conference ........ 87
Project Management Workshop .................. 88
Device Conference ...................................... 89
Emergency Clinical Research Symposium ... 90
Quality Management Conference ............... 91
Educational Opportunities .......................... 92
ADVERTISING OPPORTUNITIES
Print and Web Advertising .......................... 93