February 2024 SOCRA Source Journal - Journal - Page 2
TABLE OF
CONTENTS
PRESIDENT’S MESSAGE ....................................................... 4
SOCRA INFORMATION
BOARD OF DIRECTORS ........................................................ 5
ANNUAL CONFERENCE
Poster Abstracts...................................... 76-77
SELF-STUDY OPPORTUNITY
Ethical Considerations for Clinical Investigations of Medical
Products Involving Children (Part 2) ........................................ 6
Self Study Questions ............................................................. 11
Self Study Answers ................................................................ 24
JOURNAL ARTICLES
CHAPTER PROGRAM
Chapter Contacts ................................... 78-79
CERTIFICATION ..............................80-82
Eligibility ...................................................... 82
Maintaining Certification ............................. 82
ONLINE COURSES
Online Educational Programs.......................84
Creating a Professional Workplace
Barbara van der Schalie, MS...................................................... 13
Lessons Learned in Establishing an Early Phase
Oncology Program at a Community Research Site
Cindy Stoner, MCR, CCRP ......................................................... 19
ClinicalTrials.gov Protocol Registration and
Results Reporting System Overview
Susan Hmwe, PhD, MBBS, MS, CCRP ....................................... 25
Challenges in Behavioral Research
Involving Children
Muhammad Waseem, MD, MS, CHSE-A................................... 39
A Systematic Review of Factors Hindering
African American Participation in Oncology
Clinical Trials and the Implications on
Representation Through Trial Decentralization
Methods Recommended During SARS-CoV-2
Lee E, Emerson J, Douglass M .................................................. 49
Developing and Maintaining Global Clinical
Evaluation Reports: Best Practices and
Impact of the Medical Device Regulation
and the In Vitro Diagnostics Regulation
Luis Jimenez, RAC and Heyam Kalla ......................................... 63
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SOCRA SOURCE © May 2023
LIVE CONFERENCES AND
WORKSHOPS
Clinical Research Monitoring Workshop.......85
Finance & Productivity Workshop ................86
Certification Prep & GCP Review Course .....87
FDA Clinical Trials Requirements .............88-89
Site Coordinator Workshop .....................90-91
Project Management Workshop ..............92-93
Quality Management Conference ...........94-95
Conducting Clinical Trials in Canada ............96
Human Research Protections........................97
Device Conference .......................................98
Pediatric Clinical Trials Conference ..............99
Clinical Research Nursing Conference .......100
Oncology Clinical Trials Conference...........101
Educational Opportunities .........................102
ADVERTISING OPPORTUNITIES
Print and Web Advertising .........................103