The UTHSC Tennessee Clinical and Translational Science Institute (TN-CTSI) and the Office of Clinical Research Development (OCRD) offers basic research training via Zoom. Classes are taught by experts from UTHSC and affiliates locally and across the state.
RESEARCH 101
This series of 11 lectures provides basic research training. The course was designed for new investigators, research staff and coordinators, and anyone who wants to learn more about research study conduct.
- Session 1
- Session 2
- Session 3
- Session 4
- Session 5
- Session 6
- Session 7
- Session 8
- Session 9
- Session 10
- Session 11
Research History and Background, Evolution of Regulations and Guidance
Janie Gardner, MS, CCRP, CIM
Good Clinical Practice, ICH Guidelines, Compliance, FDA Regulations
Derita Bran, MSN, RN, CCRC
Standard Operating Procedures
Marie Jackson, PhD, MBA
Role and Responsibilities of the IRB, Sponsor, CRO, Principal Investigators, and Key Study Personnel
Derita Bran, MSN, RN, CCRC
Informed Consent / Assent and Documentation of the Informed Consent Process
Margaret Lynn, LMSW, RDN, CCRP, CIP
Regulatory and Essential Documents Record-Keeping
Derita Bran, MSN, RN, CCRC Carol Hendrix, MSN, RN, CCRC
Event Reporting—SAE’s, AE’s, Deviations and Other Events
Carrie Palmer, MSN, RN
Investigational Product Handling and Record-Keeping
Jan Orga, RN
RESEARCH 102
A series of 6, 1-hour lecture, this course builds upon the basic research training provided in Research 101 (which was offered May through June of 2020). Research 102 addresses more advanced issues pertaining to study conduct but can be taken without having previously completed Research 101. Offered in September, 2020, Research 102 was designed for investigators, research staff, coordinators, and anyone who wants to learn more about research study management.
Effective Communication, Leadership and Professionalism
Sally Badoud, AVC Communications and Marketing, UTHSC
Subject Recruitment
Margaret Knack, RN, MS, CCRP – Research Director, The Campbell Foundation (Memphis, TN)
FDA Audits and Common Findings
Jennifer Burgess, MS – Director, Clinical Research, Erlanger Health System (Chattanooga, TN)
Creating Site Worksheets/Visit Checklists
Derita Bran, MSN, RN, CCRC – Program Director, TN-CTSI
Carol Hendrix, MSN, RN, CCRC – Research Nurse Manager, Biorepository and Integrative Genomics Initiative, UTHSC at Le Bonheur Children’s Hospital
Confidentiality/Privacy/HIPAA
Kim Prachniak, MS, CIP – Associate Director, Institutional Review Board, UTHSC
Advanced Consent Issues
Margaret Lynn, LMSW, RDN, CCRP, CIP – Director, Office of Clinical Research Development, UTHSC
RESEARCH 103
Research 103 continues advanced research training but can be taken without having previously taken Research 101 and Research 102. A series of six 1-hour lectures presented by experienced researchers from UTHSC and the medical device industry. The course is designed for investigators, research staff, coordinators, and anyone who wants to learn more about research study management.
How to Develop Power Point Presentations and Other Effective Communication Tools
Sally Badoud – AVC, Communications and Marketing, UTHSC
Research Contracts and Agreements
Sarah J. White, MA, EdM – AVC, Office of Sponsored Programs, UTHSC
Using the Research Enterprise Data Warehouse database (EDW) and TriNetX for Subject Recruitment and Using REDCap for Data Capture
Parya Zareie, MS – Data Manager, Center for Biomedical Informatics, UTHSC
Lokesh Chinthala, MS – Informatics Scientist, Center for Biomedical Informatics, UTHSC
Protocol and Study Measures Training– The Importance of Accuracy and Consistency
Misty Thompson, PhD, CCRP – Clinical Research Associate, Penumbra, Inc.
Diversity and Inclusion in Research
Mona Wicks, PhD, RN, FAAN – Professor and Chair, Health Promotion and Disease Prevention, UTHSC College of Nursing
Scientific Integrity and Preventing Research Misconduct
Mark A. Miller, PhD – Research Integrity Officer and Associate Professor, UTHSC College of Medicine