The UTHSC Tennessee Clinical and Translational Science Institute (TN-CTSI) and Office of Clinical Research Development (OCRD) will offer basic research training by Zoom. The course, Research 101, will be a series of eleven 1 to 1.5-hour lectures from 11:30 am to 1:00 pm on Tuesdays and Thursdays beginning May 21, 2020 and ending June 25, 2020. Classes will be taught by experts from UTHSC and affiliates locally and across the state. The course is designed for new investigators, research staff and coordinators, and anyone who wants to learn more about research study conduct.
You will need to register for each session individually. Look for registration information in the days and weeks to come.
5/21/2020 Session 1: Research History and Background, Evolution of Regulations and Guidance
Janie Gardner, MS, CCRP, CIM
5/26/2020 Session 2: Phases of Clinical Research and Study Types
Janie Gardner, MS, CCRP, CIM
5/28/2020 Session 3: Good Clinical Practice, ICH Guidelines, Compliance, FDA Regulations
Derita Bran, MSN, RN, CCRP
6/2/2020 Session 4: Standard Operating Procedures
Marie Jackson, PhD, MBA
6/4/2020 Session 5: Role and Responsibilities of the IRB, Sponsor, CRO, Principal Investigators, and Key Study Personnel
Derita Bran, MSN, RN, CCRP
6/9/2020 Informed Consent / Assent and Documentation of the Informed Consent Process
Margaret Lynn, LMSW, RDN, CCRP, CIP
6/11/2020 Session 7: Regulatory and Essential Documents Record-Keeping
Derita Bran, MSN, RN, CCRP
Carol Hendrix, MSN, RN, CCRC
6/16/2020 Session 8: Source Documentation
Kerry Moore, R.N.
6/18/2020 Session 9: Event Reporting—SAE’s, AE’s, Deviations and Other Events
Carrie Palmer, MSN, RN
6/23/2020 Session 10: Investigational Product Handling and Record-Keeping
Jan Orga, RN
6/25/2020 Session 11: Monitoring Visits and Audits
Jennifer Burgess, MS
Research 101 Faculty:
Derita Bran, MSN, RN, CCRP
Program Director
TN-Clinical and Translational Science Institute
University of Tennessee Health Science Center
Memphis, TN
Jennifer Burgess, MS
Director, Clinical Research
Erlanger Health System
Chattanooga, TN
Janie Gardner, MS, CCRP, CIM
Clinical Research Development, Office of Research
University of Tennessee Health Science Center
Memphis, TN
Carol Hendrix, MSN, RN, CCRC
Research Nurse Manager
Biorepository and Integrative Genomics Initiative
University of Tennessee Health Science Center at Le Bonheur Children’s Hospital
Children’s Foundation Research Institute
Memphis, TN
Marie Jackson, PhD, MBA
Senior Director
Children’s Foundation Research Institute,
Le Bonheur Children’s Hospital
Memphis, TN
Margaret Lynn, LMSW, RDN, CCRP, CIP
Director, Office of Clinical Research Development
University of Tennessee Health Science Center
Memphis, TN
Kerry Moore, R.N.
Director, Clinical Research
Children’s Foundation Research Institute
Le Bonheur Children’s Hospital
Memphis, TN
Carrie Palmer, MSN,
Clinical Research Coordinator Team Leader
Office of Clinical Trials
University of Tennessee Medical Center
Knoxville, TN
Jan Orga, RN
Manager, Clinical Research
Saint Thomas Research Institute
Nashville, TN