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Basic Research Training

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:

Research History and Background, Evolution of Regulations and Guidance

Janie Gardner, MS, CCRP, CIM

View Powerpoint  or Watch Presentation

Session 2:

Phases of Clinical Research and Study Types

Janie Gardner, MS, CCRP, CIM

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Sesson 3:

Good Clinical Practice, ICH Guidelines, Compliance, FDA Regulations

Derita Bran, MSN, RN, CCRC

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Session 4:

Standard Operating Procedures

Marie Jackson, PhD, MBA

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Session 5:

Role and Responsibilities of the IRB, Sponsor, CRO, Principal Investigators, and Key Study Personnel

Derita Bran, MSN, RN, CCRC

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Session 6:

Informed Consent / Assent and Documentation of the Informed Consent Process

Margaret Lynn, LMSW, RDN, CCRP, CIP

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Session 7:

Regulatory and Essential Documents Record-Keeping

Derita Bran, MSN, RN, CCRC Carol Hendrix, MSN, RN, CCRC

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Session 8:

Source Documentation

Kerry Moore, RN, BS, CCRC

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Session 9:

Event Reporting—SAE’s, AE’s, Deviations and Other Events

Carrie Palmer, MSN, RN

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Session 10:

Investigational Product Handling and Record-Keeping

Jan Orga, RN

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Session 11:

Monitoring Visits and Audits

Jennifer Burgess, MS

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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.

Session 1:

Effective Communication, Leadership and Professionalism

Sally Badoud, AVC Communications and Marketing, UTHSC

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Session 2:

Subject Recruitment

Margaret Knack, RN, MS, CCRP – Research Director, The Campbell Foundation (Memphis, TN)

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Session 3:

FDA Audits and Common Findings

Jennifer Burgess, MS – Director, Clinical Research, Erlanger Health System (Chattanooga, TN)

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Session 4:

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

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Session 5:

Confidentiality/Privacy/HIPAA

Kim Prachniak, MS, CIP – Associate Director, Institutional Review Board, UTHSC

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Session 6:

Advanced Consent Issues

Margaret Lynn, LMSW, RDN, CCRP, CIP – Director, Office of Clinical Research Development, UTHSC

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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.

Session 1:

How to Develop Power Point Presentations and Other Effective Communication Tools

Sally Badoud – AVC, Communications and Marketing, UTHSC

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Session2:

Research Contracts and Agreements

Sarah J. White, MA, EdM – AVC, Office of Sponsored Programs, UTHSC

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Session 3:

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

View Powerpoint 1, View Powerpoint 2 or Watch Presentation

Session 4:

Protocol and Study Measures Training– The Importance of Accuracy and Consistency

Misty Thompson, PhD, CCRP – Clinical Research Associate, Penumbra, Inc.

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Session 5:

Diversity and Inclusion in Research  

Mona Wicks, PhD, RN, FAAN – Professor and Chair, Health Promotion and Disease Prevention, UTHSC College of Nursing

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Session 6:

Scientific Integrity and Preventing Research Misconduct

Mark A. Miller, PhD – Research Integrity Officer and Associate Professor, UTHSC College of Medicine

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