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Previous Sessions

Research 101

Research 101: a series of eleven lectures offered in May/June 2020. The course was 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. 

Session 1

Research History and Background, Evolution of Regulations and Guidance
Janie Gardner, MS, CCRP, CIM

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Session 4

Session 4: Standard Operating Procedures
Marie Jackson, PhD, MBA

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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 10

Investigational Product Handling and Record-Keeping
Jan Orga, RN

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Session 2

Phases of Clinical Research and Study Types
Janie Gardner, MS, CCRP, CIM

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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 8

Source Documentation
Kerry Moore, RN, BS, CCRC

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Session 11

Monitoring Visits and Audits
Jennifer Burgess, MS

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Session 3

Good Clinical Practice, ICH Guidelines, Compliance, FDA Regulations
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 9

Event Reporting—SAE’s, AE’s, Deviations and Other Events
Carrie Palmer, MSN, RN

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Last Published: Sep 21, 2020