Research 101, 102, and 103
BASIC RESEARCH TRAINING
Research 101
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
Role and Responsibilities of the IRB, Sponsor, CRO, Principal Investigators, and Key Study Personnel
Derita Bran, MSN, RN, CCRC
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Informed Consent / Assent and Documentation of the Informed Consent Process
Margaret Lynn, LMSW, RDN, CCRP, CIP
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