Showing results for IRB

Revised FDA Draft Guidance on Charging for Investigational Drugs
The U.S. Food and Drug Administration (FDA) issued a revised draft guidance, entitled Charging for Investigational Drugs Under an IND Questions and An...
Participatory Science and the Institutional Review Board
Presented by: Lisa M. Rasmussen, PhD – University of North Carolina at Charlotte Learning Objectives: Describe the meaning of participatory ...
Illegal Activities or Undocumented Status in Human Research
Provides training and insight to researchers, administrators, and institutional review boards (IRBs) regarding added risks and challenges of conductin...
Equitable Selection of Subjects
This scenario examines how IRB reviewers and investigators could apply the concept of equitable selection of subjects in research. It takes approximat...
Research Involving Subjects at the End-of-Life
Persons at the end of life may be vulnerable for numerous reasons, including cognitive and physical impairments, which may progress as death approache...
Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
Defines unanticipated problems, describes the reporting requirements associated with unanticipated problems, and identifies the types of actions an In...
Congratulations to Susan Z. Kornetsky, MPH, 2019 ARENA Legacy Award Recipient
CITI Program would like to congratulate PRIM&R's 2019 ARENA Legacy Award recipient, Susan Z. Kornetsky, MPH, Senior Director of Clinical Research ...
Balancing Risks and Benefits
This scenario discusses what IRBs may consider as anticipated benefits of research and whether they may be reasonable against the research risks indiv...
FDA Issues Guidance For Clinical Research Using Cannabis
The FDA has issued guidance detailing the FDA’s current thinking on clinical research with cannabis and cannabis-derived compounds. It includes qual...
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