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Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments
IRB Standard Operating Procedures
AHRQ: Mandatory Use of Data Safety and Monitoring Plans
Payment to Research Participants
Clinical Trials with No/Low Enrollment: Guide for Departments
CBR Use Proposal Form
Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources
Data & Biospecimen Sharing Checklist
Statement of Practice: Remote Study Procedures
Secondary Use Research

Off-Label Use

A drug prescribed for conditions other than those approved by the FDA. The off-label use of a marketed drug in the course of medical practice does not in and of itself constitute investigational use of a drug, unless that use is part of an experiment or systematic investigation meeting the criteria for human subject research.