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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

Investigational Device

A device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Devices are classified as significant and non-significant risk. A significant risk device means an investigational device thatpresents a potential for serious risk to the health, safety, or welfare of a subject. (FDA)