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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

Unrelated Adverse Event

An adverse event that

  • is NOT known to be an effect of the test drug, device, or procedure
  • does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure
  • can be readily and easily explained by the characteristics of the population under study
  • involves a subject who never received study drug, study device, or underwent research study procedure

Related Terms: Relatedness (Adverse Events) / Cause /