I'm looking for information about

Can't find what you're looking for? You may need to login to see more documents.

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
Michigan Medicine Clinical Research Position Statement
Guidelines for Studies Conducted Through MCOHR and the Dental School

Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO / UaP)

Often referred as an Unanticipated Problem. An unanticipated problem may be either an actual harmful or unfavorable occurrence or any development that potentially increased the likelihood of harm occurring in the future. Assessment Criteria:

  1. Unanticipated Severity: The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.
  2. Related: There is a reasonable possibility that the procedures involved in the research caused the problem.
  3. Increased Risk: The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).