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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

Relatedness (Adverse Events)

An assessment regarding the causal relationship between a drug or intervention and an adverse event.

EVENTS RELATED

Definitely Related  

  • The event is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
  • The event follows an obvious sequence of time, from the drug’s administration, device’s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure.
  • The event ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting).
  • The event includes data that was only collected for the study.
  • The event included disturbing or upsetting questions that the subject was asked for the purpose of the research.

Probably Related

  • The event is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
  • The event follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure.

Possibly Related

  • The event is a lesser known or possible effect of the drug, device, or procedure.
  • The event occurred within a sequence of time from the drug’s administration, device implantation and/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event could be explained by the characteristics of the population under study.

EVENTS NOT RELATED 

Unlikely Related

  • The event is NOT a previously known or suspected effect of the test drug, device, or procedure.
  • The event 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.
  • The event can be readily explained by the characteristics of the population under study.

Unrelated

  • The event is NOT known to be an effect of the test drug, device, or procedure.
  • The event 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.
  • The event can be readily and easily explained by the characteristics of the population under study.
  • Subject never received study drug, study device, or underwent research study procedure.