Key Points 3-3m

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The following key points should be considered when authoring the procedures section.
  • Explain tasks and procedures from the subject's point of view (what will he or she be expected to do?).
  • Estimate the total amount of time for the person involved in the study.
  • Explain the frequency of procedures.
  • Explain how the person was assigned to groups.
  • Disclose any additional costs or charges for the research procedures with estimated amounts.
  • Describe "randomization" in lay terms.
  • State the probabilities of assignment to each group.
  • For survey/questionnaire studies, state that not all questions need to be answered in order to participate.
  • If the procedures are very complicated or involved, use schema to describe them.
  • Explain if the procedures are experimental. (Required if applicable.)
  • Identify additional procedures due to "research" participation separate from "treatment" procedures.
TREATMENTRESEARCH
PatientSubject
BenefitsAdditional benefit?
RisksAdditional risks?
    Risk of NO treatment?
    Additional risk as consequence of withdrawl?
ProceduresAdditional or different procedures?
Who paysAdditional costs? Who pays?

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