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"
    separate from "treatment" procedures.
Patient Subject
Benefits Additional benefit?
Risks Additional risks?
    Risk of
NO treatment?
    Additional risk as consequence of
Procedures Additional or different procedures?
Who pays Additional costs? Who pays?