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  • A Medications tab is displayed on the Subject Overview page where all of a subject's medications are visible
  • Medications are selected from a list so they do not have to be typed
  • Medications that are available for selection must be added or imported into the central list
  • Medications in the central list must include:
    • Trade Name
    • Generic Name
    • Code (a unique identifier for the medication)
    • Unit of Measure
  • When Medications are entered for a subject they include:
    • Medication Name - selected from the list
    • Begin Date - must be entered in full date format - mm/dd/yyyy
    • End Date - optional but if entered must be in full date format - mm/dd/yyyy
    • Dose - must be entered in the unit of measure specified for the medication in the central list
    • # / Day - must be entered as a whole number although 0 can be used
    • Notes - an optional field
  • Data Sets
    • Medication Groups can be created to define dose equivalenc scales for related medications
    • Medication Groups can be exported in one column of a data set
    • Medication Group Dosage and Medication Grouop Exposure (has ever taken) can be exported for a medication group
    • Medication Dosage and Medication Exposure (has ever taken) can be exported for medications that are assigned to the project
      • Has Ever Taken:  Outputs a 0 (No) or 1 (Yes) if the subject has ever taken the medication
      • Dosage:  Outputs the dosage at an encounter based on the begin/end date of the medication and the date of the encounter
  • Limitations
    • The subject medication fields cannot be modified
    • Only medications assigned to a project can be exported through data sets
      Tip

      Medication Groups can be created from any medications in the central list and then exported

  • Alternate options
    •  Create a Project Variable Group that is a log of all subject medications
      • The variables can be customized
      • All of a subject's medications will be visible on one form
      • When exporting the data each medication will be in a separate column
    • Create an Encounter Variable Group and assign to a non-fixed encounter
      • The variables can be customized
      • Each medication will be a separate non-fixed interval
      • A subject report can list all of a subject's medications on one report
      • When exporting the data each medication will be in a column
      • When it is expected that subjects will have numerous medications this option will result in many non-fixed intervals
Randomization
  • Information View information about the randomization configuration (randomization methods, blinding, stratification)Randomization
    • What randomization method will be used?
    • Who can randomize a subject (there is a separate randomization role)?
    • Who can access / un-blind randomization (there is a separate view randomization assignment role)?
  • What are the practical mechanics involved in randomizing a subject?
  • How will subjects be screened (e.g. inclusion/exclusion criteria, run-in period design)?
  • Be sure there will be enough subjects to reasonably ensure the distribution across strata blocks are filled when using Stratification Factors
    • In pilot studies the limited sample size typically limits the number of strata that can feasibly be used, maybe 1 or 2 variables at most. 
      Info

      The number of strata are multiplicative across variables (e.g., 2 variables with 2 categories each = 4 strata groups)

  • Review if there are known confounding factors that need to be controlled
    • The variables should be controlled in the randomization scheme (e.g., smoking status for a study on lung cancer)
    •  Consider the main dependent measure and whether any of the proposed stratification varaibles are 1) markedly related or 2) would differentially interact with the intervention

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