Concomitant Medications
If Yes, record each medication in a separate set of the following questions of this itemgroup using Trade Names where possible.
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Trade name preferred, e.g. Aspirin
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Unit Dose
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Examples: Abbreviation = Label TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram
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Examples: Abbreviation = Label OD/QD = 1 x Daily BID = 2 x Daily TID = 3 x Daily QID = 4 x Daily PRN = As required
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Examples: Abbreviation = Label IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal
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Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: Current Medical Conditions Non-Serious Adverse Events Serious Adverse Events Form
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Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit. Record Unknown months as UNK
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Start Time
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Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.
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Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.
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Stop Time
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Ongoing Medication
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