Study-Level Information A total of 5 data elements, shown in Table 2, pertain to the study. Variable STUDYID is a potential index variable and key that allows for integration with other datasets. Table 2: Study-Level Information [NOTE: Yellow highlight indicates a proposed change (new variable, variable name, variable label) from the draft 7 November 2012 structure] Variable Variable Variable Type Controlled Notes or Description Sample Comments CDISC Source (S=SDTM, Index Name Label Terms or Value A=ADaM) Format 1 STUDYID Study Char String Study or trial identification ABC-123 S/TS.STUDYID Identifier number. 2 STUDYTL Study Title Char String Title of the study as listed in the Double S/TS.TSPARMCD=’TITLE’ clinical study report (limit 200 blind, characters). If the title exceeds randomized, 200 characters, provide placebo the abbreviated title from controlled clinical Clinicaltrials.gov and document study on the this in the Notes or Description influence of section in the define file (Clinical drug X on Site Data Elements Summary). indication Y 11 ARM Description Char String Plain text label for the name Active name S/TA.ARM of Planned given to an Arm or treatment and dose Treatment group as referenced in the (e.g., Active Arm clinical study report (limit 200 25mg), characters). Comparator product name (e.g., Drug x), or Placebo
Study-Level Information A total of 5 data elements, shown in Table 2, pertain to the study. Variable STUDYID is a potential index variable and key that allows for integration with other datasets. Table 2: Study-Level Information [NOTE: Yellow highlight indicates a proposed change (new variable, variable name, variable label) from the draft 7 November 2012 structure] Variable Index Variable Name Variable Label Type Controlled Terms or Format Notes or Description Sample Value Comments CDISC Source (S=SDTM, A=ADaM) 1 STUDYID Study Identifier Char String Study or trial identification number. ABC-123 S/TS.STUDYID 2 STUDYTL Study Title Char String Title of the study as listed in the clinical study report (limit 200 characters). If the title exceeds 200 characters, provide the abbreviated title from Clinicaltrials.gov and document this in the Notes or Description section in the define file (Clinical Site Data Elements Summary). Double blind, randomized, placebo controlled clinical study on the influence of drug X on indication Y S/TS.TSPARMCD=’TITLE’ 11 ARM Description of Planned Treatment Arm Char String Plain text label for the name given to an Arm or treatment group as referenced in the clinical study report (limit 200 characters). Active name and dose (e.g., Active 25mg), Comparator product name (e.g., Drug x), or Placebo S/TA.ARM
PhUSE_InspectionSiteSelectionDataElements_Reqs_CDISC_Gap_Analysis_2016-05-26.docx