Submission-Level Information A total of 6 data elements, shown in Table 1, pertain to the entire submission. Most relate to regulatory status. Table 1: Submission-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 Index Name Label Terms or Value (S=SDTM, A=ADaM) Format 5 IND IND Number Num 6 digit Investigational New Drug (IND) 010010 No existing Controlled Terminology for S/TS new identifier application number. If study not TSPARM/TSPARMCD. TSPARM/TSPARMCD performed under IND, leave blank. 7 NDA NDA Number Num 6 digit FDA new drug application (NDA) 021212 No existing Controlled Terminology for S/TS new identifier number, if available/applicable. If TSPARM/TSPARMCD. TSPARM/TSPARMCD not applicable, leave blank. 8 BLA BLA Number Num 6 digit FDA identification number for 123456 No existing Controlled Terminology for S/TS new identifier biologics license application, if TSPARM/TSPARMCD. TSPARM/TSPARMCD available/applicable. If not applicable, leave blank. 3 SPONCNT Sponsor Num Integer Total count of sponsors 1 No existing Controlled Terminology for S/TS new Count throughout the study. If there was TSPARM/TSPARMCD. TSPARM/TSPARMCD a change in the sponsor while the study was ongoing, with sponsors as defined in 21 CFR 312.3, enter an integer indicating the total count of sponsors. If there was no change in the sponsor while the study was ongoing, enter “1”.
Submission-Level Information A total of 6 data elements, shown in Table 1, pertain to the entire submission. Most relate to regulatory status. Table 1: Submission-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) 5 IND IND Number Num 6 digit identifier Investigational New Drug (IND) application number. If study not performed under IND, leave blank. 010010 No existing Controlled Terminology for TSPARM/TSPARMCD. S/TS new TSPARM/TSPARMCD 7 NDA NDA Number Num 6 digit identifier FDA new drug application (NDA) number, if available/applicable. If not applicable, leave blank. 021212 No existing Controlled Terminology for TSPARM/TSPARMCD. S/TS new TSPARM/TSPARMCD 8 BLA BLA Number Num 6 digit identifier FDA identification number for biologics license application, if available/applicable. If not applicable, leave blank. 123456 No existing Controlled Terminology for TSPARM/TSPARMCD. S/TS new TSPARM/TSPARMCD 3 SPONCNT Sponsor Count Num Integer Total count of sponsors throughout the study. If there was a change in the sponsor while the study was ongoing, with sponsors as defined in 21 CFR 312.3, enter an integer indicating the total count of sponsors. If there was no change in the sponsor while the study was ongoing, enter “1”. 1 No existing Controlled Terminology for TSPARM/TSPARMCD. S/TS new TSPARM/TSPARMCD
PhUSE_InspectionSiteSelectionDataElements_Reqs_CDISC_Gap_Analysis_2016-05-26.docx