4 SPONNAME Sponsor Char String Full name of the sponsor Drug Co, S/TSPARM where Name organization conducting the study Inc. TSPARMCD=’SPONSOR’ at the time of study completion, as defined in 21CFR 312.3(a). If the sponsor name exceeds 200 characters, provide the abbreviated sponsor name from Clinicaltrials.gov and document this in the Notes or Description section in the define file (Clinical Site Data Elements Summary). 9 SUPPNUM Supplemental Num Integer Serial number for supplemental 4 No existing Controlled Terminology for S/TS new Number application, if applicable. If no TSPARM/TSPARMCD. TSPARM/TSPARMCD information is available, leave blank.
4 SPONNAME Sponsor Name Char String Full name of the sponsor organization conducting the study at the time of study completion, as defined in 21CFR 312.3(a). If the sponsor name exceeds 200 characters, provide the abbreviated sponsor name from Clinicaltrials.gov and document this in the Notes or Description section in the define file (Clinical Site Data Elements Summary). Drug Co, Inc. S/TSPARM where TSPARMCD=’SPONSOR’ 9 SUPPNUM Supplemental Number Num Integer Serial number for supplemental application, if applicable. If no information is available, leave blank. 4 No existing Controlled Terminology for TSPARM/TSPARMCD. S/TS new TSPARM/TSPARMCD
PhUSE_InspectionSiteSelectionDataElements_Reqs_CDISC_Gap_Analysis_2016-05-26.docx