Appendix 2: Proposed Revised FDA Draft Technical Specifications Controlled Variable Variable Variable Label Type Terms or Notes or Description Sample Value Index Name Format 1 STUDYID Study Identifier Char String Study or trial identification number. ABC-123 2 STUDYTL Study Title Char String Title of the study as listed in the clinical study report (limit 200 characters). If the title Double blind, exceeds 200 characters, provide the abbreviated title from Clinicaltrials.gov and randomized placebo controlled clinical document this in the Notes or Description section in the define file (Clinical Site Data study on the Elements Summary). influence of drug X on indication Y 3 SPONCNT Sponsor Count Num Integer Total count of sponsors throughout the study. If there was a change in the sponsor while 1 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”. 4 SPONNAME Sponsor Name Char String Full name of the sponsor organization conducting the study at the time of study Drug Co, Inc. completion, as defined in 21 CFR 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). 5 IND IND Number Num 6 digit Investigational New Drug (IND) application number. If study not performed under IND, 010010 identifier leave blank. 6 UNDERIND Under IND Char String Value should equal if study at the site was conducted under an IND (i.e., a Form FDA Y “Y” 1572 was signed by the investigator) and if the study was not conducted under an “N” IND at the site (i.e., a Form FDA 1572 was not signed by the investigator). 7 NDA NDA Number Num 6 digit FDA new drug application (NDA) number, if available/applicable. If not applicable, leave 021212 identifier blank. 8 BLA BLA Number Num 6 digit FDA identification number for biologics license application, if available/applicable. If not 123456 identifier applicable, leave blank.
Appendix 2: Proposed Revised FDA Draft Technical Specifications Variable Index Variable Name Variable Label Type Controlled Terms or Format Notes or Description Sample Value 1 STUDYID Study Identifier Char String Study or trial identification number. ABC-123 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 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 4 SPONNAME Sponsor Name Char String Full name of the sponsor organization conducting the study at the time of study completion, as defined in 21 CFR 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. 5 IND IND Number Num 6 digit identifier Investigational New Drug (IND) application number. If study not performed under IND, leave blank. 010010 6 UNDERIND Under IND Char String Value should equal “Y” if study at the site was conducted under an IND (i.e., a Form FDA 1572 was signed by the investigator) and “N” if the study was not conducted under an IND at the site (i.e., a Form FDA 1572 was not signed by the investigator). Y 7 NDA NDA Number Num 6 digit identifier FDA new drug application (NDA) number, if available/applicable. If not applicable, leave blank. 021212 8 BLA BLA Number Num 6 digit identifier FDA identification number for biologics license application, if available/applicable. If not applicable, leave blank. 123456
PhUSE_InspectionSiteSelectionDataElements_Reqs_CDISC_Gap_Analysis_2016-05-26.docx