SAE (Non-Serious AEs) PROTVIOL (Protocol Violations) DEATH (Deaths) For the other 18 data elements (46%) shown below, such as investigator contact information, most are included in the eCTD submission but are not in a format amenable to data analysis. Although technology exists to mine the xml backbone of the eCTD for information, it is not clear that this would be a more efficient process than obtaining it by more traditional methods. Issues are that some of the information may not be known at the time CRT datasets are finalized (e.g., NDA or BLA number), while other information may be known (e.g., investigator contact information), potentially resulting in some xml backbone mining being done by the FDA and some by the sponsor. UNDERIND (Under IND) PHONE (Phone) TRTEFFR (Treatment Efficacy Result) FAX (FAX) TRTEFFS (Treatment Efficacy Std Dev) EMAIL (Email Address) SITEEFFE (Site Efficacy Effect Size) COUNTRY (Country) SITEEFFS (Site Efficacy Effect Size Std STATE (State) Dev) CITY (City) FINLDISC (Financial Disclosure Amt.) POSTAL (Postal Code) LASTNAME (Last Name) STREET (Street Address) FIRSTNAME (First Name) STREET1 (Street Address Cont’d) MINITIAL (Middle Initial) A tabular representation of this information is shown below: CDISC Applicability of Data Elements Variable Category Variable Count Fraction of Total (39) Explicitly accommodated by CDISC 7 18% Accommodated by CDISC if extensible Controlled 5 13% Terminology used Can easily derive from SDTM/ADaM and capture in 9 23% ADaM No existing path 18 46%
SAE (Non-Serious AEs) DEATH (Deaths) PROTVIOL (Protocol Violations) For the other 18 data elements (46%) shown below, such as investigator contact information, most are included in the eCTD submission but are not in a format amenable to data analysis. Although technology exists to mine the xml backbone of the eCTD for information, it is not clear that this would be a more efficient process than obtaining it by more traditional methods. Issues are that some of the information may not be known at the time CRT datasets are finalized (e.g., NDA or BLA number), while other information may be known (e.g., investigator contact information), potentially resulting in some xml backbone mining being done by the FDA and some by the sponsor. UNDERIND (Under IND) TRTEFFR (Treatment Efficacy Result) TRTEFFS (Treatment Efficacy Std Dev) SITEEFFE (Site Efficacy Effect Size) SITEEFFS (Site Efficacy Effect Size Std Dev) FINLDISC (Financial Disclosure Amt.) LASTNAME (Last Name) FIRSTNAME (First Name) MINITIAL (Middle Initial) PHONE (Phone) FAX (FAX) EMAIL (Email Address) COUNTRY (Country) STATE (State) CITY (City) POSTAL (Postal Code) STREET (Street Address) STREET1 (Street Address Cont’d) A tabular representation of this information is shown below: CDISC Applicability of Data Elements Variable Category Variable Count Fraction of Total (39) Explicitly accommodated by CDISC 7 18% Accommodated by CDISC if extensible Controlled Terminology used 5 13% Can easily derive from SDTM/ADaM and capture in ADaM 9 23% No existing path 18 46%
PhUSE_InspectionSiteSelectionDataElements_Reqs_CDISC_Gap_Analysis_2016-05-26.docx