Numeric LB (and LBORRES = BLOQ or and High “<”, “>” PC) values with LBORRES = <1 will result numeric value will leading characters in null value for be present for (˃, <, etc.) or BLQ, LBSTRESN; SUPPLB = purpose of or BLOQ are numeric. calculation. represented differently in SEND datasets and study report. Correlations made Relationships between Relationships in the study report data points may not be between data are not reflected in present only in RELREC points will be RELREC (e.g. data is present collected in 2 different systems) 1. Datapoints labeled Day 1 will be expected Day 0 will be with 0” may reported “Day be present when in SEND dataset “Day 1” is expected Textual differences Uses standard for May or may not use Low/High (controlled Controlled Terminology standard for terminology) Controlled between reports Terminology. If the and SEND data differences are sets. impactful to data interpretation, it is recommended that they be listed out in the nSDRG Modifiers for Modifiers will be listed Modifiers may or pathology data may in --SUPP and/or may not be listed as or may not be listed in addition to part of base finding. in the Study Report depending on May lead to but should be in the how data are collected differences in SEND dataset and base processes are incidence counts. (MA/MI domains) defined. Nomenclature of Will be present as Severity will be listed High severities may differ Controlled Term as defined by between SEND because it is mapped to sponsor. dataset and study Controlled Terminology report (CT).
Numeric LB (and PC) values with leading characters (˃, <, etc.) or BLQ, or BLOQ are represented differently in SEND datasets and study report. LBORRES = BLOQ or LBORRES = <1 will result in null value for LBSTRESN; SUPPLB = numeric. “<”, “>” and numeric value will be present for purpose of calculation. High Correlations made in the study report are not reflected in RELREC (e.g. data is collected in 2 different systems) Relationships between data points may not be present only in RELREC Relationships between data points will be present 1. Datapoints labeled with “Day 0” may be present when in SEND dataset “Day 1” is expected Day 1 will be expected Day 0 will be reported Textual differences (controlled terminology) between reports and SEND data sets. Uses standard for Controlled Terminology May or may not use standard for Controlled Terminology. If the differences are impactful to data interpretation, it is recommended that they be listed out in the nSDRG Low/High Modifiers for pathology data may or may not be listed in the Study Report but should be in the SEND dataset (MA/MI domains) Modifiers will be listed in --SUPP and/or in addition to depending on how data are collected and base processes are defined. Modifiers may or may not be listed as part of base finding. May lead to differences in incidence counts. Nomenclature of severities may differ between SEND dataset and study report Will be present as Controlled Term because it is mapped to Controlled Terminology (CT). Severity will be listed as defined by sponsor. High
10_24_2017_Data_Inconsistency_WP_Review_%283%29_ddo.docx