1. Gregory Steffens Associate Director, Programming Novartis Row – Level Metadata

2. Why Do We Need Row-Level Metadata? | Presentation Title | Presenter Name | Date | Subject | Business Use Only2 If we know why, we will know how to design it and when to use it  A requirement for describing tall-thin data sets in studies and in data standards Storing data in –TESTCD --ORRES kinds of data set requires more than a simple metadata that can describe data sets and variables These data sets have several variables that the simple metadata cannot describe, including ORRES, ORRESU, STRESN, STRESC, STRESU, STRESPOS, etc. In the simpler world these test results and attributes would be stored in short-wide data sets in variables like HEIGHT, HEIGHT_UNIT, WEIGHT, WEIGHT_UNIT, SYSBP, SYSBP_UNIT, SYSBP_POS Storing these test results in ORRES kinds of variables does not mean we need less metadata, a lesser number of variables does not mean a lesser amount of metadata. ORRES contains many virtual variables we need to describe just as if they were in a simple short-wide data set.  A prerequisite for software to transform data for reporting purposes

3. An Example of a Short-Wide Data Set | Presentation Title | Presenter Name | Date | Subject | Business Use Only3 A variable for each result and result unit USUBJIDHEIGHTHEIGHTUWEIGHTWEIGHTUBMIBMIUSEX 174IN190LBS24.39KG/M**2MALE

4. Some of the Metadata to Describe Short-Wide Data | Presentation Title | Presenter Name | Date | Subject | Business Use Only4 A simple description of the attributes of these variables USUBJIDHEIGHTHEIGHTUWEIGHTWEIGHTUBMIBMIUSEX 174IN190LBS24.39KG/M**2MALE TABLECOLUMNCTYPECLENGTHCLABELCFORMATCDERIVATION VSUSUBJIDC15Subject IDUSUBID VSHEIGHTN8Subj Height2.0 VSHEIGHTUC10Height UnitHTU VSWEIGHTN8Subj Weight3.0 VSWEIGHTUC12Weight UnitWTU VSBMIN8Subj BMI5.2BMIFORMULA VSBMIUC7BMI UnitBMIUBMIUNIT VSSEXC6Subj GenderSEX

5. Same Values in a Tall-Thin Data Set | Presentation Title | Presenter Name | Date | Subject | Business Use Only5 Results now all in 1 variable and units in 1 other variable USUBJIDVSTESTCDVSORRESVSORRESUSEX 1HEIGHT74INMALE 1WEIGHT190LBSMALE 1BMI24.39KG/M**2MALE

6. Some Metadata to Describe the Tall-Thin Data Set | Presentation Title | Presenter Name | Date | Subject | Business Use Only6 Row-level metadata must define all the attributes of a variable but for a subset of the rows defined by each unique value of xxTESTCD USUBJIDVSTESTCDVSORRESVSORRESUSEX 1HEIGHT74INMALE 1WEIGHT190LBSMALE 1BMI24.39KG/M**2MALE TABLECOLUMNPARAMPARAMRELCTYPECLENGTHCLABELCFORMATCDERIVATION VSVSTESTCDHEIGHTVSORRESN8Subj Height2.0 VSVSTESTCDHEIGHTVSORRESUC10Height UnitHTU VSVSTESTCDWEIGHTVSORRESN8Subj Weight3.0 VSVSTESTCDWEIGHTVSORRESUC12Weight UnitWTU VSVSTESTCDBMIVSORRESN8Subj BMI5.2BMIFORMULA VSVSTESTCDBMIVSORRESUC7BMI UnitBMIUBMIUNIT

7. USUBJIDVSTESTCDVSORRESVSORRESUSEX 1HEIGHT74INMALE 1WEIGHT190LBSMALE 1BMI24.39KG/M**2MALE VARIABLE TYPEEXAMPLES PRIMARY KEYSUSUBJID, VSTESTCD PARAMETER VARIABLE NAMEVSTESTCD (the last pkey) PARAMETER VARIABLE VALUESHEIGHT, WEIGHT, BMI PARAMETER-RELATEDVSORRES, VSORRESU vsstresn, vsstresc, vsstresu, vspos, vsloc PARAMETER-NONRELATEDSEX | Presentation Title | Presenter Name | Date | Subject | Business Use Only7 Metadata must fully describe all the attributes of all the categories Categories of Variables in Tall-Thin Data Sets

8. What row-level metadata is NOT! | Presentation Title | Presenter Name | Date | Subject | Business Use Only8 Not meant to define other relationships in study metadata  NOT a list of values, ValueList is not simply a list of values  Row-level metadata is not designed to define all the other relationships between study variables  It is designed as metadata, i.e. to describe the ItemDef attributes of virtual variables. That is, to describe the attributes of parameter-related variables for each value of –TESTCD  It should not be used for non-metadata purposes NOT to define the height unit of measure as being inches in the USA but centimeters in the EU NOT to look for males with positive pregnancy test results NOT to define all the edit checks. That can be data driven but NOT by row- level metadata, which is inadequate to this task because it only enables single-domain where conjuncts

9. Problem Solved | Presentation Title | Presenter Name | Date | Subject | Business Use Only9 Metadata and a pair of macros enables easy transformation of data  Transforming data between short-wide and tall-thin data sets is now a very simple macro call  %dt_wide2thin(data=vitals,out=vs,mdlib=md)  %dt_thin2wide(data=vs,out=vitals,mdlib=md)  The tall-thin and short-wide data structures are not perfect for all uses, summary tables, listings, deriving new parameter results from mutiple parameter results, comparing parameter results, etc.  Tall-thin is very better for storage, summary tables  Short-wide is better for listings, deriving, comparing  Define file and data transparency achieved

10. Variable Categories Described | Presentation Title | Presenter Name | Date | Subject | Business Use Only10  Primary Keys Defined in the COLUMNS metadata set  Parameter Name A special primary key that defines the kind of result for the current row Defined in the COLUMNS_PARAM metadata set  Parameter Value  Parameter-related Each non-key variable whose attributes each differ across rows but are the same attributes for the subset of rows defined by parameter variable xxTESTCD. These are “virtual variables”. Defined in the COLUMNS_PARAM metadata set  Parameter-nonrelated Each non-key variable whose attributes do not differ across rows and are not dependent on the parameter variable Defined in the COLUMNS metadata set

11. Columns_param Metadata Set | Presentation Title | Presenter Name | Date | Subject | Business Use Only11  The list of attributes in columns_param are identical to the list in columns. That is to say, everything you need to describe about a short-wide column must be described about the tall-thin parameter-related column.  Storing the study data in tall-thin data sets does not reduce the amount of metadata definition that is required  In data set TABLE, when variable COLUMN equals the value PARAM then the attributes of variable PARAMREL are described in the columns_param metadata set row  There are many other variable attributes than in the example, but these were subsetted to fit in a slide