In this example, Subject ABC123-100-1234 received an injection of 5 mL of iohexol prior to a series of blood draws. Each blood sample was centrifuged to extract the plasma. Iohexol concentrations in the plasma samples were plotted against time to determine the glomerular filtration rate (GFR). The measured GFR was then adjusted for body surface area.
The Procedure Agents (AG) domain captures the agents administered to the subject as part of a procedure or assessment as opposed to drugs, medications, and therapies administered with therapeutic intent.
In this example, AG shows a record for an injection of 5 mL of iohexol administered prior to the GFR test.
The measured and adjusted GFR results are represented using the Laboratory Test Results (LB) domain. Note that the LBMETHOD of "CALCULATION" would be documented with more detail in the metadata.
|Row 1:||Shows an example of a GFR derived by the lab, using iohexol concentrations from a series of blood draws taken after the iohexol injection. Data for the blood concentrations are not shown here.|
|Row 2:||Shows an example of a GFR that has been adjusted for body surface area. The result is derived by the lab using the GFR in Row 1.|
|1||ABC123||LB||ABC123-100-1234||1||1234-1||A990406||GFR||Glomerular Filtration Rate||CHEMISTRY||43||mL/min||43||43||mL/min||90||120||LOW||CALCULATION||Y||N||1||SCREENING||-14|
|2||ABC123||LB||ABC123-100-1234||2||1234-1||A990406||GFRBSA||Glomerular Filtration Rate Adj for BSA||CHEMISTRY||35||mL/min/1.73m2||35||35||mL/min/1.73m2||90||120||LOW||CALCULATION||Y||N||1||SCREENING||-14||2015-08-24|
The relationship between the records in AG and in LB is represented using a Related Records (RELREC) dataset. The sponsor used LBSPID as the identifying variable (IDVAR) for the LB side of the relationship, while AGSPID was used to pinpoint the exact iohexol record in AG. A dataset-to-dataset relationship was chosen, since the relationship uses the sponsor-defined variable --SPID. LBSPID and AGSPID were populated in both domains using an identifier unique for each iohexol injection record in AG.