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Note: CDISC Controlled Terminology is maintained by National Cancer Institute's Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology. 

Reference for the OGI

Guy W, ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare;1976.

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3.2 Example for the OGI QS Domain Model

This OGI example shows the terminology used to implement the instrument in the QS domain. The example shows the data for 1 subject collected at visits 1 and 2 for 3 OGI instruments and uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

The table below illustrates implementation of the OGI instrument dataset qs.xpt. It represents a given subject’s responses to the global questions posed in the 3 OGI instruments at 2 visits. QSSCAT is populated with the specific underlying construct (e.g., “BACK PAIN”) being evaluated. The values of QSORRES, QSSTRESC, and QSSTRESN are determined by the sponsor and are therefore represented here with values of “X”. Note that for a given construct (e.g., “BACK PAIN”), it is neither required nor typical for all 3 OGI instruments to be administered within the same clinical study. All 3 OGI instruments have been included in the example below for illustrative purposes only. QSMETHOD is used to store the type of scale used.

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