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© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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This document describes the CDISC implementation of the OGI instruments, which include the Observer Global Impression of Severity (OGI-S), the Observer Global Impression of Change (OGI-C), and the Observer Global Impression of Improvement (OGI-I). These instruments are commonly administered in clinical trials and clinical practices. 

The OGI instruments were initially developed based on the original Clinical Global Impression (CGI) instrument described in the ECDEU Assessment Manual for Psychopharmacology. As previously noted, both (1) the exact wording used in the global item and (2) the values of both the text and numeric components of the response options historically have been generated by sponsors for each of the 3 OGI instruments as implemented in clinical trials or clinical practices. Therefore, no single, standard case report form (CRF) was developed by CDISC for any of the 3 OGI instruments.

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CDISC specifies how to structure the data that data that has been collected in a database, not what should be collected nor how to conduct clinical assessments or implement

protocols.

Although the United States Food and Drug Administration (FDA) has provided input with regard to this supplement, this input does not constitute FDA endorsement of any particular instrument.

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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, matching the CRF item response text, are represented with preferred terminology in QSORRES.This result is then transformed into the represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

The table represents the items from the OGI instrument.

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