Versions Compared

Old Version 15

changes.mady.by.user Unknown User (bvickers)

Saved on

compared with

New Version 16

changes.mady.by.user swarupa sudini

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Page properties
Title

Observer Global Impression (OGI)

CDISC Reference

Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

OGI

QRS Permission StatusPublic Domain
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2023-08-2325
Notes to ReadersThis supplement is intended to be used with other CDISC User Guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

...

Revision History

DateVersion
2023-08-23251.0

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

...

CDISC specifies how to structure the 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.

...

QSTESTCD = OGI0101   QSTEST = OGI01-Severity   QSMETHOD = LIKERT SCALE 7-POINT

QSORRES

QSSTRESC

QSSTRESN

Normal

1

1

Borderline

2

2

Mild

3

3

Moderate

4

4

Marked

5

5

Severe

6

6

Extreme

7

7


QSTESTCD  QSTESTCD =  OGI0101   QSTEST = OGI01-Severity   QSMETHOD = LIKERT SCALE 4-POINT

...