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Revision History

© 2020 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION) instrument.

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The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC  CDISC disclaims any liability for your use of this material.

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

2 Copyright Status

CDISC believes this instrument is to be in the public domain, but you should perform your own assessment. CDISC has included the BPRS 1988 VERSION in VERSION in the CDISC library of QRS data standards supplements. Hence Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) 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 BPRS 1988 VERSION:

• Overall, JE, Gorham DR: The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacology Bulletin 24:97-99, 1988.

• John E. Overall and Donald R. Gorham, “The Brief Psychiatric Rating Scale,” Psychological Reports, 1962, 10, 799-812, Southern Universities Press, 1962.

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the BPRS 1988 VERSION are listed below.

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1. The scale points include a numeric rating (0-7) and a definition of what is represented by the rating (e.g., 0 = "Not assessed"). For the BPRS 1988 VERSION, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.

2. The BPRS 1988 VERSION instrument includes a total score on the CRF  that is is considered as captured data on the CRF and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the CRF.

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (See SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

   2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

3. Terminology

   1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy. 

3.2 Example for the BPRS 1988 VERSION RS Domain Model

The BPRS 1988 VERSION example VERSION example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the the BPRS 1988 VERSION instrumentVERSION instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RS ORRESRSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.

The table represents the items from the BPRS 1988 VERSION instrument. Rows 20-38 show the subject was not evaluated on this instrument at visit 1. Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

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