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© 2019 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Title disease response criteria.

CDISC does not modify instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this criteria is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found at the CDISC website at: (https://www.cdisc.org/standards/foundational/sdtmig).

These specific implementation details for this criteria are meant to be used in conjunction with the SDTMIG. All instrument documentation can be found on the CDISC web site at: (https://www.cdisc.org/foundational/qrs). Is this correct???  

The CDISC Intellectual Property Policy can be found on the CDISC web site 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.

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.  (Include this line only for supplements that the US FDA will be reviewing.)

2 Copyright Status

RECIST 1.1 disease response criteria are in the public domain. CDISC has included the RECIST 1.1 criteria as part of CDISC Data Standards. Hence, CDISC developed data standards for each item based on the actual criteria. There may be many versions of this criteria in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology and (2) standard database structure with examples.

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 (https://www.cdisc.org/standards/semantics/terminology).

Reference:

E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij. New response evaluation criteria in solid tumours; Revised RECIST guideline (version 1.1). European Journal of Cancer 2009; 45:228-247 (This is an example only. Use the CDISC definition included in the --CAT.)

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 QRS Short_Name are listed below.

The QRS Short_Name is a multiple-choice criteria that clinicians may use to assess the severity of depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.

1. Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the RESIST 1.1 did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the Criteria Short_Name, 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. Include a description of the evaluation interval if one exists. This may be numeric (RSEVLINT) or text (RSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use RSEVINTX instead of "RSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes. The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: The time period of evaluation for the QRS Short_Name is populated in the RSEVLINT field in ISO 8601 format (or RSEVINTX, as appropriate) when the evaluation interval can be precisely described as duration. The evaluation interval for the QRS Short_Name is the past 7 days.

3. If there are subcategories, include a note that subcategories will be represented in RSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply.

4. Include this point if score(s) are submitted to SDTM. Use the following language as stated if this point applies to the new criteria. Remove this point if it does not apply.: The Criteria Short_Name includes a total score that is considered as captured data on the CRF and is not considered as derived in the example below.

   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 sub-totals and total scores. An investigator derived score written on a CRF 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: 4.1.1.8.1, Origin Metadata for Variables].

5. Evaluator information is only to be included when the information is collected directly on the CRF. Questionnaires will no longer be using RSEVAL/RSEVALID; however RSEVAL/RSEVALID will continue to be used on criterias of disease response. Remove this point if it does not apply.

   The evaluator is stored in RSEVAL (FTEVAL). For Criteria Short_Name, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For Criteria Short_Name, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC controlled terminology is available for Evaluator (e.g., --EVAL="HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID="RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.

6. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the Criteria Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

7. Terminology

   1. RSCAT, RSTESTCD and RSTEST (and other variables such as RSORRESU as needed) values are included in CDISC controlled terminology.

   2. A full list of value sets for the qualifier, timing, result, and unit fields is provided in Section 4: SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

3.2 Example 1

Insert overall description of the example.

3.2.1 RS Domain Model

The example below shows the terminology used to implement the Criteria Short_Name in the RS domain. This example shows the data for one subject collected at the baseline visit for a Criteria Short_Name instrument. The example uses CDISC controlled terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. 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 Criteria Short_Name form.

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.

RSTESTCD = "IDSR101" RSTEST = "IDSR1-Falling Asleep"

RSTESTCD = "IDSRSx" RSTEST = "IDSR1-RSRS"

RSTESTCD = "IDSR109B" RSTEST = "IDSR1-Mood Attributed to Environment"

RSTESTCD = "IDSR130" RSTEST = "IDSR1-Leaden Paralysis/Physical Energy"

5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for the RS domain (supprs) special purpose dataset.

End of Document