• Numbers that begin a sentence, title, subtitle, or heading 

• Common fractions 

• Accepted usage such as idiomatic expressions and numbers used as pronouns 

• Other uses of “one” in running text (e.g., when meaning "a")
• Ordinals first through ninth
• Numbers spelled out in quotes or published titles.

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• This 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.
• This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (Use only for instruments this applies to.)

Revision History

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© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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For the first version of a supplement, use the above Revision History table and delete this information box.

When a previously published supplement is being revised, a modified "Revision History" table will need to be used. Add a new column at the right called "Summary of Changes" if this is the first revision to the supplement (see table below). Also add a new row under the column headers with the current information, keeping all rows previously added. The bottom row should be for Version 1.0, with subsequent versions added above each of the previous rows.

If you are making changes to a supplement for the first time, put "Initial Final Version" in the Summary of Changes column for Version 1.0. Then add a row above with the new version number (1.1 if the changes are considered minor such as a typo, 2.0 if they are major such as variable changes) and summary of changes.

Revision History

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© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

Revision History

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Functional Assessment of Cancer Therapy-Hepatobiliary instrument.

CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

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 implement protocols. 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

David Cella, PhD. owns the copyright for the FACT-HEP V4 instrument and has granted CDISC permission to include this supplement

1 Introduction

This document describes the CDISC implementation of the Title instrument.

For CRFs that are NOT created by CDISC, use this statement:  CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

For CRFs that are created by CDISC with SME input, use this statement:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on input from PASI (TA or instrument) subject matter experts. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.)

For CRFs that created by CDISC based on articles, use this statement. Include the 1st sentence for articles that don't have a CRF.  If the 1st sentence is NOT included, then spell out "case report form (CRF)" in the 2nd sentence:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.)

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

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS (spell out "questionnaires, ratings, and scales" if this is a CDISC-created CRF and put QRS in parentheses.) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

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 implement protocols. 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.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

2 Copyright Status

For copyrighted instruments use the following text:  Name of copyright holder (e.g., Board of Regents of The University of Texas System) owns the copyright for the QRS Short_Name instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. (For supplements that are to be distributed by the copyright holder, add: Name of copyright holder (e.g., Board of Regents of The University of Texas System) will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

For public domain instruments use the following text: CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the QRS Short_Name  in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed developed QSTESTCD and QSTEST QSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standardon the actual text on the instrument.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

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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.

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Include the following statements as standalone paragraphs for copyrighted instruments:

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges

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Dr. David Cella and FACIT.org, for the approval to include the

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FACT-HEP V4 in the CDISC data standards.

Reference for the QRS Short_Name FACT-HEP V4:

Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000. 

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This is an example only.  Use the reference from the CDISC definition of the --CAT.

• do not include the parentheses.
• do not include copyright information from the definition about copyright holder and version since that's already included above.
• do add a period to the end. 

If there are multiple references, please use the following format:

References for the QRS Short_Name:

• Copyright 1987, 1997 David Cella, Ph.D.
• These materials discuss and/or include FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved

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• .

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the QRS Short_Name are the FACT-HEP V4 are listed below.

The QRS Short_Name is a multiple-choice instrument 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 IDS-SR 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 QRS Short_Name, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. (replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.

2. Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT 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.: 

   1. If numeric use this wording: The time period of evaluation for theQRS Short_Name is populated in the --EVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the QRS Short_Name is the past 7 days (--EVLINT = "-P7D"). 

   2. If text use this wording: The time period of evaluation for the QRS Short_Name is populated in the --EVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QRS Short_Name is "LIFETIME" (--EVINTX = "LIFETIME").
3. If there are subcategories, include a note that subcategories will be represented in QSSCAT. 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.  For example:  Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

4. Records are created in qs.xpt for every item on the instrument: 

   1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

5. If the instrument standards currently being developed includes logically skipped items, insert:  Some items on the QRS Short_Name may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

   1. RSSTAT = "NOT DONE".       

   2. RSREASND = "LOGICALLY SKIPPED ITEM".
      

   3. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).

6. Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and other scores as needed.  If so, change "that is" to "that are") that 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 [Insert copyright holder's name or other source.].

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the QSDRVFL 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 (QSDRVFL) 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 QSDRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables). Subtotal and total scores are represented in QSORRES.

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

7. This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. instruments will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for instruments is currently under review. Remove this point if it does not apply.

   For Clinical Classifications and Functional Tests (only when collected on the CRF):  *** This section to be updated.  QSEVAL/ID, FTEVAL/ID, and RSEVAL/ID will no longer be used.  Supplemental qualifiers will represent this information. *** For QRS 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 QRS 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.

8. 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 QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

9. Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.
   

10. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN (and other variables such as QSORRESU as needed; only include QSORRES, QSSTRESC, and QSSTRESN if the responses are published in CT with public domains instruments) 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 for the QRS Short_Name QS Domain Model

The QRS Short_Name example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the QRS Short_Name instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. When there are numeric results, then use this sentence next, "This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument."

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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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

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