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Title | Functional Assessment of Cancer Therapy-Hepatobiliary General Version 4 (FACT-HEP G V4) |
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CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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QRS Short Name | |
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QRS Permission Status | ApproveApproved |
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Team | Pancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Supplement Version | 1.0 |
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Status | DRAFT |
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Date | 20022023-1107-1628 |
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Notes | - 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.
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Revision History
Date | Version |
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20222023-1107-1628 | 1.0 Draft |
© 2022 Clinical 2023 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-General Version 4 (FACT-G V4) Jira |
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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.
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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.
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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 G V4 instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on 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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title | Information for Reviewers |
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The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF. |
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.
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 Dr. David Cella and FACIT.org, for the approval to include the FACT-HEP V4 in the CDISC data standards.
Reference for the FACT-HEP V4:
- 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.
3 The QS Domain Model
3.1 Assumptions for the QS Domain Model
These materials discuss and/or include the 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. Copyright 1987, 1997 David Cella, PhD.
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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title | Information for Reviewers |
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The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF. |
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.
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 Dr. David Cella and FACIT.org, for the approval to include the FACT-G V4 in the CDISC data standards.
Reference for the FACT-G V4:
- FACIT.org for more information as well as the scoring guide.
3 The QS Domain Model
3.1 Assumptions for the QS Domain Model
All assumptions and business rules described in the SDTMIG QS All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the FACT-HEP G V4 are listed below.
The FACT-HEP G V4 is a multiple-choice health-related general quality of life questionnaire about problems associated with hepatobiliary cancer. It consists of 45 27 items rated on a 5-point scale.
All items rated on a 5-point scale include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "Not at all", 4 = "Very much"). For the FACT-HEP G V4, QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
FAC01514 FAC00114 may be rated on a 5-point scale or the subject may prefer not to answer. When the checkbox is marked that the subject prefers not to rate answer the item, this is noted with QSSTAT = "NOT DONE" and QSREASND = "PREFER NOT TO ANSWER". QSORRES, QSSTRESC, and QSSTRESN are all missing.
The time period of evaluation for the FACT-HEP G V4 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the FACT-HEP G V4 is the past 7 days (QSEVLINT = "-P7D").
Items are divided into 5 subcategories represented 4 subcategories Jira |
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represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", and "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".
Records are created in qs.xpt for every item on the instrument:
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 = "LOGICALLY SKIPPED ITEM" or QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.
The FACT-HEP G V4 instrument includes subscale scores for each subcategory in addition to trial outcome index, FACT-G, and total scores a total score per FACIT.org's scoring materials and are considered as captured data on the CRF and are 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 FACIT.org.
Subscores and total scores are represented in QSORRES.
- If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
- Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the QRS FACT-HEP V4 QS Domain Model
The FACT-HEP V4 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 FACT-HEP V4 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. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.
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We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below. |
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- that they are submitted to SDTM and verified in ADaM whenever feasible.
- Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the QRS FACT-G V4 QS Domain Model
The FACT-G V4 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 FACT-G V4 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. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.
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We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below. |
The following table
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represents the items from the FACT-G V4 instrument. The subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, and no date is assumed for when the visit would have occurred. Dataset wrap |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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Dataset wrap |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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1 | STUDYX | QS | 2324-P0001 | 1 | FAC01501 | FAC015-I Have a Lack of Energy | FACT-HEP V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 2 | STUDYX | QS | 2324-P0001 | 2 | FAC01502 | FAC015-I Have Nausea | FACT-HEP V4 | PHYSICAL WELL-BEING | Not at all | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | 3 | STUDYX | QS | 2324-P0001 | 3 | FAC01503 | FAC015-Trouble Meeting Needs of Family | FACT-HEP V4 | PHYSICAL WELL-BEING | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | 4 | STUDYX | QS | 2324-P0001 | 4 | FAC01504 | FAC015-I Have Pain | FACT-HEP V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 5 | STUDYX | QS | 2324-P0001 | 5 | FAC01505 | FAC015-Botheredby Treatment Side Effect | FACT-HEP V4 | PHYSICAL WELL-BEING | Not at all | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | 6 | STUDYX | QS | 2324-P0001 | 6 | FAC01506 | FAC015-I Feel Ill | FACT-HEP V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 7 | STUDYX | QS | 2324-P0001 | 7 | FAC01507 | FAC015-I Am Forced to Spend Time in Bed | FACT-HEP V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 8 | STUDYX | QS | 2324-P0001 | 8 | FAC01508 | FAC015-I Feel Close to My Friends | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 9 | STUDYX | QS | 2324-P0001 | 9 | FAC01509 | FAC015-Get Emotional Support From Family | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015-I Get Support From Friends | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | 11 | STUDYX | QS | 2324-P0001 | 11 | FAC01511 | FAC015-My Family Has Accepted My Illness | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 12 | STUDYX | QS | 2324-P0001 | 12 | FAC01512 | FAC015-Satisfied Communication Illness | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 4 | Y | 1 | 2015-05-15 | -P7D | 13 | STUDYX | QS | 2324-P0001 | 13 | FAC01513 | FAC015-I Feel close to My Partner | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 4 | Y | 1 | 2015-05-15 | -P7D | 14 | STUDYX | QS | 2324-P0001 | 14 | FAC01514 | FAC015-I Am Satisfied With My Sex Life | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | NOT DONE | PREFER NOT TO ANSWER | Y | 1 | 2015-05-15 | -P7D | 15 | STUDYX | QS | 2324-P0001 | 15 | FAC01515 | FAC015-I Feel Sad | FACT-HEP V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 16 | STUDYX | QS | 2324-P0001 | 16 | FAC01516 | FAC015-Satisfied With How I Am Coping | FACT-HEP V4 | EMOTIONAL WELL-BEING | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 17 | STUDYX | QS | 2324-P0001 | 17 | FAC01517 | FAC015-Losing Hope Against Illness | FACT-HEP V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 18 | STUDYX | QS | 2324-P0001 | 18 | FAC01518 | FAC015-I Feel Nervous | FACT-HEP V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 19 | STUDYX | QS | 2324-P0001 | 19 | FAC01519 | FAC015-I Worry About Dying | FACT-HEP V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 20 | STUDYX | QS | 2324-P0001 | 20 | FAC01520 | FAC015-Worry My Condition Will Get Worse | FACT-HEP V4 | EMOTIONAL WELL-BEING | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | 21 | STUDYX | QS | 2324-P0001 | 21 | FAC01521 | FAC015-I Am Able to Work | FACT-HEP V4 | FUNCTIONAL WELL-BEING | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 22 | STUDYX | QS | 2324-P0001 | 22 | FAC01522 | FAC015-My Work Is Fulfilling | FACT-HEP V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 23 | STUDYX | QS | 2324-P0001 | 23 | FAC01523 | FAC015-I Am Able to Enjoy Life | FACT-HEP V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 24 | STUDYX | QS | 2324-P0001 | 24 | FAC01524 | FAC015-I Have Accepted My Illness | FACT-HEP V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | 25 | STUDYX | QS | 2324-P0001 | 25 | FAC01525 | FAC015-I Am Sleeping Well | FACT-HEP V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | 26 | STUDYX | QS | 2324-P0001 | 26 | FAC01526 | FAC015-Enjoy Things I Usually Do for Fun | FACT-HEP V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | 27 | STUDYX | QS | 2324-P0001 | 27 | FAC01527 | FAC015-Content With Quality of My Life | FACT-HEP V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 28 | STUDYX | QS | 2324-P0001 | 28 | FAC01528 | FAC015-Swelling/Cramps in Stomach Area | FACT-HEP V4 | ADDITIONAL CONCERNS | Somewhat | 2 | 2 | Y | 1 | 2015-05-15 | -P7D | 29 | STUDYX | QS | 2324-P0001 | 29 | FAC01529 | FAC015-I Am Losing Weight | FACT-HEP V4 | ADDITIONAL CONCERNS | Not at all | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | 30 | STUDYX | QS | 2324-P0001 | 30 | FAC01530 | FAC015-I Have Control of My Bowels | FACT-HEP V4 | ADDITIONAL CONCERNS | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 31 | STUDYX | QS | 2324-P0001 | 31 | FAC01531 | FAC015-I Can Digest My Food Well | FACT-HEP V4 | ADDITIONAL CONCERNS | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 32 | STUDYX | QS | 2324-P0001 | 32 | FAC01532 | FAC015-I Have Diarrhea | FACT-HEP V4 | ADDITIONAL CONCERNS | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -P7D | 33 | STUDYX | QS | 2324-P0001 | 33 | FAC01533 | FAC015-I Have a Good Appetite | FACT-HEP V4 | ADDITIONAL CONCERNS | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -P7D | 34 | STUDYX | QS | 2324-P0001 | 34 | FAC01534 | FAC015-Unhappy About Change in My Appear | FACT-HEP V4 | ADDITIONAL CONCERNS | Not at all | 0 | 0 | Y | 1 | 2015-05-15 | -P7D | 35 | STUDYX | QS | 2324-P0001 | 351 | FAC01535FAC00101 | FAC015FAC001-I Have Pain in My Backa Lack of Energy | FACT-HEP G V4 | ADDITIONAL CONCERNSPHYSICAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 362 | STUDYX | QS | 2324-P0001 | 362 | FAC01536FAC00102 | FAC015FAC001-I Am Bothered by ConstipationHave Nausea | FACT-HEP G V4 | ADDITIONAL CONCERNS | A little bit | 1 | PHYSICAL WELL-BEING | Not at all | 0 | 01 |
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| Y | 1 | 2015-05-15 | -P7D | 373 | STUDYX | QS | 2324-P0001 | 373 | FAC01537FAC00103 | FAC015-I Feel FatiguedFAC001-Trouble Meeting Needs of Family | FACT-HEP G V4 | ADDITIONAL CONCERNSPHYSICAL WELL-BEING | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | 384 | STUDYX | QS | 2324-P0001 | 384 | FAC01538FAC00104 | FAC015-Able to Do My Usual ActivitiesFAC001-I Have Pain | FACT-HEP G V4 | ADDITIONAL CONCERNS | PHYSICAL WELL-BEING | A A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 395 | STUDYX | QS | 2324-P0001 | 395 | FAC01539FAC00105 | FAC015-Bothered by Jaundice/Yellow SkinFAC001-Botheredby Treatment Side Effect | FACT-HEP G V4 | ADDITIONAL CONCERNS | A little bit | 1 | PHYSICAL WELL-BEING | Not at all | 0 | 01 |
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| Y | 1 | 2015-05-15 | -P7D | 406 | STUDYX | QS | 2324-P0001 | 406 | FAC01540FAC00106 | FAC015FAC001-I Have Had FeversFeel Ill | FACT-HEP G V4 | ADDITIONAL CONCERNS | Not at all | 0 | PHYSICAL WELL-BEING | A little bit | 1 | 10 |
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| Y | 1 | 2015-05-15 | -P7D | 417 | STUDYX | QS | 2324-P0001 | 417 | FAC01541FAC00107 | FAC015FAC001-I Have Had ItchingAm Forced to Spend Time in Bed | FACT-HEP G V4 | ADDITIONAL CONCERNSPHYSICAL WELL-BEING | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 428 | STUDYX | QS | 2324-P0001 | 428 | FAC01542FAC00108FAC015 | -Had Change in the Way Food TastesFAC001-I Feel Close to My Friends | FACT-HEP G V4 | ADDITIONAL CONCERNS | Not at all | 0 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 30 |
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| Y | 1 | 2015-05-15 | -P7D | 439 | STUDYX | QS | 2324-P0001 | 439 | FAC01543FAC00109 | FAC015-I Have Had ChillsFAC001-Get Emotional Support From Family | FACT-HEP G V4 | ADDITIONAL CONCERNS | Not at all | 0 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 30 |
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| Y | 1 | 2015-05-15 | -P7D | 4410 | STUDYX | QS | 2324-P0001 | 4410 | FAC01544FAC00110 | FAC015-My Mouth Is DryFAC001-I Get Support From Friends | FACT-HEP G V4 | ADDITIONAL CONCERNS | A little bit | 1 | SOCIAL/FAMILY WELL-BEING | Somewhat | 2 | 21 |
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| Y | 1 | 2015-05-15 | -P7D | 4511 | STUDYX | QS | 2324-P0001 | 4511 | FAC01545FAC00111FAC015 | -Discomfort/Pain in Stomach AreaFAC001-My Family Has Accepted My Illness | FACT-HEP G V4 | ADDITIONAL CONCERNS | Somewhat | 2 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 32 |
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| Y | 1 | 2015-05-15 | -P7D | 4612 | STUDYX | QS | 2324-P0001 | 4612 | FAC01546FAC00112 | FAC015-Physical Subscale ScoreFAC001-Satisfied Communication Illness | FACT-HEP G V4 | 22 | 22 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 422 |
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| Y | 1 | 2015-05-15 | -P7D | 4713 | STUDYX | QS | 2324-P0001 | 4713 | FAC01547FAC00113FAC015 | -Social/Family Subscale ScoreFAC001-I Feel close to My Partner | FACT-HEP V4 | 22 | 22 | G V4 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 422 |
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| Y | 1 | 2015-05-15 | -P7D | 4814 | STUDYX | QS | 2324-P0001 | 4814 | FAC01548FAC00114 | FAC015-Emotional Subscale ScoreFAC001-I Am Satisfied With My Sex Life | FACT-HEP G V4 | 17 | 17 | SOCIAL/FAMILY WELL-BEING |
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| NOT DONE | PREFER NOT TO ANSWER17 | Y | 1 | 2015-05-15 | -P7D | 49 | STUDYX | QS | 2324-P0001 | 49 | FAC01549 | FAC015-Functional Subscale Score | FACT-HEP V4 | 16 | 16 | 16 | Y | Jira |
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| 1 | 2015-05-15 | -P7D | 5015 | STUDYX | QS | 2324-P0001 | 5015 | FAC01550FAC00115 | FAC015-Additional Concern Subscale ScoreFAC001-I Feel Sad | FACT-HEP G V4 | 54 | 54 | EMOTIONAL WELL-BEING | A little bit | 1 | 154 |
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| Y | 1 | 2015-05-15 | -P7D | 5116 | STUDYX | QS | 2324-P0001 | 5116 | FAC01551FAC00116 | FAC015-Trial Outcome Index ScoreFAC001-Satisfied With How I Am Coping | FACT-HEP G V4 | 92 | 92 | | EMOTIONAL WELL-BEING | Quite a bit | 3 | 392 |
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| Y | 1 | 2015-05-15 | -P7D | 5217 | STUDYX | QS | 2324-P0001 | 5217 | FAC01552FAC00117 | FAC015FAC001-Losing Hope Against Illness | FACT-G Total ScoreV4FACT | EMOTIONAL WELL-HEP V4 | 77 | 77 | BEING | A little bit | 1 | 177 |
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| Y | 1 | 2015-05-15 | -P7D | 5318 | STUDYX | QS | 2324-P0001 | 5318 | FAC01553FAC00118 | FAC015-Total ScoreFAC001-I Feel Nervous | FACT-HEP G V4 | 131 | 131 | EMOTIONAL WELL-BEING | A little bit | 1 | 1131 |
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| Y | 1 | 2015-05-15 | -P7D | 5419 | STUDYX | QS | 2324-P0001 | 119 | FAC01501FAC00119 | FAC015FAC001-I Have a Lack of EnergyWorry About Dying | FACT-HEP G V4 | PHYSICAL EMOTIONAL WELL-BEING | NOT DONE | 2 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 2055 | STUDYX | QS | 2324-P0001 | 220 | FAC01502FAC00120 | FAC015-I Have NauseaFAC001-Worry My Condition Will Get Worse | FACT-HEP G V4 | PHYSICAL EMOTIONAL WELL-BEING | NOT DONESomewhat | 2 | 562 |
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| STUDYXY | QS1 | 2324-P0001 | 3 | FAC01503 | FAC015-Trouble Meeting Needs of Family | FACT-HEP V4 | PHYSICAL WELL-BEING | NOT DONE | 2 | 2015-05-15 | -P7D | 21 | 57 | STUDYX | QS | 2324-P0001 | 421 | FAC01504FAC00121 | FAC015FAC001-I Have PainAm Able to Work | FACT-HEP G V4 | PHYSICAL FUNCTIONAL WELL-BEING | NOT DONE | 2 | 58 | STUDYX | QS | 2324-P0001 | 5 | FAC01505 | FAC015-Botheredby Treatment Side Effect | FACT-HEP V4 | PHYSICAL WELL-BEING | NOT DONE | 2 | 59 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 22 | STUDYX | QS | 2324-P0001 | 622 | FAC01506FAC00122 | FAC015-I Feel IllFAC001-My Work Is Fulfilling | FACT-HEP G V4 | PHYSICAL FUNCTIONAL WELL-BEING | NOT DONE | 2 | | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | 2360 | STUDYX | QS | 2324-P0001 | 723 | FAC01507FAC00123 | FAC015FAC001-I Am Forced to Spend Time in BedAble to Enjoy Life | FACT-HEP V4 | PHYSICAL WELL-BEING | NOT DONE | 2 | G V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | 24 | 61 | STUDYX | QS | 2324-P0001 | 824 | FAC01508FAC00124 | FAC015FAC001-I Feel Close to My FriendsHave Accepted My Illness | FACT-HEP G V4 | SOCIAL/FAMILY FUNCTIONAL WELL-BEING | NOT DONESomewhat | 2 | 622 |
|
| STUDYXY | QS1 | 2324-P0001 | 9 | FAC01509 | FAC015-Get Emotional Support From Family | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | NOT DONE | 2 | 2015-05-15 | -P7D | 2563 | STUDYX | QS | 2324-P0001 | 1025 | FAC01510FAC00125 | FAC015FAC001-I Get Support From FriendsAm Sleeping Well | FACT-HEP G V4 | SOCIAL/FAMILY FUNCTIONAL WELL-BEING | NOT DONESomewhat | 2 | 642 |
|
| STUDYXY | QS1 | 2324-P0001 | 11 | FAC01511 | FAC015-My Family Has Accepted My Illness | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | NOT DONE | 2 | 65 | 2015-05-15 | -P7D | 26 | STUDYX | QS | 2324-P0001 | 1226 | FAC01512FAC00126 | FAC015-Satisfied Communication IllnessFAC001-Enjoy Things I Usually Do for Fun | FACT-HEP G V4 | SOCIAL/FAMILY FUNCTIONAL WELL-BEING | Somewhat | 2NOT DONE | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 2766 | STUDYX | QS | 2324-P0001 | 1327 | FAC01513FAC00127 | FAC015-I Feel close to My PartnerFAC001-Content With Quality of My Life | FACT-HEP G V4 | SOCIAL/FAMILY FUNCTIONAL WELL-BEING | NOT DONE | 2 | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | 2867 | STUDYX | QS | 2324-P0001 | 1428 | FAC01514FAC00128 | FAC015-I Am Satisfied With My Sex LifeFAC001-Physical Subscale Score | FACT-HEP V4 | SOCIAL/FAMILY WELL-BEING | NOT DONE | 2 | 68 | G V4 |
| 22 | 22 | 22 |
|
| Y | 1 | 2015-05-15 | -P7D | 29 | STUDYX | QS | 2324-P0001 | 1529 | FAC01515FAC00129 | FAC015-I Feel SadFAC001-Social/Family Subscale Score | FACT-HEP V4 | EMOTIONAL WELL-BEING | NOT DONE | 2 | 69 | G V4 |
| 22 | 22 | 22 |
|
| Y | 1 | 2015-05-15 | -P7D | 30 | STUDYX | QS | 2324-P0001 | 1630 | FAC01516FAC00130 | FAC015-Satisfied With How I Am CopingFAC001-Emotional Subscale Score | FACT-HEP G V4 | EMOTIONAL WELL-BEING | NOT DONE | 2 | 70 | STUDYX | QS | 2324-P0001 | 17 | FAC01517 | FAC015-Losing Hope Against Illness | FACT-HEP V4 | EMOTIONAL WELL-BEING | NOT DONE | 2 |
| 17 | 17 | 17 |
|
| Y | 1 | 2015-05-15 | -P7D | 3171 | STUDYX | QS | 2324-P0001 | 1831 | FAC01518FAC00131 | FAC015-I Feel NervousFAC001-Functional Subscale Score | FACT-HEP G V4 | EMOTIONAL WELL-BEING | NOT DONE | 2 | 72 | STUDYX | QS | 2324-P0001 | 19 | FAC01519 | FAC015-I Worry About Dying | FACT-HEP V4 | EMOTIONAL WELL-BEING | NOT DONE | 2 | 73 |
| 16 | 16 | 16 |
|
| Y | 1 | 2015-05-15 | -P7D | 32 | STUDYX | QS | 2324-P0001 | 2032 | FAC01520FAC00132 | FAC015-Worry My Condition Will Get WorseFAC001-Total Score | FACT-HEP G V4 | EMOTIONAL WELL-BEING | NOT DONE | 2 | |
| 77 | 77 | 77 |
|
| Y | 1 | 2015-05-15 | -P7D | 33 | 74 | STUDYX | QS | 2324-P0001 | 2133 | FAC01521FAC00101 | FAC015FAC001-I Am Able to WorkHave a Lack of Energy | FACT-HEP G V4 | FUNCTIONAL PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 7534 | STUDYX | QS | 2324-P0001 | 2234 | FAC01522FAC00102 | FAC015-My Work Is FulfillingFAC001-I Have Nausea | FACT-HEP G V4 | FUNCTIONAL PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 7635 | STUDYX | QS | 2324-P0001 | 2335 | FAC01523FAC00103FAC015 | -I Am Able to Enjoy LifeFAC001-Trouble Meeting Needs of Family | FACT-HEP G V4 | FUNCTIONAL PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 7736 | STUDYX | QS | 2324-P0001 | 2436 | FAC01524FAC00104 | FAC015FAC001-I Have Accepted My IllnessPain | FACT-HEP G V4 | FUNCTIONAL PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 7837 | STUDYX | QS | 2324-P0001 | 2537 | FAC01525FAC00105 | FAC015-I Am Sleeping WellFAC001-Botheredby Treatment Side Effect | FACT-HEP G V4 | FUNCTIONAL PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 7938 | STUDYX | QS | 2324-P0001 | 2638 | FAC01526FAC00106 | FAC015FAC001-Enjoy Things I Usually Do for FunI Feel Ill | FACT-HEP G V4 | FUNCTIONAL PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8039 | STUDYX | QS | 2324-P0001 | 2739 | FAC01527FAC00107FAC015 | -Content With Quality of My LifeFAC001-I Am Forced to Spend Time in Bed | FACT-HEP G V4 | FUNCTIONAL PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8140 | STUDYX | QS | 2324-P0001 | 2840 | FAC01528FAC00108FAC015 | -Swelling/Cramps in Stomach AreaFAC001-I Feel Close to My Friends | FACT-HEP G V4ADDITIONAL | CONCERNSSOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8241 | STUDYX | QS | 2324-P0001 | 2941 | FAC01529FAC00109 | FAC015-I Am Losing WeightFAC001-Get Emotional Support From Family | FACT-HEP V4G V4 | SOCIAL/FAMILY WELL-BEINGADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| 8342 | STUDYX | QS | 2324-P0001 | 3042 | FAC01530FAC00110 | FAC015FAC001-I Have Control of My BowelsGet Support From Friends | FACT-HEP G V4ADDITIONAL | CONCERNSSOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8443 | STUDYX | QS | 2324-P0001 | 3143 | FAC01531FAC00111 | FAC015-I Can Digest My Food WellFAC001-My Family Has Accepted My Illness | FACT-HEP G V4ADDITIONAL | CONCERNSSOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8544 | STUDYX | QS | 2324-P0001 | 3244 | FAC01532FAC00112 | FAC015-I Have DiarrheaFAC001-Satisfied Communication Illness | FACT-HEP G V4ADDITIONAL | CONCERNSSOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8645 | STUDYX | QS | 2324-P0001 | 3345 | FAC01533FAC00113 | FAC015FAC001-I Have a Good AppetiteFeel close to My Partner | FACT-HEP G V4ADDITIONAL | CONCERNSSOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8746 | STUDYX | QS | 2324-P0001 | 3446 | FAC01534FAC00114 | FAC015-Unhappy About Change in My AppearFAC001-I Am Satisfied With My Sex Life | FACT-HEP G V4ADDITIONAL | CONCERNSSOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8847 | STUDYX | QS | 2324-P0001 | 3547 | FAC01535FAC00115 | FAC015FAC001-I Have Pain in My BackFeel Sad | FACT-HEP G V4 | ADDITIONAL CONCERNSEMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 8948 | STUDYX | QS | 2324-P0001 | 3648 | FAC01536FAC00116 | FAC015FAC001-Satisfied With How I Am Bothered by ConstipationCoping | FACT-HEP G V4 | ADDITIONAL CONCERNSEMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9049 | STUDYX | QS | 2324-P0001 | 3749 | FAC01537FAC00117 | FAC015-I Feel FatiguedFAC001-Losing Hope Against Illness | FACT-HEP G V4 | ADDITIONAL CONCERNSEMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9150 | STUDYX | QS | 2324-P0001 | 3850 | FAC01538FAC00118 | FAC015-Able to Do My Usual ActivitiesFAC001-I Feel Nervous | FACT-HEP G V4 | ADDITIONAL CONCERNSEMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9251 | STUDYX | QS | 2324-P0001 | 3951 | FAC01539FAC00119 | FAC015-Bothered by Jaundice/Yellow SkinFAC001-I Worry About Dying | FACT-HEP G V4 | ADDITIONAL CONCERNSEMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9352 | STUDYX | QS | 2324-P0001 | 4052 | FAC01540FAC00120 | FAC015-I Have Had FeversFAC001-Worry My Condition Will Get Worse | FACT-HEP G V4 | ADDITIONAL CONCERNSEMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9453 | STUDYX | QS | 2324-P0001 | 4153 | FAC01541FAC00121 | FAC015FAC001-I Have Had ItchingAm Able to Work | FACT-HEP G V4 | ADDITIONAL CONCERNSFUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9554 | STUDYX | QS | 2324-P0001 | 4254 | FAC01542FAC00122 | FAC015-Had Change in the Way Food TastesFAC001-My Work Is Fulfilling | FACT-HEP G V4 | ADDITIONAL CONCERNSFUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9655 | STUDYX | QS | 2324-P0001 | 4355 | FAC01543FAC00123 | FAC015FAC001-I Have Had ChillsAm Able to Enjoy Life | FACT-HEP G V4 | ADDITIONAL CONCERNSFUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9756 | STUDYX | QS | 2324-P0001 | 4456 | FAC01544FAC00124 | FAC015FAC001-My Mouth Is DryI Have Accepted My Illness | FACT-HEP G V4 | ADDITIONAL CONCERNSFUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9857 | STUDYX | QS | 2324-P0001 | 4557 | FAC01545FAC00125 | FAC015-Discomfort/Pain in Stomach AreaFAC001-I Am Sleeping Well | FACT-HEP G V4 | ADDITIONAL CONCERNSFUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 9958 | STUDYX | QS | 2324-P0001 | 4658 | FAC01546FAC00126 | FAC015-Physical Subscale ScoreFAC001-Enjoy Things I Usually Do for Fun | FACT-HEP G V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 10059 | STUDYX | QS | 2324-P0001 | 4759 | FAC01547FAC00127FAC015 | -Social/Family Subscale ScoreFAC001-Content With Quality of My Life | FACT-HEP G V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| 10160 | STUDYX | QS | 2324-P0001 | 4860 | FAC01548 | FAC015-Emotional Subscale Score | FACT-HEP V4 | NOT DONE | 2 | 102 | STUDYX | QS | 2324-P0001 | 49 | FAC01549 | FAC00128 Jira |
---|
showSummary | false |
---|
server | Issue Tracker (JIRA) |
---|
serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
---|
key | QRSSUPP-668 |
---|
|
| FAC001-Physical FAC015-Functional Subscale Score | FACT-HEP G V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| 10361 | STUDYX | QS | 2324-P0001 | 5061 | FAC01550FAC00129 | FAC015-Additional Concern FAC001-Social/Family Subscale Score | FACT-HEP G V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| 10462 | STUDYX | QS | 2324-P0001 | 5162 | FAC01551FAC00130 | FAC015-Trial Outcome Index FAC001-Emotional Subscale Score | FACT-HEP G V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| 10563 | STUDYX | QS | 2324-P0001 | 5263 | FAC01552FAC00131 | FAC015-FACT-G Total FAC001-Functional Subscale Score | FACT-HEP G V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| 10664 | STUDYX | QS | 2324-P0001 | 5364 | FAC01553FAC00132 | FAC015FAC001-Total Score | FACT-HEP G V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
|
|
|
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.
QSSCAT alignment with QSTESTCD
As stated in Section 3.1 assumptions, Assumptions, items on the FACT-HEP G V4 are grouped into subcategories. The following table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.
QSSCAT | QSTESTCD |
---|
PHYSICAL WELL-BEING | FAC01501 FAC00101 - FAC01507FAC00107 |
SOCIAL/FAMILY WELL-BEING | FAC01508 FAC00108 - FAC01514FAC00114 |
EMOTIONAL WELL-BEING | FAC01515 FAC00115 - FAC01520FAC00120 |
FUNCTIONAL WELL-BEING | FAC01521 - FAC01527 | ADDITIONAL CONCERNS | FAC01528 - FAC01545FAC00121 - FAC00127 |
All QSTESTCDs
QSORRES | QSSTRESC | QSSTRESN |
---|
Not at all | 0 | 0 |
A little bit | 1 | 1 |
Somewhat | 2 | 2 |
Quite a bit | 3 | 3 |
Very much | 4 | 4 |
...