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| Dataset wrap |
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| Rows 13-14: | Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX". | | Rows 15-16: | Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX". | | Row 33: | The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF. | |
| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | 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 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 2 | STUDYX | QS | 2324-P0001 | 2 | FAC01502 | FAC015-I Have Nausea | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 3 | STUDYX | QS | 2324-P0001 | 3 | FAC01503 | FAC015-Trouble Meeting Needs of Family | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 4 | STUDYX | QS | 2324-P0001 | 4 | FAC01504 | FAC015-I Have Pain | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 5 | STUDYX | QS | 2324-P0001 | 5 | FAC01505 | FAC015-Botheredby Treatment Side Effect | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 6 | STUDYX | QS | 2324-P0001 | 6 | FAC01506 | FAC015-I Feel Ill | FACT-HEP V4 | A little bit | 1 | 1 |
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| 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 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 8 | STUDYX | QS | 2324-P0001 | 8 | FAC01508 | FAC015-I Feel Close to My Friends | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 9 | STUDYX | QS | 2324-P0001 | 9 | FAC01509 | FAC015-Get Emotional Support From Family | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015-I Get Support From Friends | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 11 | STUDYX | QS | 2324-P0001 | 11 | FAC01511 | FAC015-My Family Has Accepted My Illness | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 12 | STUDYX | QS | 2324-P0001 | 12 | FAC01512 | FAC015-Satisfied Communication Illness | FACT-HEP V4 | Very much | 4 | 4 |
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| Y | 1 | 2015-05-15 | -P7D | | 13 | STUDYX | QS | 2324-P0001 | 13 | FAC01513 | FAC015-I Feel close to My Partner | FACT-HEP V4 | Very much | 4 | 4 |
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| Y | 1 | 2015-05-15 | -P7D | | 14 | STUDYX | QS | 2324-P0001 | 14 | FAC01514 | FAC015-I Am Satisfied With My Sex Life | FACT-HEP V4 |
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| 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 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 16 | STUDYX | QS | 2324-P0001 | 16 | FAC01516 | FAC015-Satisfied With How I Am Coping | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 17 | STUDYX | QS | 2324-P0001 | 17 | FAC01517 | FAC015-Losing Hope Against Illness | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 18 | STUDYX | QS | 2324-P0001 | 18 | FAC01518 | FAC015-I Feel Nervous | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 19 | STUDYX | QS | 2324-P0001 | 19 | FAC01519 | FAC015-I Worry About Dying | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 20 | STUDYX | QS | 2324-P0001 | 20 | FAC01520 | FAC015-Worry My Condition Will Get Worse | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 21 | STUDYX | QS | 2324-P0001 | 21 | FAC01521 | FAC015-I Am Able to Work | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 22 | STUDYX | QS | 2324-P0001 | 22 | FAC01522 | FAC015-My Work Is Fulfilling | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 23 | STUDYX | QS | 2324-P0001 | 23 | FAC01523 | FAC015-I Am Able to Enjoy Life | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 24 | STUDYX | QS | 2324-P0001 | 24 | FAC01524 | FAC015-I Have Accepted My Illness | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 25 | STUDYX | QS | 2324-P0001 | 25 | FAC01525 | FAC015-I Am Sleeping Well | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 26 | STUDYX | QS | 2324-P0001 | 26 | FAC01526 | FAC015-Enjoy Things I Usually Do for Fun | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 27 | STUDYX | QS | 2324-P0001 | 27 | FAC01527 | FAC015-Content With Quality of My Life | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 28 | STUDYX | QS | 2324-P0001 | 28 | FAC01528 | FAC015-Swelling/Cramps in Stomach Area | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 29 | STUDYX | QS | 2324-P0001 | 29 | FAC01529 | FAC015-I Am Losing Weight | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 30 | STUDYX | QS | 2324-P0001 | 30 | FAC01530 | FAC015-I Have Control of My Bowels | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 31 | STUDYX | QS | 2324-P0001 | 31 | FAC01531 | FAC015-I Can Digest My Food Well | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 32 | STUDYX | QS | 2324-P0001 | 32 | FAC01532 | FAC015-I Have Diarrhea | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 33 | STUDYX | QS | 2324-P0001 | 33 | FAC01533 | FAC015-I Have a Good Appetite | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 34 | STUDYX | QS | 2324-P0001 | 34 | FAC01534 | FAC015-Unhappy About Change in My Appear | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 35 | STUDYX | QS | 2324-P0001 | 35 | FAC01535 | FAC015-I Have Pain in My Back | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 36 | STUDYX | QS | 2324-P0001 | 36 | FAC01536 | FAC015-I Am Bothered by Constipation | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 37 | STUDYX | QS | 2324-P0001 | 37 | FAC01537 | FAC015-I Feel Fatigued | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 38 | STUDYX | QS | 2324-P0001 | 38 | FAC01538 | FAC015-Able to Do My Usual Activities | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 39 | STUDYX | QS | 2324-P0001 | 39 | FAC01539 | FAC015-Bothered by Jaundice/Yellow Skin | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 40 | STUDYX | QS | 2324-P0001 | 40 | FAC01540 | FAC015-I Have Had Fevers | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 41 | STUDYX | QS | 2324-P0001 | 41 | FAC01541 | FAC015-I Have Had Itching | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 42 | STUDYX | QS | 2324-P0001 | 42 | FAC01542 | FAC015-Had Change in the Way Food Tastes | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 43 | STUDYX | QS | 2324-P0001 | 43 | FAC01543 | FAC015-I Have Had Chills | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 44 | STUDYX | QS | 2324-P0001 | 44 | FAC01544 | FAC015-My Mouth Is Dry | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 45 | STUDYX | QS | 2324-P0001 | 45 | FAC01545 | FAC015-Discomfort/Pain in Stomach Area | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 46 | STUDYX | QS | 2324-P0001 | 46 | FAC01546 | FAC015-Physical Subscale Score | FACT-HEP V4 | 6 | 6 | 6 |
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| Y | 1 | 2015-05-15 | -P7D | | 47 | STUDYX | QS | 2324-P0001 | 47 | FAC01547 | FAC015-Social/Family Subscale Score | FACT-HEP V4 | 19 | 19 | 22.2 | 22.2 | 22.219 |
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| Y | 1 | 2015-05-15 | -P7D | | 48 | STUDYX | QS | 2324-P0001 | 48 | FAC01548 | FAC015-Emotional Subscale Score | FACT-HEP V4 | 9 | 9 | 9 |
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| Y | 1 | 2015-05-15 | -P7D | | 49 | STUDYX | QS | 2324-P0001 | 49 | FAC01549 | FAC015-Functional Subscale Score | FACT-HEP V4 | 16 | 16 | 16 |
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| Y | 1 | 2015-05-15 | -P7D | | 50 | STUDYX | QS | 2324-P0001 | 50 | FAC01550 | FAC015-Additional Concern Subscale Score | FACT-HEP V4 | 22 | 22 | 22 |
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| Y | 1 | 2015-05-15 | -P7D | | 51 | STUDYX | QS | 2324-P0001 | 51 | FAC01551 | FAC015-Trial Outcome Index Score | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 52 | STUDYX | QS | 2324-P0001 | 52 | FAC01552 | FAC015-FACT-G Total Score | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 53 | STUDYX | QS | 2324-P0001 | 53 | FAC01553 | FAC015-Total Score | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D |
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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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For QRS instruments with subcategories:
When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.
QSSCAT alignment with QSTESTCD
As stated in Section 3.1 assumptions, items on the
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FACT-HEP V4 are grouped into subcategories. The 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.
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If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:
"All QSTESTCDs"
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| PHYSICAL WELL-BEING | FAC01501 - FAC01507 |
| SOCIAL/FAMILY WELL-BEING | FAC01508 - FAC01514 |
| EMOTIONAL WELL-BEING | FAC01515 - FAC01520 |
| FUNCTIONAL WELL-BEING | FAC01521 - FAC01527 |
| ADDITIONAL CONCERNS | FAC01528 - FAC01545 |
All QSTESTCDs
QSORRES | QSSTRESC | QSSTRESN |
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| Not at all | 0 | 0 |
| A little bit | 1 | 1 |
| Somewhat | 2 | 2 |
| Quite a bit | 3 | 3 |
| Very much | 4 | 4 |
End of Document