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Question 16 contains Part A “Loss of WT According to Patient” and Part B “Loss of WT According to WK Meas”. Only one of the questions is answered when administering the HAMD-17 questionnaire. In this example Part A is answered and Part B is shown for illustration purposes only with RSORRES=XXX, RSSTRESC=XXX and RSSTRESN=XXX.
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Note: There are several optional space-saving options that can be included in the paragraph as appropriate or needed. Historically, we needed these to save space in Word/PDF documents. As we move to all wiki/html, these are likely not needed, but we are waiting to remove these options until we're sure: - "This example is based on a clinical classification with an evaluation interval of xxx." allows the QSEVLINT (or QSEVINTX) column to be removed from the example. Note that it was not used for the IDS-SR instrument used in the example below as it is not the same for all items.
- "This example is based on a clinical classification with an evaluation interval of the past week. QSLOBXFL is NULL based on VISITNUM = 2." saves space if there are a large number of columns. If this statement is used, leave off the QSEVLINT, QSLOBXFL and VISITNUM columns in the example.
- "QSSTRESN is null as there are no standardized numeric results for this instrument." This statement is used when there are no standardized numeric values. The QSSTRESN column is then removed from the below example.
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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. |
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 The table represents the items from the HAMD 17 form.
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| Row 17: | Represents question 16 Part B for illustration purposes only. This row would not be included in the actual dataset, since Part A of this question is answered. | | Row 19: | Represents the total score. All total scores are considered as captured data unless the sponsor operationally derives it via an EDC system.
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| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSLOBXFL | VISITNUM | RSEVLINT | | 1 | | | Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSLOBXFL | VISITNUM | RSEVLINT | | 1 | STUDYX | RS | 2324-P0001 | 1 | HAMD101 | HAMD1-Depressed Mood | HAMD 17 | Absent. | 0 | 0 | Y | 1 | -P1W | | 2 | STUDYX | RS | 2324-P0001 | 2 | HAMD102 | HAMD1-Feelings of Guilt | HAMD 17 | Self reproach, feels he/she has let people down. | 1 | 1 | Y | 1 | -P1W | | 3 | STUDYX | RS | 2324-P0001 | 31 | HAMD103HAMD101 | HAMD1-SuicideDepressed Mood | HAMD 17 | Ideas or gestures suicideAbsent. | 303 | 0 | Y | 1 | -P1W | | 42 | STUDYX | RS | 2324-P0001 | 42 | HAMD104HAMD102 | HAMD1-Insomnia Early - Early NightFeelings of Guilt | HAMD 17No | difficulty falling asleepSelf reproach, feels he/she has let people down. | 010 | 1 | Y | 1 | -P1W | | 53 | STUDYX | RS | 2324-P0001 | 53 | HAMD105HAMD103 | HAMD1-Insomnia Middle - Middle NightSuicide | HAMD 17 | No difficultyIdeas or gestures suicide. | 030 | 3 | Y | 1 | -P1W | | 64 | STUDYX | RS | 2324-P0001 | 64 | HAMD106HAMD104 | HAMD1-Insomnia Early Hours - MorningEarly Night | HAMD 17 | No difficulty falling asleep. | 0 | 0 | Y | 1 | -P1W | | 75 | STUDYX | RS | 2324-P0001 | 75 | HAMD107HAMD105 | HAMD1-Work and ActivitiesInsomnia Middle - Middle Night | HAMD 17 | No difficulty. | 0 | 0 | Y | 1 | -P1W | | 86 | STUDYX | RS | 2324-P0001 | 86 | HAMD108HAMD106 | HAMD1-RetardationInsomnia Early Hours -Morning | HAMD 17 | Complete stuporNo difficulty. | 404 | 0 | Y | 1 | -P1W | | 97 | STUDYX | RS | 2324-P0001 | 97 | HAMD109HAMD107 | HAMD1-AgitationWork and Activities | HAMD 17 | FidgetinessNo difficulty. | 101 | 0 | Y | 1 | -P1W | | 108 | STUDYX | RS | 2324-P0001 | 108 | HAMD110HAMD108 | HAMD1-Anxiety PsychicRetardation | HAMD 17 | No difficultyComplete stupor. | 040 | 4 | Y | 1 | -P1W | | 119 | STUDYX | RS | 2324-P0001 | 119 | HAMD111HAMD109 | HAMD1-Anxiety SomaticAgitation | HAMD 17 | ModerateFidgetiness. | 212 | 1 | Y | 1 | -P1W | | 1210 | STUDYX | RS | 2324-P0001 | 1210 | HAMD112HAMD110 | HAMD1-Somatic Symptoms GIAnxiety Psychic | HAMD 17 | NoneNo difficulty. | 0 | 0 | Y | 1 | -P1W | | 1311 | STUDYX | RS | 2324-P0001 | 1311 | HAMD113HAMD111 | HAMD1-General Anxiety Somatic Symptoms | HAMD 17 | NoneModerate. | 020 | 2 | Y | 1 | -P1W | | 1412 | STUDYX | RS | 2324-P0001 | 1412 | HAMD114HAMD112 | HAMD1-Genital Somatic Symptoms GI | HAMD 17 | MildNone. | 101 | 0 | Y | 1 | -P1W | | 1513 | STUDYX | RS | 2324-P0001 | 1513 | HAMD115HAMD113 | HAMD1-HypochondriasisGeneral Somatic Symptoms | HAMD 17 | Not presentNone. | 0 | 0 | Y | 1 | -P1W | | 1614 | STUDYX | RS | 2324-P0001 | 1614 | HAMD116AHAMD114 | HAMD1-Loss of WT According to PatientGenital Symptoms | HAMD 17 | Definite (according to patient) weight lossMild. | 212 | 1 | Y | 1 | -P1W | | 1715 | STUDYX | RS | 2324-P0001 | 1715 | HAMD116BHAMD115 | HAMD1-Loss of WT According to WK MeasHypochondriasis | HAMD 17XXX | Not present. | XXX0XXX | 0 | Y | 1 | -P1W | | 1816 | STUDYX | RS | 2324-P0001 | 1816 | HAMD117HAMD116A | HAMD1-InsightLoss of WT According to Patient | HAMD 17 | Denies being ill at allDefinite (according to patient) weight loss. | 2 | 2 | Y | 1 | -P1W | | 1917 | STUDYX | RS | 2324-P0001 | 1917 | HAMD118HAMD116B | HAMD1-Total ScoreLoss of WT According to WK Meas | HAMD 17 | 16XXX16 | XXX | 16XXX | Y | 1 | -P1W | | 18 | STUDYX |
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| RS | 2324-P0001 | 18 | HAMD117 | HAMD1-Insight | HAMD 17 | Denies being ill at all. | 2 | 2 | Y | 1 | -P1W | | 19 | STUDYX | RS | 2324-P0001 | 19 | HAMD118 | HAMD1-Total Score | HAMD 17 | 16 | 16 | 16 | Y | 1 | -P1W |
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The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes): Text that would remain unchanged has been left in black: The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below. | Dataset wrap |
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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STUDYX | QS | P0001 | QSSEQ | Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8) | Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT). | Label for QNAM (e.g., Contact Type) | Value of QNAM variable ( e.g., SUBJECT VISIT) | CRF
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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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