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Revision History

© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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. 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.

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CDISC acknowledges WPS for the approval to include the CDRS-R in the CDISC data standards.

Reference for the (CDRS CDRS-R):

• Children's Depression Rating Scale, Revised (CDRS-R). Copyright 1995 by WESTERN PSYCHOLOGICAL SERVICES. Not to be reproduced in whole or in part without written permission. All rights reserved.
• More information on the CDRS-R can be found on the WPS website at:https://www.wpspublish.com/store/p/2703/cdrs-r-childrens-depression-rating-scale-revised.

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1. The 17 scale points include a numeric rating (1-5 or 1-7) and a definition of what is represented by various ratings of either 1, 3, 5, or 7 (e.g., 1 = "Performance is consistent with ability", 3 = "Decrease in school performance and/or ability to concentrate", etc.). Not all scores in the rating of each symptom have a definition. For the CDRS-R, RSORRES is populated with the text description when it exists and is represented by the numeric value when there is no corresponding definition, while only the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
   

   1. According to the CDRS-R manual, if a particular symptom area cannot be assigned a numeric rating on the basis of existing information, then the abbreviation "NR" (RSORRES = "Not Rated", RSSTRESC = "NR") should be written in the box where a rating is expected.

2. The RSSCAT variable represents the "Comparison of Symptom Ratings from All Sources" section on page 1 of the CRF. The RSSCAT response set includes "CHILD", "MOTHER", "FATHER", "COMBINED PARENTS", "PARENT", and "OTHER". Also included in RSSCAT is the "BEST DESCRIPTION OF CHILD" from this same section, which the examiner rates based on all of the interviewees responses. 
   

3. The CDRS-R instrument includes 3 subtotals, a raw summary score (17-113), a T-Score, a percentile rank, and a categorical T-Score range that are collected on the CRF and considered as captured data on the CRF and is not considered as derived in the example below.
   

   1. These subtotals and summary results are only captured on the child interview. Individual symptom scores can be compared between all interviewees on the first page of the Administration Booklet in the section "Comparison of Symptom Ratings from All Sources".
   2. The Percentile rank, T-Score, and T-Score range are obtained from the "scoring thermometer" and the "Interpretation of the CDRS-R T-Score" sections located on the first page of the Administration Booklet. These results cannot be operationally derived.
   3. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL 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 (--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 4.1.8.1, Origin Metadata for Variables).
4. If the interview was conducted by a parent or other adult, they stop rating the symptoms after symptom 14. Symptoms 15, 16 and 17, along with the raw summary score, T-Score, percentile rank, and categorical T-Score range are also not represented based on Chapter 3 of the user manual describing interpretative considerations.

5. The

   evaluator is stored in RSEVAL. For CDRS-R, the evaluator is defined as the "EXAMINER". Alternatively, if only evaluator name or initials could be collected: For CDRS-R,

   CRF preprinted "Examiner" (i.e., administrator performing the evaluation) is represented in SUPPRS with the QNAM = “RSPPRADM” and QLABEL = “Preprinted Administrator”. The collected examiner name or initials is represented is presented in SUPPRS with the QNAM = “RSCOLAVL” and QLABEL = “Collected Administrator Value”. For CDRS-R, 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"). The

    The CDRS-R manual defines the examiner as a properly trained professional, including psychiatric clinicians, family practitioner, social workers, pediatricians, school psychiatrists, and school nurses.

6.  The The CRF preprinted " Interviewee” (i.e., respondent providing responses) is represented in SUPPRS with the QNAM = “RSPPRRES” and QLABEL = “Preprinted Respondent”. The set of individual Interviewee values displayed “Interviewee” responses listed on page 1 of the CRF are represented with a nonstandard variable QNAM = "RSINTRVRSCOLRVL" in SUPPRS related to the RSSCAT variable. The QVAL responses include "CHILD", "MOTHER", "FATHER", "COMBINED PARENTS", and "OTHER". A new value of "combined Combined parents" interview was added to indicate the parents conducted the interview together. The The "Other (specify):" item on the CRF is represented with the collected interviewee value that was written on the line represented with variable QNAM = "RSOTHSPCRSOTHRSP".
7. Some responses to the CDRS-R symptoms exceeded the 200 character limit for the RSORRES variable and needed to be reduced to 200 or less characters. Section 4, SDTM Mapping Strategy indicates which symptom responses were revised in order to fit the 200 character limit.

8. Terminology:

   1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

   2. A list of value sets for the qualifier and result field is provided in Section 4, SDTM Mapping Strategy.

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The table represents the symptoms items from the CDRS-R instrument for the three interviews plus the "Best Description of Child" that are distinguished by values in the variable RSSCAT. Actual comments for the 17 symptoms are represented with values of "Comment text" in the example. If a comment was not made, it would not be represented in the dataset. The "MOTHER", "OTHER", and "BEST DESCRIPTION OF CHILD" interview symptoms are abbreviated to show the range of symptoms for those interviews in order to maintain a manageable example.

The interviewees question CRF preprinted "Examiner" (i.e., administrator performing the evaluation) and preprinted " Interviewee” (i.e., respondent providing responses) are represented in SUPPRS. The collected interviewees listed at the top of the CRF is are a more detailed representation of the interviewees listed in the "Comparison of Symptom Ratings from All Sources" section on page 1 of the CRF. This is represented with the QNAM = "RSTINRVRSPPRRES". The Other specify interview interviewee is represented in SUPPRS with the QNAM = "RSOTHSPCRSOTHRSP", QLABEL = "Other Respondent specify" and QVAL = "TEACHER" in this example. The "When Sleep Disturbance Occurs"  in QSTESTCD RSTESTCD = "CDRS104", three SUPPRS variables are needed to indicate the "all that apply" results with QNAM = " RSSLPDS1"," RSSLPDS2", and" RSSLPDS3". The "Type of Appetite Disturbance"  is also a non-standard variable related to QSTESTCD RSTESTCD = "CDRS105" and represented in SUPPRS with QNAM = "RSAPPDST" respectively.

4 SDTM Mapping Strategy

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