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

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The CDRS-R is a instrument used for evaluating depression in children. It consists of 17 items, rated on either a 5- or 7-point rating scale. There are also 3 subtotals, a raw summary score ranging from 17-113, a T-scoreScore, a percentile, and a categorical T-score Score range, which are all considered as captured data on the CDRS-R. Separate interviews with a child and parent and/or other adult are suggested to be conducted. At the conclusion of the interviews, a "Best Description of Child" is rated by the properly trained rater.

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"). 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, whereas 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-scoreScore, a percentile rank, and a categorical T-score 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. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the user manual.
   

   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 (i.e., CRF), in the Comparison of Symptom Ratings from All Sources section.
   2. The percentile rank, T-scoreScore, and T-score Score range are obtained from the "scoring thermometer" and the Interpretation of the CDRS-R T-Score section 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 scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
4. If the interview was conducted by a parent or other adult, 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 CDRS-R manual describing interpretative considerations.

5. Representation of printed admistrative information

   1. The 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 the CDRS-R, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. 

      1. 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.
   2. The CRF preprinted "Interviewee" (i.e., respondent providing the evaluation) is represented in SUPPRS with the QNAM = “RSPPRRES” and QLABEL = “Preprinted Respondent”. The set of individual “Interviewee” responses listed on page 1 of the CRF are represented with a nonstandard variable QNAM = "RSCOLRVL" and QLABEL = “Collected Respondent Value” in SUPPRS related to the RSSCAT variable. The QVAL responses include "CHILD", "MOTHER", "FATHER", "COMBINED PARENTS", and "OTHER". A new value of "COMBINED PARENTS" interview was added to indicate the parents conducted the interview together. The "Other (specify):" item on the CRF is represented with the collected interviewee value that was written on the line represented with variable QNAM = "RSOTHRSP" and QLABEL = "Other Respondent specify".
6. 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.

7. 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 following table represents the items from the CDRS-R instrument. USUBJID = "2324-P0001" includes the items from the CDRS-R instrument for the 3 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.

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