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1. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is an item library rather than a static/fixed instrument. You should use the form builder at: https://healthcaredelivery.cancer.gov/pro-ctcae/instrument.html and instructions provided by NCI to select the items to implement in your clinical study. As a CDISC QRS standard, the instrument name is provided in this supplement. As an item library, sponsors may select items from the overall library as a subset of items with the same CDISC controlled terminology as appropriate for the condiction being studied. It is the users responsibility to identify the subset of items used from the ovearll PRO-CTCAE V1.0 Item Library (Version 1.0) for this use case. The subsetted PRO-CTCAE V1.0 VERSION DATE 4/26/2020 user's instrument can be named based on the user's descretion when they  identify the specifc items being used.
2. The symptomatic AE being measured by a given item (e.g., the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Symptom Term corresponding to a given item) is stored in the SUPPQS dataset with the QNAM = "QSSYMTRM". This will match the term identified in the PRO-CTCAE V1.0 Item Library (Version 1.0).
3. Administration of PRO-CTCAE V1.0 VERSION DATE 4/26/2020 via different modes, including screen-based, interactive voice response, and paper, offers flexibility for patients and for study operations personnel.

4. The language in which the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 was administered (e.g., English, Spanish, Japanese) is collected with the Form Builder application and may be represented as a supplemental qualifier with QNAM = "QSLANG". Reference the  PRO-CTCAE V1.0 website for a list of available translations at: https://healthcaredelivery.cancer.gov/pro-ctcae/.

5. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020, QSORRES is populated with the text description and the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. Please reference the PRO-CTCAE website for more details on the scoring criteria at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html. The responses for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 are as follows:

   1. Depending on the symptomatic AE being measured, items assessing symptom presence/absence are rated as follows:
      1. Items rated on a binary response scale and scored from "0-1" (e.g., "0 = “No” and "1" = “Yes”);
      2. Items rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1 " =“Yes”, and NULL= “Not and “Not applicable”); or
      3. Items rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1" = “Yes”, NULL=  “Not sexually active”, and NULL= “Prefer not to answer”).
   2. Items assessing symptom amount are rated on a 5-point Likert scale and scored from "0-4" (e.g., "0" = “Not at all”, "1" = “A little bit”, "2" = “Somewhat”, "3" = “Quite a bit”, and             '4 ' = “Very much”).
   3. Items assessing symptom frequency are rated on a 5-point Likert scale and are scored from "0-4" (e.g., "0" = “Never”, "1" = “Rarely”, "2" =“Occasionally”, "3" = “Frequently”, and "4" = “Almost constantly”).
   4. Items assessing symptom severity are rated on a 5-point Likert scale and are scored from "0-4" (e.g., "0" = “None”, "1" = “Mild”, "2" = “Moderate”, "3" = “Severe”, and "4" = “Very severe”).
   5. Items assessing symptom interference are rated on a 5-point Likert scale and are scored from "0-4" (e.g., "0" = “Not at all”, "1" = “A little bit”, "2" = “Somewhat”, "3 ' = “Quite a bit”, and "4" = “Very much”). 
   6. Item-level scores are not combined (e.g., no total score nor symptom-specific scores are calculated).

6. Conditional branching is used in the conduct of the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 for symptom terms that have two or more items. The logic branches from frequency, then to severity, then to interference. For example, if frequency is > (greater than) never, you next pose the severity question, and if severity>none, you pose the interference question. Please reference the PRO-CTCAE website for more details on the conditional branching  approach at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

   1. These branching items on the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

      1. RSSTAT = "NOT DONE".       

      2. RSREASND = "LOGICALLY SKIPPED ITEM".
         

      3. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).

7. The time period of evaluation for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The recommended evaluation interval for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is the past 7 days. Please reference the PRO-CTCAE website for more details on the evaluation interval at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

8. Terminology

   1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

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

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