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Revision History

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

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These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All instrument documentation can be found on the CDISC web site at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC web site at: https://www.cdisc.org/about/bylaws.

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Although FDA has provided input with regard to this supplement, this input does not constitute FDA endorsement of any particular instrument.

2 Copyright Status

While the PRO-CTCAE is in the public domain, this measure is copyrighted and available from the the Division of Cancer Control and Population Sciences in the The NATIONAL CANCER INSTITUTE (NCI)  at the NATIONAL INSTITUTES OF HEALTH (NIH) (TBD). CDISC has included the NCI) owns the copyright for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

 instrument and has made the it exempt from copyright restrictions. Use of the PRO-CTCAE V1.0 is subject to NCI terms of use (See https://healthcaredelivery.cancer.gov/pro-ctcae/terms_of_use.html). CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument. 

While the PRO-CTCAE is in the public domain, this measure is copyrighted and available from the the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE (NCI) at the NATIONAL INSTITUTES OF HEALTH (NIH) (TBD). CDISC has included the CDISC acknowledges the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, for the approval to include the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 in the CDISC data standards.

Reference for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020:

The PRO-CTCAE trademark items and information herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, U.S.A. Use of the PRO-CTCAE is subject to NCI’s "Terms of Use" and the "Instrument & Form Builder". https://healthcaredelivery.cancer.gov/pro-ctcae/. Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).J Natl Cancer Inst 2014 Sep 29;106(9). pii: dju244. doi: 10.1093/jnci/dju244.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 are listed below.

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 as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges the Sandra Mitchell, PhD, CRNP, Research Scientist and Program Director Scientific Lead, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Outcomes Research Branch; Healthcare Delivery Research Program Division of Cancer Control and Population Sciences, National Cancer Institute, for the approval to include the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 in the CDISC data standards.

Reference for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020:

The PRO-CTCAE trademark items and information herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, U.S.A. Use of the PRO-CTCAE is subject to NCI’s "Terms of Use" and the "Instrument & Form Builder". https://healthcaredelivery.cancer.gov/pro-ctcae/. Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).J Natl Cancer Inst 2014 Sep 29;106(9). pii: dju244. doi: 10.1093/jnci/dju244.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 are listed below.

The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 a patient-reported outcome (PRO) instrument developed to capture symptomatic adverse events in patients on cancer clinical trials. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 was designed to be used in conjunction with the Common Terminology Criteria for Adverse Events (CTCAE).[1] It consists of an item library rather than a static/fixed question type of 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. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 includes multiple choice questions on the frequency. severity, interference, presence/absence and amount of adverse events.The items are rated on a 5-point scale ("0-4"). Total scoring instructions have not yet been developed.

[1] National Institutes of Health – National Cancer Institute, Division of Cancer Control & Population Sciences.  (2017, July 2) https://healthcaredelivery.cancer.gov/pro-ctcae/overview.html

1. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is an item library rather than a static/fixed

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1. 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.

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[1] National Institutes of Health – National Cancer Institute, Division of Cancer Control & Population Sciences.  (2017, July 2) https://healthcaredelivery.cancer.gov/pro-ctcae/overview.html

1. The PROAs 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 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 studyuser'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 is may be represented as a supplemental qualifier with QNAM = "QSLANG". Reference the  PRO-CTCAE website for a list of available translations.For the  PRO-CTCAE V1.0 VERSION DATE 4/26/2020, QSORRES is populated with the text description while 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: website for a list of available translations 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:.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
   2. Depending on the symptomatic AE being measured, items assessing symptom presence/absence are … 
      1. Rated on a binary response scale and scored from "0-1" (e.g., "0 = “No” and "1" = “Yes”);
      2. Rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1 " =“Yes”, and NULL= “Not applicable”); or
      3. 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”).
   3. Items assessing symptom amount are rated on a 5-point Likert
      1. scale and scored from "0-
      4
      1. 1" (e.g.
      , "0" = “Not at all”, "1" = “A little bit”
      1. , "
      2" = “Somewhat”, "3" = “Quite a bit”, and             '4 ' = “Very much”).
      1. 0 = “No” and "1" = “Yes”);
      2. Items rated on a polytomous response scale and
      Items assessing symptom frequency are rated on a 5-point Likert scale and are
      1. scored from "0-
      4
      1. 1" (e.g., "0" =
      “Never”
      1. “No”, "1 " =
      “Rarely”, "2" =“Occasionally”, "3" = “Frequently”, and "4" = “Almost constantly”).
      1. “Yes”, and NULL= “Not applicable”); or
      2. Items rated on a polytomous response scale and
      Items assessing symptom severity are rated on a 5-point Likert scale and are
      1. scored from "0-
      4
      1. 1" (e.g., "0" =
      “None”
      1. “No”, "1" =
      “Mild”
      1. “Yes”,
      "2" = “Moderate”, "3" = “Severe”, and "4" = “Very severe”
      1. NULL= “Not sexually active”, and NULL= “Prefer not to answer”).
   4. Items assessing symptom interference amount 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" and             '4 ' = “Very much”). 
   5. 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.

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. 2. 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”).
   3. 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”).
   4. 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”). 
   5. Item-level scores are not combined (e.g., no total score nor symptom-specific scores are calculated).

9. Conditional branching is used in the conduct of If the instrument standards currently being developed includes logically skipped items, insert:  'Some items on the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be logically skipped per the instrument instructions.  Language to be used for this assumption is currently under review.'

   This language is currently under review. Remove this point if it does not apply.:  Some items on the

   /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.  Responses for logically skipped items should be (1) recorded and/or scored according to the instructions provided in the instrument’s user manual, scoring manual, or other documentation provided by the instrument developer and (2) included in the submission dataset.  If such instructions are not available, then records for logically skipped items should be included in the submission dataset with:
   ·       QSSTAT = NOT DONE;
   ·       QSREASND = LOGICALLY SKIPPED ITEM; and
   ·       QSORRES, QSSTRESC, and QSSTRESN all set to null
   1. 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).

10. 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

    When submitting data to FDA or some other regulatory authority to support regulatory review of a medical product, if the electronic data collection system is not capable of automatically populating records for logically skipped items, these records should be post-populated prior to submission and the sponsor will need to explain this in the corresponding reviewer's guide

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11. 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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The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for one 1 subject collected at the baseline visit for a PRO-CTCAE V1.0 VERSION DATE 4/26/2020 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

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