Page History

Topic

QRS FAQ

Annotation Placement

Format

----EVAL/--EVALID

27-Oct-2021: Team decided that --EVAL/–EVALID variables should variables should not be annotated on the CRF. (See the explanation below in the QRS supplement section)

Response sets

Topic

ADQRS FAQ

Footenote the instrument's reference document 

Topic

ADQRS FAQ

ADaM Supplements

15-Jul-2015: The team reviewed the ADaM

ADaM Supplements

15-Jul-2015: The team reviewed the ADaM QRS teams concerns with having a single QRS Supplement to handle both the SDTM and ADaM dataset creation. It was agreed to have separate supplements for each. The Web page QRS Supplement table was reviewed and it was decided that it would be best to have separate rows within each QRS measure to indicate the SDTM and ADaM dataset creation supplement documents separately.

Topic

QRS FAQ

Comment Questions

18-Jan-2017: QRS COMMENT question implementation summary.

QRS Summary on How Comments, Descriptive or Explanatory text is handled

1. QRS measures that include a general COMMENTS question that encompasses general comments across the entire CRF (usually at the bottom of a CRF page) are stored in the COMMENTS (CO) domain. This will work whether the dataset consists of a single QRS measure or multiple QRS measures in determining the relationship of the comment to the QRS record:
2. The RDOMAIN variable with represent either the QS, FT, or RS domain.
3. The IDVAR and IDVARVAL variables represent the QRS measure in which the comment is requested as: IDVAR=--CAT and IDVARVAL=”the value of –CAT”, since the comment is associated with the QRS measure CRF. 
4. The COREF variable is not populated in the QRS comment representation.
5. The COEVAL variable is a permissible variable and is not populated if the –EVAL value is populated on the source QRS measure domain. It would be redundant to populate this field in this case.
6. The VISITNUM variable is permissible and is added to the CO domain file. The value is associated with the visit number in which the comment was made.
7. The CODTC variable is permissible and is used with value will equal to the –DTC variable value for the date of the comment in which the QRS measure is represented.

The ASEX-FEMALE and ASEX-MALE QS supplements can be referenced as examples on implementing this type of comment in a QRS measure.

1. QRS measures that include additional questions such as –TESTCD=DESCRIB or EXPLAIN, which are viewed as more details about a specific question on the CRF are represented as a new –TEST in the domain. This additional information is specific to a question and is considered additional data related to the question and not considered a general comment.

Copyright

27-Apr-2016: The TAUGs are using copyright status terms that don't necessarily agree with the terms used by this team. These should be harmonized. During the discussion, this team felt that our current use of "Not granted" is too broad as it includes both a "no" response (denied) and no response received (after ~3 requests). Suggestion was to add "No response received" to the TAUG list (Dana) and to re-categorize the QRS list on the web from "Not granted" to "Denied" or "No response received." The action item form the 4/27 meeting was reviewed to update the NOT GRANTED list of QRS measures with terms used for the TAUG QRS section to be more specific on why the measure was not granted permission. These will include: Denied and No Response Received in the revisions to this table.

--EVAL/–EVALID not included in QRS domains/datasets

27-Oct-2021: History: SDTMIG v3.3 was published in November, 2018; reviews started a year earlier. When reviews for SDTMIG v3.3 were in progress, meetings had already been happening with the FDA about logically skipped items and evaluator for a long time, but it was too late to change anything in the SDTMIG and we didn't have a solution yet anyway.   I began draft recommendations for changing --EVAL in February, 2019. (There are QRS subteam notes from 2013 and 2014 where the QRS team was discussing the problems with --EVAL) There were ongoing discussions thru early 2020 regarding --EVAL. The earliest documented decision that I found stating we won't be using --EVAL for QRS is in the QRS Subteam meeting notes for 2020-04-01, but it may have appeared in earlier minutes as well. (The QRS subteam space has all minutes.)

Historically, if the value was not collected on the CRF, the SDS QRS supplements had an assumption as to what the value of --EVAL should be based on the CRF and whatever other information was had about the instrument. In practice, --EVAL has been used many, many ways, with several variations of planned and actual investigator, making it difficult to know what it truly means when you see a value in the variable and making pooling of data next to impossible.

In addition, evaluator is rarely collected on a CRF and more often than not, it's not called "evaluator". EPDS has "Administered/Reviewed by"; ADCS-ADL MCI has "Examiner initials"; DAD has "Respondent" and "Rater"; "DRS has "Name of Person Completing Form"; GOSE has "Respondent" and "Interviewer", etc. Of all of the instruments that CDISC has created QRS supplements for, there are less than 2 dozen instruments that collect administrative information, and I don't have even one example where it was called "evaluator".

In all of those datasets where there's a value for --EVAL, what is it really? interviewer? respondent? examiner? person completing form? and is it planned? or actual? and what is it really for those that have nothing on the form or in the instructions (when instructions actually exist)? Hopefully this all helps clarify the problem.

So now we only represent administrative information if it is explicitly collected on an instrument. No assumptions are made for any of this kind of data; if it's not on the CRF, it's not in the data. We have held several webinars and stated it often in QRS subteam meetings to try and spread the word.

The suppquals we are using now are a series of non-standard variables that represent collected administrator value, administration device, etc., and Steve is in the process of getting these added to the non-standard variable registry. For example, we have QSCOLAVL which is "Collected Administrator Value" and QSCOLRVL which is "Collected Respondent Value".

We're also in the process of developing a QX domain for SDTMIG v4.0, which will be a QRS reference domain.  We'll give an update on QX in future QRS Subteam meetings as it recently went thru CDISC Internal Review, but one of the use cases will be to show what the CRF has for preprinted administrator, preprinted respondent, etc. So if the QRS instrument has places for "Interviewer", "Respondent", etc, these values would be in QX so we know what the instrument has on it.

The CDISC definition of the of the questionnaire (QS) domain in SDTMIG is “A findings domain that contains data for named, stand-alone instruments designed to provide an assessment of a concept. Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis.”

Many of sponsor’s general visual analog scale (VAS) and numeric rating scale (NRS) type instruments meet this definition and the QRS subteam has been approached many times seeking input on how they could be developed. Based on the definition above, the QRS subteam views each of these different general VAS or NRS instruments as separate QRS type instruments based on a specific topic, unless items can be grouped together under a specific concept/name of a QRS instrument. The QRS subteam decided, based on this variability and the inventory of existing standard QRS instruments to develop, that these general VAS or NRS instruments will not be developed as CDISC QRS standards. These types of unique sponsor general VAS and NRS instruments were reviewed with the SDSELT meeting on 3/26/18. https://wiki.cdisc.org/pages/viewpage.action?pageId=54289510&src=contextnavpagetreemode The subteam needs to draft some guidance on this for sponsors in the future, Sponsors may choose to define and create custom general VAS or NRS datasets based on the questionnaires (QS) domain. As more guidance on this topic is created, it will be posted on the QRS Best Practices WIKI page

--ORRES

27-Oct-2021: Original results stored in QSORRES when greater than the 200 characters limit currently mandated by the FDA, and hence, CDISC: To accommodate this situation in QSORRES the QRS Subteam has decided to shorten the responses to accommodate the 200 character limit without removing the clear meaning of the result. The original and shortened values are summarized in the QRS Supplement. Section 4 of the QRS supplements will include the origianl and shortened repsonses for reference.

--ORRES

27-Oct-2021: QRS Subteam decided that QSORRES values should be in the same case as the printed results on the instrument itself. Public domain QRS instrument's repsones are in the process of being included in the CDISC controlled terminology. The QRS CT team approves this controlled terminology. This is a step in implementing the QRS instruments in the CDISC Library.

--ORRES

22-May-2013: Team discussed QSORRES rules around case sensitivity and Yes/No vs. Y/N. Our rule is that QSORRES should represent the result text exactly as presented on the instrument itself, including case, punctuation, and spelling. Exceptions are: text > 200 characters may be abbreviated; reference text that merely qualifies a result may be omitted (for example, use just “Very Mild” for “Very Mild: e.g., occasionally exhibits poor eye contact”). Should there be a case where result choices are not pre-printed on the instrument, in the reference, or in a supplemental “key”, then SDTM controlled terminology should be used (e.g. Y or N for Yes or No).

--ORRES

14-Aug-2013: For a question in the “check-all-that-apply” format, a separate test code will be assigned for each of the items in the checklist. For items that are checked, use “CHECKED” as the result; for items that are not checked, use “NOT CHECKED” as the result. If the checklist is not completed at all based on a certain response to an opening question, the checklist items are considered null and not submitted in SDTM. 

--ORRES

11-Sep-2013: The QRS Subteam reviewed the follow-up on QSORRES for the SDS instruments. Through various e-mail exchanges among with the QRS Subteam, the favored approach for QSORRES is to concatenate number and text for cases where text applies to more than one number. Examples: 1-Mildly, 2-Mildly. Action: This is the decision until a better solution is developed (e.g. metadata solution).

--ORRES

--ORRES

07-May-2014: Decision by team is to use any text for QSORRES if text is available, else use number. This routinely applies to Low/High reposnes on visual analog scales (VAS) items and numeric rating scale items. This is consistent also with feedback we received from FDA a couple of years ago (Amy Malla). Team also discussed and decided that SUPPQS should hold the endpoint values (until a better “metadata solution” is developed.

--STRESN

--STRESC

QRS Batteries

17-Sep-2014: QRS Battery Implementation was decided with the SDS team. It was decided to follow the simple rule to produce the CT lists for any instrument (including a summary or battery) that we have copyright permission for. Treat each instrument including a battery/summary as independent items and develop terminology specifically for that item. Do not consider syncing question from an individual QRS instrument with the QRS battery. Any relationships between questions can and should be described in the Define file and/or the SDTM Reviewers Guide. CAT values can be created whether copyright permission is held or not. So all instruments and batteries/summaries that have developed terminology should have a defined --CAT value also. In the case of a battery/summary where we don’t have copyright for the individual instrument --CAT values should also be defined for the individual instruments when we are aware of those. See the embedded Meeting minutes with the attachments explaining this decision. 2014-08-25 SDS Extended Leadership Team Meeting Notes 2014-09-08 SDSLT Meeting Notes

QRS Derivation

05-Dec-2018 update to 30-Apr-2014: The QRS derivation continually surfaces with the QS Subteam. The previous QRS Subteam and terminology team decision was that if a total or subtotal score is not listed on the CRF it is not included in the QRS CT and not represented in SDTM. Many instruments have totals and subtotals described in their documentation, user manuals, or they are supplied to sponsors as part of eData. Additional derivations may also be provided to be part of the ADaM analysis representation of the data with CT to enable analysis and further data integration. Based on these known reasons, the QRS Subteam has agreed on the following rules for “Total” type scores in QRS datasets.

1. QRS subtotal, total, etc. scores listed on the CRF are considered as captured data and are included in the instrument’s controlled terminology.
2. QRS subtotal, total, etc. scores not listed on the CRF, but documented in an associated instrument manual or reference paper are considered as captured data and are included in the instrument’s controlled terminology.
3. QRS subtotal, total, etc. scores not listed on the CRF, but known that they can be included in eData by sponsors are considered as captured data and are included in the instrument’s controlled terminology.

05-Dec-2018 update to 27-May-2015: subtotal and Total scores represented in QRS domains are considered as capture data. There is no way for a QRS implementer to determine if the --DRVFL flag should be set based on an example CRF, without knowing the sponsor's data management processes. This is the statement for inclusion in supplements and the SDTMIG QS/FT/RS domain documents:

 The “QRS short name” total score, which is the sum of the points for each of the measures, is populated in --ORRES, --STRESC and --STRESN. Since the total score is (listed on the CRF or documented in the reference document or documented in the user manual or provided as eData to sponsors), it is considered a captured total score without any knowledge of the sponsor data management processes related to the score.

1. 1. If operationally derived 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 written on a CRF 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 SDTM Section 4.1.8.1, Origin Metadata for Variables https://wiki.cdisc.org/display/SDTMIG33/Origin+Metadata+for+Variables].

This statement will be included in any derived data assumption going forward and also added to the assumption in the QS/FT/RS domain documents for the next SDTMIG release.

QRS Naming Convention

25-May-2016: The agreement reached was that we will not use the CC abbreviation when stating clinical classifications in general to avoid confusion and we will use the names of Questionnaires, Functional Tests and Clinical Classifications supplements. We also will retain the plural version of Clinical Classifications;

WIKI QRS Supplement page namimg convention

2023-03-24: A new CDISC WIKI policy was implemented in March 2023 that performs automatic deletion of copies of pages over 5 years old. This action applies only to copies of pages in the version history that are 5+ years old and to versioned copies of attachments that are 5+ years old. Current, versions of pages and files is unaffected. Based on this, the QRS Supplement page names need to include the supplement version number to avoid deletion of the pages in change control with a differnt version number in 5 years. Example: Rutgeerts Score (RUTGEERTS SCORE) Supp V1.0

Comment Questions

18-Jan-2017: QRS COMMENT question implementation summary.

QRS Summary on How Comments, Descriptive or Explanatory text is handled

1. QRS measures that include a general COMMENTS question that encompasses general comments across the entire CRF (usually at the bottom of a CRF page) are stored in the COMMENTS (CO) domain. This will work whether the dataset consists of a single QRS measure or multiple QRS measures in determining the relationship of the comment to the QRS record:
2. The RDOMAIN variable with represent either the QS, FT, or RS domain.
3. The IDVAR and IDVARVAL variables represent the QRS measure in which the comment is requested as: IDVAR=--CAT and IDVARVAL=”the value of --CAT”, since the comment is associated with the QRS measure CRF. 
4. The COREF variable is not populated in the QRS comment representation.
5. The COEVAL variable is a permissible variable and is not populated if the --EVAL value is populated on the source QRS measure domain. It would be redundant to populate this field in this case.
6. The VISITNUM variable is permissible and is added to the CO domain file. The value is associated with the visit number in which the comment was made.
7. The CODTC variable is permissible and is used with value will equal to the --DTC variable value for the date of the comment in which the QRS measure is represented.

The ASEX-FEMALE and ASEX-MALE QS supplements can be referenced as examples on implementing this type of comment in a QRS measure.

1. QRS measures that include additional questions such as --TESTCD=DESCRIB or EXPLAIN, which are viewed as more details about a specific question on the CRF are represented as a new --TEST in the domain. This additional information is specific to a question and is considered additional data related to the question and not considered a general comment.

Copyright

27-Apr-2016: The TAUGs are using copyright status terms that don't necessarily agree with the terms used by this team. These should be harmonized. During the discussion, this team felt that our current use of "Not granted" is too broad as it includes both a "no" response (denied) and no response received (after ~3 requests). Suggestion was to add "No response received" to the TAUG list (Dana) and to re-categorize the QRS list on the web from "Not granted" to "Denied" or "No response received." The action item form the 4/27 meeting was reviewed to update the NOT GRANTED list of QRS measures with terms used for the TAUG QRS section to be more specific on why the measure was not granted permission. These will include: Denied and No Response Received in the revisions to this table.

--EVAL/–EVALID not included in QRS domains/datasets

27-Oct-2021: History: SDTMIG v3.3 was published in November, 2018; reviews started a year earlier. When reviews for SDTMIG v3.3 were in progress, meetings had already been happening with the FDA about logically skipped items and evaluator for a long time, but it was too late to change anything in the SDTMIG and we didn't have a solution yet anyway.   Dana Booth began draft recommendations for changing --EVAL in February, 2019. (There are QRS subteam notes from 2013 and 2014 where the QRS team was discussing the problems with --EVAL) There were ongoing discussions thru early 2020 regarding --EVAL. The earliest documented decision found stating we won't be using --EVAL for QRS is in the QRS Subteam meeting notes for 2020-04-01, but it may have appeared in earlier minutes as well. (The QRS subteam space has all minutes.)

Historically, if the value was not collected on the CRF, the SDS QRS supplements had an assumption as to what the value of --EVAL should be based on the CRF and whatever other information was had about the instrument. In practice, --EVAL has been used many, many ways, with several variations of planned and actual investigator, making it difficult to know what it truly means when you see a value in the variable and making pooling of data next to impossible.

In addition, evaluator is rarely collected on a CRF and more often than not, it's not called "evaluator". EPDS has "Administered/Reviewed by"; ADCS-ADL MCI has "Examiner initials"; DAD has "Respondent" and "Rater"; "DRS has "Name of Person Completing Form"; GOSE has "Respondent" and "Interviewer", etc. Of all of the instruments that CDISC has created QRS supplements for, there are less than 2 dozen instruments that collect administrative information, and don't have even one example where it was called "evaluator".

In all of those datasets where there's a value for --EVAL, what is it really? interviewer? respondent? examiner? person completing form? and is it planned? or actual? and what is it really for those that have nothing on the form or in the instructions (when instructions actually exist)? Hopefully this all helps clarify the problem.

So now we only represent administrative information if it is explicitly collected on an instrument. No assumptions are made for any of this kind of data; if it's not on the CRF, it's not in the data. We have held several webinars and stated it often in QRS subteam meetings to try and spread the word.

The suppquals we are using now are a series of non-standard variables that represent collected administrator value, administration device, etc., and Steve Kopko has added these to the non-standard variable registry. For example, we have QSCOLAVL which is "Collected Administrator Value" and QSCOLRVL which is "Collected Respondent Value".

We're also in the process of developing a QX domain for SDTMIG v4.0, which will be a QRS reference domain.  We'll give an update on QX in future QRS Subteam meetings as it recently went thru CDISC Internal Review, but one of the use cases will be to show what the CRF has for preprinted administrator, preprinted respondent, etc. So if the QRS instrument has places for "Interviewer", "Respondent", etc, these values would be in QX so we know what the instrument has on it.

The CDISC definition of the of the questionnaire (QS) domain in SDTMIG is “A findings domain that contains data for named, stand-alone instruments designed to provide an assessment of a concept. Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis.”

Many of sponsor’s general visual analog scale (VAS) and numeric rating scale (NRS) type instruments meet this definition and the QRS subteam has been approached many times seeking input on how they could be developed. Based on the definition above, the QRS subteam views each of these different general VAS or NRS instruments as separate QRS type instruments based on a specific topic, unless items can be grouped together under a specific concept/name of a QRS instrument. The QRS subteam decided, based on this variability and the inventory of existing standard QRS instruments to develop, that these general VAS or NRS instruments will not be developed as CDISC QRS standards. These types of unique sponsor general VAS and NRS instruments were reviewed with the SDSELT meeting on 3/26/18. https://wiki.cdisc.org/pages/viewpage.action?pageId=54289510&src=contextnavpagetreemode The subteam needs to draft some guidance on this for sponsors in the future, Sponsors may choose to define and create custom general VAS or NRS datasets based on the questionnaires (QS) domain. As more guidance on this topic is created, it will be posted on the QRS Best Practices WIKI page

2016-09-14: In the review of QRS instruments to convert from one QRS domain to another QRS domain with the new clinical classification concept, a number of instruments were defined as a hybrid of a Patient-reported outcome (PRO)
and a Clinician-reported outcome (ClinRO). In these instances the patient reported outcome is most important and the instrument will be considered a questionnaire concept and mapped to the QS domain.

2023-09-22: Team reviewed and confirmed. 

--ORRES >200-Characters

27-Oct-2021: Original results stored in QSORRES when greater than the 200 characters limit currently mandated by the FDA, and hence, CDISC: To accommodate this situation in QSORRES the QRS Subteam has decided to shorten the responses to accommodate the 200 character limit without removing the clear meaning of the result. The original and shortened values are summarized in the QRS Supplement. Section 4 of the QRS supplements will include the origianl and shortened repsonses for reference.

--ORRES case sensitivity

27-Oct-2021: QRS Subteam decided that QSORRES values should be in the same case as the printed results on the instrument itself. Public domain QRS instrument's repsones are in the process of being included in the CDISC controlled terminology. The QRS CT team approves this controlled terminology. This is a step in implementing the QRS instruments in the CDISC Library.

--ORRES as represented on CRF

22-May-2013: Team discussed QSORRES rules around case sensitivity and Yes/No vs. Y/N. Our rule is that QSORRES should represent the result text exactly as presented on the instrument itself, including case, punctuation, and spelling. Exceptions are: text > 200 characters may be abbreviated; reference text that merely qualifies a result may be omitted (for example, use just “Very Mild” for “Very Mild: e.g., occasionally exhibits poor eye contact”). Should there be a case where standardized resultsare not pre-printed on the instrument, in the reference, or in a supplemental “key”, then SDTM controlled terminology should be used (e.g. Y or N for Yes or No).

--ORRES Check boxes

14-Aug-2013 updated 21-Jul-2023: For a question in the “check-all-that-apply” format, a separate test code will be assigned for each of the items in the checklist. For items that are checked, use “CHECKED” as the result; for items that are not checked, use “NOT CHECKED” as the result. If the checklist is not completed at all based on a certain response to an opening question, the checklist items will be represented as --STAT=NOT DONE". 

--ORRES Non-QRS Data

30-May-2023: Due to the increasing use of non-QRS responses (e.g., DM, VS, RE, etc.) represented on QRS instruments, the QRS subteam re-reviewed the handling of non-QRS data relationship with the QRS domains (FT, QS, RS) to better document this process. After additional questions and consideration by the QRS subteam and review with ISMT referencing the CDASHIG V2.0 section 4.2 CRF Best Design Practices and the SDTMIG V3.4 section 4.2.6 Grouping Variables and Categorization, the following guidelines were created.

DM, SC, VS, etc. data in header or body of QRS CRFs that does not have a numeric score:

• Example CRFs
  • https://www.cdisc.org/standards/foundational/qrs/epworth-sleepiness-scale
  • https://www.cdisc.org/standards/foundational/qrs/rockport-one-mile-walk-test
• Some QRS CRFs information includes age, sex, vs, etc. QRS domains do not represent these results to avoid duplication and reconciliation of this type of data with the domain-specific data. These non-QRS responses are represented in the appropriate domains and referenced to the QRS domain as needed.
• CDISC domain definitions are predictable in nature and used to represent the data based on the definition of the response.
• CRF creation is arbitrary in the collection of items and placement on the forms.
• If sponsors need to analyze the instrument over multiple years with the subject increasing their age, they will recalculate the age from the DM: birthdate and the –DTC date from the instrument’s CRF.
• If other DM data or SC data is needed to analyze the QRS instrument’s data, these items are joined to the QRS dataset from specific data domains.

DM, VS, LB data are referenced as composite domain-specific data that is scored in clinical classification QRS instruments CRFs:

• These types of QRS Instruments do not represent the source non-QRS domain data in the QRS domain but do include scores that are a composite of data from other domains (e.g. lab tests, heart rate). The source domain-specific data is still represented in the appropriate domains and linked to the QRS related scored item as appropriate via RELREC. The composite score(s) itself is represented in the QRS domain. This QRS supplement provides the example of this use case: https://www.cdisc.org/standards/foundational/qrs/acute-physiology-and-chronic-health-evaluation-ii

DM, VS, RE, etc. responses represented on QRS instrument’s CRFs and scored are included in the QRS domain:

• Example CRF
  • https://www.cdisc.org/standards/foundational/qrs/who-disability-assessment-schedule-2-0-36-item-interviewer-administered

The following rationale determines the representation of scored non-QRS responses with the instrument’s QRS domain when used to evaluate the instrument’s responses.

• QRS instruments are “static” in collection of specific data based on its definition and concept of analysis at that point in time.
• QRS instruments collection of specific data is for a specific purpose of evaluating the instrument’s responses that is different than the independent collection and analysis of other routine data.
• In general, if the QRS instrument’s published controlled terminology for--TESTCD/--TEST includes the items as needed in the QRS domain (FT, QS or RS) as represented on the instrument.

If a QRS supplement exists for an instrument, it needs to be followed because it is likely the Regulatory Authorities will follow for the review of the QRS instrument’s supplement. This also ensures consistency across all use cases of the QRS instrument. If the QRS instrument does not have a published QRS supplement, is the QRS subteam recommends that the user follow this CDISC QRS best practice for consistency in using the instrument.

--ORRES text applying to more than 1 numeric response

11-Sep-2013: The QRS Subteam reviewed the follow-up on QSORRES for the SDS instruments. Through various e-mail exchanges among with the QRS Subteam, the favored approach for QSORRES is to concatenate number and text for cases where text applies to more than one number. Examples: 1-Mildly, 2-Mildly. Action: This is the decision until a better solution is developed (e.g. metadata solution). An example of this is seen in Sheehan Disability Scale.

--ORRES trailing punctuation

--ORRES

--STRESN

--STRESC

for VAS and NRS items

07-May-2014: Decision by team is to use any text for QSORRES if text is available, else use number. This routinely applies to Low/High reposnes on visual analog scales (VAS) items and numeric rating scale items. This is consistent also with feedback we received from FDA a couple of years ago (Amy Malla). Team also discussed and decided that SUPPQS should hold the endpoint values (until a better “metadata solution” is developed.

28-Aug-2023: Anchor text, and text appearing at other points on the scale, should be represented in ORRES, with the numeric values in STRESC and STRESN.  For example, if there is a 10-point scale with text values of NONE, MODERATE, and EXTREME corresponding to #s 0, 5, and 9, then NONE, MODERATE, and EXTREME would be represented in ORRES and 0, 5, and 9 would be represented in STRESC and STRESN.  ANCHOR values (NONE, 0, EXTREME, 9) would still be represented in the non-standard variables ANTXLO, ANVLLO, ANTXHI, ANVLHI.  The exception to this would be as above in "--ORRES text applying to more than 1 numeric response".

--ORRES

--STRESN

--STRESC

Binary responses

14-May-2022: QRS responses CT for items assessed on a binary type of response

1. When the binary response options are assigned a numeric value, the original text result will be represented in --ORRES variable, following the same case style on the instrument. The numeric value will always be represented in --STRESC/--STRESN standard variables.
   • “Yes”/ “No” assigned values 1-0 (e.g., 1 = “Yes” and 0 = “No”)
     • --ORRES = “Yes”; --STRESC/--STRESN = 1
     • --ORRES = “No”; --STRESC/--STRESN = 0
   • “True”/ “False” assigned values 1-0 (e.g., 1 = “True” and 0 = “False”)
     • --ORRES = “True”; --STRESC/--STRESN = 1
     • --ORRES = “False”; --STRESC/--STRESN = 0
2. When binary response options are not assigned a numeric value, the original text result will be represented in --ORRES variable. The abbreviated standard text value will be represented in the --STRESC standard variable in uppercase.
   • “Yes”/ “No” /"Unknown" w/o assigned numeric values
     • --ORRES = “Yes”; --STRESC = “Y”
     • --ORRES = “No”; --STRESC = “N”
     • --ORRES = “Unknown”; --STRESC = “U”
   • “True”/ “False” w/o assigned numeric values
     • --ORRES = “True”; --STRESC = “T”
     • --ORRES = “False”; --STRESC = “F”
3. When multiple (more than two) response options (e.g., a binary response and one or more additional text responses) are represented, and the additional response is not assigned a numeric value, the original text result will be represented in --ORRES variable, following the same case style on the instrument. The original text response will always be represented in --STRESC standard variables matching the case represented on the CRF.

• • “Yes”/ “No”/ “Not applicable” assigned values 1-0 (e.g., 1 = “Yes” and 0 = “No”, “Not applicable”)
    • --ORRES = “Yes”; --STRESC/--STRESN = 1
    • --ORRES = “No”; --STRESC/--STRESN = 0
    • --ORRES = “Not applicable”; --STRESC = “Not applicable”
  • “True”/ “False”/ “Not applicable” assigned values 1-0 (e.g., 1 = “True” and 0 = “False”, “Not applicable”)
    • --ORRES = “True”; --STRESC/--STRESN = 1
    • --ORRES = “False”; --STRESC/--STRESN = 0
    • --ORRES = “Not applicable”; --STRESC = “Not applicable”

Additional ORS item binary responses will follow the same pattern as they arise.

--STRESN

--STRESC

Numeric responses

QRS Batteries

17-Sep-2014: QRS Battery Implementation was decided with the SDS team. It was decided to follow the simple rule to produce the CT lists for any instrument (including a summary or battery) that we have copyright permission for. Treat each instrument including a battery/summary as independent items and develop terminology specifically for that item. Do not consider syncing question from an individual QRS instrument with the QRS battery. Any relationships between questions can and should be described in the Define file and/or the SDTM Reviewers Guide. CAT values can be created whether copyright permission is held or not. So all instruments and batteries/summaries that have developed terminology should have a defined --CAT value also. In the case of a battery/summary where we don’t have copyright for the individual instrument --CAT values should also be defined for the individual instruments when we are aware of those. See the embedded Meeting minutes with the attachments explaining this decision. 2014-08-25 SDS Extended Leadership Team Meeting Notes 2014-09-08 SDSLT Meeting Notes

QRS Derivation

05-Dec-2018 update to 30-Apr-2014: The QRS derivation continually surfaces with the QS Subteam. The previous QRS Subteam and terminology team decision was that if a total or subtotal score is not listed on the CRF it is not included in the QRS CT and not represented in SDTM. Many instruments have totals and subtotals described in their documentation, user manuals, or they are supplied to sponsors as part of eData. Additional derivations may also be provided to be part of the ADaM analysis representation of the data with CT to enable analysis and further data integration. Based on these known reasons, the QRS Subteam has agreed on the following rules for “Total” type scores in QRS datasets.

1. QRS subtotal, total, etc. scores listed on the CRF are considered as captured data and are included in the instrument’s controlled terminology.
2. QRS subtotal, total, etc. scores not listed on the CRF, but documented in an associated instrument manual or reference paper are considered as captured data and are included in the instrument’s controlled terminology.
3. QRS subtotal, total, etc. scores not listed on the CRF, but known that they can be included in eData by sponsors are considered as captured data and are included in the instrument’s controlled terminology.

05-Dec-2018 update to 27-May-2015: subtotal and Total scores represented in QRS domains are considered as capture data. This is the statement for inclusion in supplements and the SDTMIG QS/FT/RS domain documents:

 The “QRS short name” total score, which is the sum of the points for each of the measures, is populated in --ORRES, --STRESC and --STRESN. Since the total score is (listed on the CRF or documented in the reference document or documented in the user manual or provided as eData to sponsors), it is considered a captured total score without any knowledge of the sponsor data management processes related to the score. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

1. 1. Subtotal and total scores are represented in--ORRES, --STRESC, and --STRESN.
   2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.

This statement will be included in the subtotal/total score data assumption going forward and also added to the assumption in the QS/FT/RS domain documents for the next SDTMIG release.

QRS Naming Convention

25-May-2016: The agreement reached was that we will not use the CC abbreviation when stating clinical classifications in general to avoid confusion and we will use the names of Questionnaires, Functional Tests and Clinical Classifications supplements. We also will retain the plural version of Clinical Classifications;

QRS Scoring Definitions

12-Sep-2023: This document includes definitions for the concept of scored QRS instrument numeric responses, independent of how they are represented in--ORRES, --STRESC, and --STRESN.  CDISC CT will reflect specific wording used in a given instrument’s documentation.  The terms below will be used for consistency throughout CDISC supplements in referring to the concept of scoring.

Original Score – The original score is simply unaltered data from a test or observation. It is recorded in its original form by a researcher before being subjected to any statistical analysis. The original score data is a type of data that has not been weighted, derived, calculated, transformed, or converted. The QRS response for original scores includes a numeric rating and a definition of what is represented by the rating (e.g., 0 = “text description of response”). QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

• Examples of original scores are response, grade, rating, and assessment.
• Supplement examples
  • All attached CRFs to the Scaled Score below in supplement examples include examples of original scores.

Overall Score - The result of some transformation(s) applied to the original score, such as in relative grading or other mathematical computations. This is the final, overall score of the other sets of numbers, subtotals, or other statistical functions as applied to the original scores. In QRS instruments, the definition of the overall score is included in the instrument’s documentation.

• Examples of overall scores are Total Scores (the final, overall sum of the other sets of numbers or subtotals), Percentiles, Z-Scores, T-Scores, Index Scores, etc.
• Multiple overall scores in QRS instrument will be uniquely named based on the statistical function applied to the original scores.
• Supplement examples
  • Short Form 36 Health Survey Acute, US Version 2.0 (SF36 V2.0 ACUTE) Supp V1.0
  • Short Form 36 Health Survey Standard, US Version 2.0 (SF36 V2.0 STANDARD) Supp V1.0
  • Children's Depression Rating Scale, Revised (CDRS-R) Supp V1.0
  • Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4) Supp V1.0
  • Mini-Mental State Examination (MMSE) Supp V1.0
  • Psoriasis Area and Severity Index Version Feldman (PASI FELDMAN) Supp V1.0

Subscore - A score that is a subset of a larger overall score; in QRS instruments, the definition of the subscore is included in the instrument’s documentation.

• Examples are Subtotal Scores (result of adding some numbers together but is not the final overall total/ subtotal describes the total of one set of numbers that will later be added to another set to calculate the final total), Percentiles, Z-Scores, T-Scores, Subscale Scores, Index Scores, Domain Scores etc.
• Multiple subscores in QRS instrument will be uniquely named based on the statistical function applied to the original scores.
• Supplement examples
  • Mini-Mental State Examination (MMSE) Supp V1.0
  • Symptoms of Major Depressive Disorder Scale Version 1.0 (SMDDS v1.0) Supp V1.0
  • Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 (NSCLC-SAQ V1.0) Supp V1.0

--SCAT case sensitivity--SCAT

22-May-2013: Team discussed QSSCAT case sensitivity. We propose use of upper case always for consistency with QSCAT and SDTM guidance

--SCAT controlled terminology

23-Oct-2013: Use the QSCAT value in the supplement even if it differs from the commonly known instrument abbreviation. The commonly known instrument abbreviation will be contained in the QSCAT Definition in Terminology. Make a note in the supplement if applicable.

1. Sponsors should always consult the published QRS Supplements for guidance on submitting derived information in a SDTMIG QRS domain. Derived variables in QRS are normally considered captured data. If sponsors operationally derive variable results, then the derived records that are submitted in a QRS domain should be flagged by will be considered as captured data and the --DRVFL variable is not used.
   1. The following rules apply for “Total” type scores in QRS datasets.
      1. QRS subtotal, total, etc. scores listed on the CRF are considered as captured data and are included in the instrument’s controlled terminology.
      2. QRS subtotal, total, etc. scores not listed on the CRF, but documented in an associated instrument manual or reference paper are considered as captured data and are included in the instrument’s controlled terminology.
      3. QRS subtotal, total, etc. scores listed on the CRF not listed on the CRF, but known to be included in eData by sponsors are considered as captured data and are included in the instrument’s controlled terminology. The QRS instrument’s CT is considered extensible for this case and the subtotal or total score should be requested to be added.
         1. Any imputations/calculations done to numeric “standardized responses” to produce the total score via transforming numeric “standardized responses” in any way would be done as ADaM derivations.
   2. The QRS instrument subtotal , or total , etc. scores not listed on the CRF, but documented in an associated instrument manual or reference paper are considered as captured data and are included in the instrument’s controlled terminology.
   3. QRS subtotal, total, etc. scores not listed on the CRF, but known to be included in eData by sponsors are considered as captured data and are included in the instrument’s controlled terminology. The QRS instrument’s CT is considered extensible for this case and the subtotal or total score should be requested to be added.
      1. Any imputations/calculations done to numeric “standardized responses” to produce the total score via transforming numeric “standardized responses” in any way would be done as ADaM derivations.
   4. The QRS instrument subtotal or total score, which is the sum of the numeric responses for an instrument, is populated in --ORRES, --STRESC and –STRESN. It is considered a captured subtotal or total score without any knowledge of the sponsor data management processes related to the score.
      1. If operationally derived by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotal and total scores. An investigator derived score written on a CRF 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 v3.3 Section 4.1.8.1, Origin Metadata for Variables https://wiki.cdisc.org/display/SDTMIG33/Origin+Metadata+for+Variables].

Supplemental Qualifiers

29-Jun-2016: :If a QRS supplemental qualifier applies to all of the QRS --TESTCDs in a category, the IDVAR and IDVARVAL should be the --CAT or --CAT values. If it does not apply to all tests at this level they should have the specific QRS --TESTCDs to which it applies. Sponsor discretion needs to take precedence in all other cases.

--TESTCD (Missing Responses)

21-Apr-2021: 

Missing responses: Records are created in qs.xpt for every item on the instrument:

For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "LOGICALLY SKIPPED ITEM" or QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

QRS instruments with skipped items: The QRS skipped items will apply to all QRS domains (FT, QS, RS) as needed.

Some items on the QRS instruments may be logically skipped per the instrument instructions. (Ex. Only one of multiple items needs to be completed. The others will be treated as a logically skipped item.) Some items are only completed when the response to a specific item a specific response. A record is created in the QRS dataset (--.xpt) for all items. When an item is considered a logically skipped item, it is represented as follows:

RSSTAT = "NOT DONE".

RSREASND = "LOGICALLY SKIPPED ITEM".

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

--TESTCD

08-Jan- 2014: If consecutive QSTESTCDs fall within a QSSCAT, list the QSTESTCDs in the format 1 – n in the supplement mapping strategy section. If multiple, non-consecutive QSTESTCDs fall within a QSSCAT, list each individually.

Team decided to hold off on this until we see more cases and what we prefer. One issue with listing QS test codes in ranges like 1 – n is that each test code is then not searchable. But is the intent really that these supplements should be searchable?

• The QRS instrument diaries may or may not provide the necessary timing information needed to align the timing to the CDISC QRS domain variables.
• QRS diary based instruments will have the timing of the diary captures described in a protocol.
  • Protocol does not describe the timing of diary data collected relative to visits within the study.
    • VISITNUM is represented as a null value since sponsors have different operating procedures to assign visit information relative to diary collection.
      • The --DTC variable contains the date/time the diary information was collected by the subject and is used for the timing of this measure.
    • Protocol does describe the timing of dairy collected relative to visits within the study. An example is that the diary information is collected prior to the subject attending a visit in which the subject reports the diary information to the investigator to include in the study.
      • Based on the protocol’s description of diary collection timing relative to visits, the following SDTM timing variables are appropriate to use as needed to align the diary collection timing to visits.
        • VISITNUM (Visit Number) variable represents the visit number in which the subject's diary data was reported to the investigator.
        • QSDTC (Date/Time of Assessment Collection) variable represents the date the daily diary information was collected by the subject.
        • QSTPT (Planned Time Point) variable represents the planned diary day timing. (e.g., Day -2)
        • QSTPTREF (Planned Time Point Reference) variable represents the visit name the subject intends to return the diary data for inclusion in the study. (e.g., VISIT 2)
        • QSRFTDTC (Date/Time of the Reference Time Point) variable represents the visit date the subject returned diary data for inclusion in the study.
        • QSEVLINT/QSEVINTX (Evaluation Interval/ Evaluation Interval Text) variables represent the evaluation interval timing described on the instrument relative to diary collection.

Version History

19-Feb-2014: For updated supplement versions, provide a summary of changes in the Version History of the revised supplement

1. 1. score, which is the sum of the numeric responses for an instrument, is populated in --ORRES, --STRESC and –STRESN. It is considered a captured subtotal or total score without any knowledge of the sponsor data management processes related to the score.
      
      1. Subtotal and total scores are represented in--ORRES, --STRESC, and --STRESN.
      2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.

Non-Standard Variables (NSV)

29-Jun-2016 updated 04-May-2023 replacing supplemental qualifirs with non-stnadard variables: :If a QRS standard variables (NSV) applies to all of the QRS --TESTCDs in a category, the IDVAR and IDVARVAL should be the --CAT or --CAT values. If it does not apply to all tests at this level they should have the specific QRS --TESTCDs to which it applies. Sponsor discretion needs to take precedence in all other cases.

--TESTCD (Missing Responses)

21-Apr-2021 and revised 04-05-2023 for conditionally branched items: 

Missing responses: Records are created in qs.xpt for every item on the instrument:

For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

QRS instruments with skipped items: The QRSconditionally branched items will apply to all QRS domains (FT, QS, RS) as needed.

Some items QRS instruments may be conditionally branched per the instrument instructions.  A record is created in QRS dataset for all items. When an item is considered a conditionally branched item, it is represented as follows:

When assigned conditionally branched responses are not documented in the instrument’s instructions or a user manual:

1. QNAM = “--CBRFL”, QLABEL = “Conditional Branched Item Flag “, QVAL = “Y” (this is a QS supplemental qualifier variable related to the record).
2. --ORRES, --STRESC, and --STRESN are set to null (missing).

When assigned conditionally branched responses are documented in instructions or a user manual:

1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Flag “, QVAL = “Y” (this is a QS supplemental qualifier variable).
2. The --ORRES responses are represented as follows:
1. For severity items, --ORRES = "None".
2. For interference items, --ORRES = "Not at all".
3. If numeric response values are assigned, they are represented here: --STRESC = 0 and --STRESN = 0.

--TESTCD

08-Jan- 2014: If consecutive QSTESTCDs fall within a QSSCAT, list the QSTESTCDs in the format 1 – n in the supplement mapping strategy section. If multiple, non-consecutive QSTESTCDs fall within a QSSCAT, list each individually.

Team decided to hold off on this until we see more cases and what we prefer. One issue with listing QS test codes in ranges like 1 – n is that each test code is then not searchable. But is the intent really that these supplements should be searchable?

• The QRS instrument diaries may or may not provide the necessary timing information needed to align the timing to the CDISC QRS domain variables.
• QRS diary based instruments will have the timing of the diary captures described in a protocol.
  • Protocol does not describe the timing of diary data collected relative to visits within the study.
    • VISITNUM is represented as a null value since sponsors have different operating procedures to assign visit information relative to diary collection.
      • The --DTC variable contains the date/time the diary information was collected by the subject and is used for the timing of this measure.
    • Protocol does describe the timing of dairy collected relative to visits within the study. An example is that the diary information is collected prior to the subject attending a visit in which the subject reports the diary information to the investigator to include in the study.
      • Based on the protocol’s description of diary collection timing relative to visits, the following SDTM timing variables are appropriate to use as needed to align the diary collection timing to visits.
        • VISITNUM (Visit Number) variable represents the visit number in which the subject's diary data was reported to the investigator.
        • QSDTC (Date/Time of Assessment Collection) variable represents the date the daily diary information was collected by the subject.
        • QSTPT (Planned Time Point) variable represents the planned diary day timing. (e.g., Day -2)
        • QSTPTREF (Planned Time Point Reference) variable represents the visit name the subject intends to return the diary data for inclusion in the study. (e.g., VISIT 2)
        • QSRFTDTC (Date/Time of the Reference Time Point) variable represents the visit date the subject returned diary data for inclusion in the study.
        • QSEVLINT/QSEVINTX (Evaluation Interval/ Evaluation Interval Text) variables represent the evaluation interval timing described on the instrument relative to diary collection.

Version History

19-Feb-2014: For updated supplement versions, provide a summary of changes in the Version History of the revised supplement

Version History

18-May-2016: A suggestion was made to add the SDTM version in which the QRS measure was developed in the "Notes to Readers" section. After discussion and review of the QRS web page that describes the use of the RS domain, it was decided not to add this item. Based on the evolution of the standards and revised mapping and/or new variable decisions, the maintenance of all QRS historic documents for anything but major change controls will be necessary. We want to foster the approach to follow current thought processes on the QRS mapping for historic document that might be may not have used new variable approved since they were developed.

Use of --TSTDTL

27-March-2024: The variable --TSTDTL is not to be used in the QRS domains. All specifics about an item should be captured using --TEST. 

--EVLINT and --EVINTX

24-April-2024: When possible, always use EVLINT to express the evaluation interval of an instrument whether it is on the CRF itself or within the user manual. For example, if the evaluation interval is "During the last week" or "In the last week" then the EVLINT should be "-P1W"

Version History

18-May-2016: A suggestion was made to add the SDTM version in which the QRS measure was developed in the "Notes to Readers" section. After discussion and review of the QRS web page that describes the use of the RS domain, it was decided not to add this item. Based on the evolution of the standards and revised mapping and/or new variable decisions, the maintenance of all QRS historic documents for anything but major change controls will be necessary. We want to foster the approach to follow current thought processes on the QRS mapping for historic document that might be may not have used new variable approved since they were developed.