QRS supplements to the SDTMIG include instrument-specific Controlled Terminology and an SDTM example illustrating the use, applicable supplemental qualifiers and item-level mapping instructions for the results. Assumptions for implementing the instrument in SDTM are also included.
QRS supplements to the ADaMIG describe how to structure the questionnaire analysis dataset based on data structures described in the ADaMIG. Included in ADaMIG supplements are sample analysis descriptions, scoring for the statistical analysis plan, data checks, and examples of analysis dataset metadata, analysis variable metadata, and value-level metadata. Also included is an example of the final analysis dataset to be used for analysis and regulatory submission.
Yes, certain Clinical Classifications may be stored in other domains. The rule for storing Clinical Classifications is:
If the instrument is a Rating or Grading Scale in which the intent of the instrument is to evaluate a single body system, then it would be stored in the morphology/physiology domain which represents that body system (see TAUG-RA: Swollen Joint Count/Tender Joint Count Example). Other Rating or Grading Scales related to multiple body systems and all Composite Score type instruments would be represented as a Clinical Classification in the RS domain. If the data is based on microscopic data, those type of scoring instruments would be represented in the MI domain (see the PrCa-TAUG Pathology 2 – Gleason example).
- Composite types of instruments provide an assessment based on multiple individual assessments that can be represented in other domains. For example, the APACHE II is a composite instrument that has a CRF and would be stored as a Clinical Classification in the RS domain because it has a variety of labs, respiratory, and vital sign assessments in addition to the Glasgow Coma Score. This variety of data is scored separately in the APACHE II instrument. This composite scoring approach is currently represented as a Clinical Classification in the RS domain.
- Another type of Clinical Classification that is stored in the RS domain deals with the rating of symptoms or other medical conditions related to multiple body systems. These are not posed as a questionnaire with specific questions and specific answers, but have CRFs with the symptoms or medical conditions listed with a specific rating scale that is evaluated by an examiner.
- Rating and Grading Scales are instruments that may or may not use observations from multiple body systems, but there is no CRF with a place for the individual assessments' values and therefore no calculation of an overall score. For example, TIMI Grade is a grading system for coronary blood flow that has no CRF and is based on the CV body system. This Grading Scale instrument is related to a single body system and would be stored in the related morphology/physiology body system domain.
QRS supplements are represented in SDTMIG v3.2 and earlier versions in the Questionnaires (QS) domain or in custom domains. The Functional Tests (FT) and the Disease Response and Clin Classification (RS) findings domains for ratings and scales other than questionnaires will be included SDTMIG v3.3. The RS domain, originally intended for classifications of disease response, was renamed to Disease Response and Clin Classification and revised to include all clinical classifications. Submissions using SDTMIG v3.2 and earlier versions should represent ratings and scales other than questionnaires in custom domains that mirror the FT and RS domains. The terminology in published FT and RS supplements as well as the FT and RS domain codes can be used for such custom domains. The user should alert regulators of their use of the supplements in the Data Reviewers Guide.
- ADaM Basic Data Structure (BDS): An analysis dataset that contains one or more records per subject, per analysis parameter, per analysis time point. The parameters are mapped from –TEST and –TESTCD, and additional parameters are created as needed for derived scores.
- ADAM Other may also be used when the analysis has special needs that are not met by the BDS structure.
CDISC Controlled Terminology is maintained and distributed as part of the National Cancer Institute (NCI) Thesaurus and available in Excel, text, odm.xml, pdf, html and OWL/RDF formats. QRS SDTM terminology is included in the SDTM terminology download.
- Here’s an example using the Excel format of CDISC Controlled Terminology to find categories:
- In the SDTM CT spreadsheet, locate the category of the instrument in the following codelists: Category of Clinical Classification, Category of Functional Test, or Category of Questionnaire.
- Next, search for the instrument’s –TESTCD and –TEST codelists by using category’s CDISC Synonym(s) value in searching all CDISC Submission Values. The instrument’s “test code” and “test name” codelists will be provided.
- Here’s an example using the Excel format of CDISC Controlled Terminology to find terminology for The Satisfaction With Life Scale:
- Go to the top of the spreadsheet and search for ‘Satisfaction With Life’.
- This brings you to the instrument’s entry in the Category of Questionnaire (QSCAT) codelist.
- The cells in this row starting at the far left:
- EVS and Codelist C-codes for NCI reference use.
- Codelist Name for the name of the codelist (“Category of Questionnaire”).
- CDISC Submission Value which is the value of QSCAT for the instrument (SWLS).
- CDISC Synonym(s) value used to locate the –TESTCD and –TEST codelists (SWLS01).
- CDISC definition for this instrument.
- If you now search for SWLS01, you will find the –TESTCD and –TEST codelists (SWLS01TC and SWLS01TN) for The Satisfaction With Life Scale.
- The QRS Terminology Naming Rules are in the QRS Implementation Documents panel on this page.
CDISC must obtain permission to create a QRS supplement for copyrighted instruments. If this permission is not obtained, the supplement is not created.
Rights of Copyright Holders
- CDISC recognizes the copyright of all instrument copyright holders. All instrument owners maintain full copyright status when granting permission to CDISC to develop QRS supplements for the instrument. A QRS supplement does not, in any way, affect copyright holder licensing fees or procedures.
Creating QRS Supplements
- Granting CDISC the right to create supplements to represent an instrument in CDISC QRS domains is not a license for CDISC standards users to use the instrument without complying with the copyright holders licensing requirements.
- No part of a copyrighted instrument or accompanying guidelines may be reproduced, distributed, or transmitted in any form, or by any means, including photocopying, recording, or other electronic or mechanical methods without the permission of the copyright holder and payment of applicable fees.
If there is not a supplement for an instrument you are using, CDISC has not received copyright permission to develop as a standard. These instruments have Permission values of either “Denied” or “No response received”.
- Follow the instructions for requesting a QRS supplement on the QRS Standard Request Form located in the QRS Implementation Documents panel on this page.
The FDA discusses the need for outcome measures that are defined as part of the Drug Development Tools Qualification Program for Clinical Outcome Assessment (COA) instruments. CDISC QRS Supplements assist in structuring COA data so that it is collected and reported in a standardized format.
- Clinician-reported outcome (ClinRO)
- Observer-reported outcome (ObsRO)
- Patient-reported outcome (PRO)
- Performance outcome (PerfO)
|CDISC SDTM QRS Supplements||ClinRO||ObsRO||PRO||PerfO|
QRS supplements are developed following the CDISC Standards Development Process defined in COP-001 and further described in the QRS Addendum. The related QRS development process documents include:
- QRS Standard Request Form
- QRS Public Domain Copyright Verification Document
- CDISC Copyright Letter
- QRS Supplement Template (Based on appropriate domains, such as QS, FT, and RS)
- QRS Terminology Spreadsheet Example
- QRS Naming Rules
- QRS Supplement QC Checklist v2
QRS supplements are developed on the CDISC Wiki. Once developed and released, each QRS supplement can be downloaded freely from the QRS webpage to implement for data submissions.
Where permitted by the copyright holder, the supplement is accompanied by a CRF annotated with SDTMIG submission values. In addition, a supplement to the ADaMIG may be included to provide the documentation to prepare the QRS supplement analysis dataset.
Accessing the Published Supplements
The QRS standards package is available on the QRS web page. The following is a description of the column headings in the QRS published supplements table and how to access the package.
- QRS Name: Click on QRS Name to access the SDTMIG QRS Supplement, ADaMIG QRS Supplement, and/or an annotated CRF.
- Short Name: (--CAT): SDTM Short Name used to identify the QRS instrument within the SDTMIG and in Controlled Terminology.
- SDTM Domain / ADaM Dataset: Indicates the SDTM FINDINGS domain in which the SDTMIG supplement is represented. A designation of ADaM indicates an ADaMIG supplement exists for the instrument.
- Permission: Indicates the CDISC permission status of the instrument.
- Public Domain: The instrument is in the public domain; no permission is necessary.
- Granted: The copyright holder has granted CDISC permission to develop a supplement. Controlled Terminology for --CAT, --TEST, --TESTCD can also be developed. Where applicable, the SDTMIG supplement includes response values in --ORRES and scored values in –STRESC/--STRESN. This means that meaningful examples of data from the instrument can be included in supplements. Sponsors still need to obtain copyright permission from the copyright holder to use the instrument in their clinical trials.
- Author Permission Required: This permission level requires the user to obtain the CDISC QRS Supplements from the copyright holder. A README file is provided that explains how to obtain the instrument and CDISC QRS supplement(s).
- Denied: The copyright holder has denied permission to implement the QRS supplement. No supplement was developed.
- No response received: The copyright holder has not responded to attempted contacts. No supplement was developed.
- Pending: The QRS instrument’s copyright status is in review, but there is no resolution at this point in time.
- Version: Each Supplement version has a unique number.
- Release Date: Date CDISC published the QRS supplement.