Guideline on When to Use AP-QRS Domains vs. QRS Domains for QRS Instruments Related to Associated Persons

Scenarios 1 and 2

For a QRS instrument,

Scenario 1: Associated Persons (e.g., caregiver, child, parent) who answer questions for and about themselves: Data intended to obtain information about someone other than the subject (unrelated to the subject) should be captured in the APQS, APFT, or APRS domains.

Scenario 2: Associated Persons (e.g., caregiver, child, parent) who answer questions on behalf of a subject (acting as a subject proxy): When a subject is unable to respond for themselves (e.g., due to cognitive or speech impairment), information is considered subject data and should be modeled in the QS, FT, and RS domains.

For more information regarding APQS, refer to <Study Data Tabulation Model Implementation Guide: Associated Persons, Version 1.0>, section 3.3.4.

Scenario 3

If a single questionnaire contains items about BOTH the associated person and the subject/participant, then map all items to the QS domain. For example, in the Resource Utilisation in Dementia (RUD) Questionnaire Baseline Case Report Form (revised as RUD Lite v.4), the first 17 items are about the associated person (e.g., caregiver), and the last 27 items are about the subject/participant. Patient-reported data is the highest priority, thus data for this instrument is represented in the QS domain only. Do not split the data between the APQS and QS domains. The AP variables APID, RSUBJID, and SREL may be included as non-standard variables (NSVs). USUBJID must be represented for ALL items on the instrument in the QS domain because it is a required variable per the SDTMIG and can NOT be null.

Similarly, if a functional test or clinical classification contains data about the associated person as well as data about the subject/participant, it should be mapped to the FT or RS domain (do not split the data into APFT and APRS), respectively.

A single set of CAT and TEST-CD terminology will be created in these cases.

To distinguish between the associated person and the subject/participant within the same instrument, we recommend either or both of the following approaches (however it fits your mapping needs).

1.         Incorporate the associated person and the subject/participant (e.g. “Caregiver” and “Patient”) directly into the TEST NAME stem text of each item (abbreviate as needed to fit the TEST 40-character limit) – note, the Test Names below are for illustrative purposes:

• XXX01 – Caregiver: Age

• XXX01 – Caregiver: Relationship to Patient

• Include the word Caregiver in the CDISC definition as well.

• XXX01 – Patient: Living Accommodation

• XXX01 – Patient: Live With

• Include the word Patient in the CDISC definition as well.

1. Alternatively, use --SCAT to distinguish between the associated person and the subject/participant (i.e., map the values of Caregiver and Patient to --SCAT).

Below is an example modeling using RUD LITE V4 for Scenario 3, Option 1. The first 17 items in RUD LITE V4 are about the caregiver, whereas items 18-44 are about the subject/participant. Please note that some variables have been omitted from the QS example below for viewing clarity. The table below does NOT use official CT and is provided for illustrative purposes only. We understand that QSSEQ 1-17 are AP data, but USUBJID must be populated with the unique subject ID (e.g., DEM-011-011 below) because QSSEQ 1-17 are caregiver data of the specific subject DEM-011-011. We prioritize patient-reported outcomes in this instance, which means we map the entire instrument to the QS domain