Annotate Questionnaires with help of QRS Supplement

[james-eda]

• [ ] Review SDTM IG 3.4 for Questionnaires (QS), a domain that is part of the QRS set of domains
• [ ] Example: FACIT.org's FAACT v4 + Scoring https://www.facit.org/measures/faact
• [ ] Annotate the CRF using CDISC Controlled Terminology
• [ ] Annotate the Scoring sheet

Next:

• Simulate an entry and Double-program (SAS versus R) the above using the annotated CRF and scoring sheet above as specification https://wiki.cdisc.org/pages/viewpage.action?pageId=165090986

Soon:

• Open source validated code use to perform scoring for this questionnaire given standardized study data
• Apply process to SilentNight-MT-CSR (annotate questionnaire, score it to derive SDTM and/or ADaM variables, and create macro to score other assessments)

[james-eda]

Here is the Controlled Terminology worksheet

SDTM Controlled Terminology used for QSTEST, QSTESTCD, QSSTRESC, QSORRES available here: https://datascience.cancer.gov/resources/cancer-vocabulary/cdisc-terminology

[james-eda]

Noted: This task may not directly relate to mock trial deliverables; rather, it is a clean example of the process in preparation for QS in the mock trial. Plus, we're contributing to open source (I'm sure someone will search for the SAS and R code to save time scoring this correctly)

Noted: This will take longer than 2 hours. Yes, I have the curse of knowledge.

Thank you kindly!