CDISC QS Controlled Terminology, 2013-04-12 NCI Code CDISC Submission Value Codelist Name CDISC Definition Codelist Extensible C103482 PHQ-15 TEST Patient Health Questionnaire - 15 Item Test ... Questionnaire domain. SDTM Fundamentals • SDTM Variable Classification: 1.) Background In the spring 2015, all of the (at that time) 12 current TAUGs were examined. SDTM Implementation guide provides documentation on metadata (data of data) for the domain datasets that includes filename, variable names, type of variables and its labels etc. The SDTM, which should be read before this Implementation Guide, describes a general conceptual model for representing clinical study data that is submitted to regulatory authorities. SDS V3.1 provides specific domain models, assumptions, business rules, and examples for preparing standard datasets that are Example 3: The RELREC domain is used to help the reader understand relations between data from diff erent SDTM domains. Identifier : These are the variable which identifies the study, subject involved, domain and sequence number. The medical history domain MH is used as an example to determine the amount of variation within a specific domain.

The representation of data collected for this questionnaire is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) QS domain table, (SDTMIG), which can be found at the CDISC website at http://www.cdisc.org/sdtm.

SDTM Domain Abbreviation: C160924: SDTM IG Version Response: C132263: SDTM Microscopic Findings Test Code: C132262: SDTM Microscopic Findings Test Name: C116111: SDTM Species: C160923 : SDTM Version Response: C115408: Satisfaction With Life Scale Questionnaire Test Code: C115407: Satisfaction With Life Scale Questionnaire Test Name: C124302: Schizophrenia Findings … PROC CDISC now provides data content checking against the domain definitions provided by the SDTM. Domain: Collecon of observaons with common topic. 7. SDTM.QSis designed for capturing the patients' questions info. Abnormal Involuntary Movement Scale : AIMS : QS : Public Domain : Version: 1.0 22 May 2013.

All assumptions for the QS domain from the SDTMIG apply for this supplemental implementation guide including those referenced in the CDISC notes. The SDTM, which should be read before this Implementation Guide, describes a general conceptual model for representing clinical study data that is submitted to regulatory authorities. SDTM.QS is designed for capturing the patients’ questions info. QS domain is a questionaries domain that contains a variety of patient information about different questionnaires. 3 The QS Domain Model 3.1 Assumptions for the Pain Intensity Questionnaire Domain Model All assumptions for the QS domain from the SDTMIG apply for this supplemental implementation guide, including …