Questionnaires (QS) :

DEFINITION :  The Questionnaires (QS) domain captures responses to standardized questionnaires given to subjects during the clinical trial. These may include quality of life assessments, mental health evaluations, or symptom checklists.

PURPOSE : To gather subjective data directly from the subjects, which can be used to assess patient-reported outcomes and quality of life during the trial.

STRUCTURE : One record per questionnaire per question per time point per visit per subject

TOPIC : QSTESTCD

KEY VARIABLES : STUDYID, USUBJID, QSCAT, QSTESTCD, VISITNUM, QSTPTREF, QSTPTNUM