Pre-Randomization Assessments Sample Clauses

Pre-Randomization Assessments. The following assessments must be completed at Visit 2 to confirm that the patient is eligible for randomization. Upon arrival at the clinic, the following assessments should be done, preferably in this order: • Assess occurrence of adverse events • Update medical history (with changes since screening noted) • Assess changes in medication history and concomitant medications • Obtain vital signs and weight • Administer CAPS-5 - “Symptom Severity Version”, using 1-week recall • Conduct urine drug screen (urine dipstick, only as necessary, if select Visit 1 tests were positive for excluded medications that required discontinuation prior to randomization) • Conduct urine pregnancy test (for women of child-bearing potential) • Perform visual examination of the oral cavity • Have the patient complete the following outcome scales (in order): o SDS o PROMIS scale for sleep disturbance o MTRSS (assessment of sedation) o CSFQ-14 o BDI-II (needs to be completed prior to the C-SSRS and reviewed by the C-SSRS rater at outset of C-SSRS interview) • Administer the C-SSRS- Since Last Visit Version (with rater review of BDI-II prior to starting C-SSRS interview)
Sample 1
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Related to Pre-Randomization Assessments

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