Common use of Screening Period Clause in Contracts

Screening Period. After the Informed Consent Form (ICF) is signed, subjects will enter the Screening Period for assessment of eligibility. During the Screening Visit, subject’s medical and surgical history will be reviewed including allergic history. Review of medical history will include the specific cohort disease history and history of co-morbidities. Prior and concomitant medications, therapies and procedures will be recorded. Subjects will be instructed on the required washout for specific excluded medications. ▇▇▇▇▇ ▇▇▇▇▇ and body weight will be measured, and subjects will undergo a full physical examination. Clinical laboratory tests and an ECG will be performed. Urine drug screen and pregnancy test (if applicable) will also be performed. To be eligible for study participation, subjects must have moderate to severe pruritus, defined as WI-NRS ≥ 7 at the Screening Visit and a mean weekly WI-NRS ≥ 5 for each of the 2 consecutive weeks immediately prior to randomization. A minimum of 85% compliance with daily WI-NRS recording during the last 14 days of Screening Period prior to randomization is required for eligibility unless approved by the Sponsor. At the Screening Visit, subjects will be asked to rate their pruritus severity (WI-NRS) in the previous 24 hours on a numerical rating scale. Subjects also will be instructed to record their daily rating of WI-NRS and two sleep parameters, difficulty falling asleep NRS and sleep quality NRS, from the beginning of screening to Day 1. The daily recordings (WI-NRS, difficulty falling asleep NRS, and sleep quality NRS) will continue throughout the study for eligible subjects that proceed to dosing. Furthermore, subjects with CIU will be instructed to also complete on a daily basis the UAS7 questionnaire (on itch and hives severity) from the beginning of screening to Day 1. Daily completion of the UAS7 questionnaire will continue throughout the study for eligible CIU subjects that proceed to dosing. Additional assessments at the Screening Visit include those related to pruritus (Pruritus VAS, and 5-D Pruritus), sleep (Sleep Loss VAS) and quality of life (DLQI and ItchyQoL). Collection of adverse events and concomitant medications will begin after signing the ICF and will continue until the EOS Visit. For a Schedule of Activities, please see Appendix 1.

Screening Period. After the Informed Consent Form informed consent form (ICF) is signed, subjects will enter the Screening Period for assessment of eligibility. During the Screening Visit, subject’s medical and surgical history will be reviewed including allergic history. Review of medical history will include the specific cohort disease history and history of co-morbidities. Prior and concomitant medications, therapies and procedures will be recorded. Subjects will be instructed on the required washout for specific excluded medications. ▇▇▇▇▇ ▇▇▇▇▇ and body weight will be measured, and subjects will undergo a full physical examination. Clinical laboratory tests and an ECG will be performed. Urine drug screen and pregnancy test (if applicable) will also be performed. To be eligible for study participation, subjects must have moderate to severe pruritus, defined as WI-NRS ≥ 7 at the Screening Visit and a mean weekly WI-NRS ≥ 5 for each of the 2 two consecutive weeks immediately prior to randomization. A minimum of 85% compliance with daily WI-NRS recording during the last 14 days of Screening Period prior to randomization is required for eligibility unless approved by the Sponsor. At the Screening Visit, subjects will be asked to rate their pruritus severity (WI-NRS) in the previous 24 hours on a numerical rating scale. Subjects also will be instructed to record their daily rating of WI-NRS and two sleep parameters, difficulty falling asleep NRS and sleep quality NRS, from the beginning of screening to Day 1. The daily recordings (WI-NRS, difficulty falling asleep NRS, and sleep quality NRS) will continue throughout the study for eligible subjects that proceed to dosing. Furthermore, subjects with CIU will also be instructed to also complete on a daily basis the UAS7 questionnaire (on itch and hives severity) from the beginning of screening to Day 1. Daily completion of the UAS7 questionnaire will continue throughout the study for eligible CIU subjects that proceed to dosing. Additional assessments at the Screening Visit include those related to pruritus (Pruritus VAS, and 5-D Pruritus), sleep (Sleep Loss VAS), dermatology life quality index (DLQI) and Itchy quality of life (DLQI and ItchyQoL). Collection of adverse events and concomitant medications will begin after signing the ICF and will continue until the EOS Visit. For a Schedule of Activities, please see Appendix 1.