Common use of Screen Fail Criteria Clause in Contracts

Screen Fail Criteria. ‌ Any consented subject who is excluded from the study before randomization is considered a screen failure. All screen failures must be documented with the reason for the screen failure adequately stated. If a subject screen fails prior to randomization, they can be rescreened up to two times if the site staff feels they meet eligibility criteria. Rescreened subjects will have to complete all screening procedures (i.e., data from previous screenings cannot be used).

Screen Fail Criteria. ‌ Any consented subject patient who is excluded from the study before randomization is considered a screen failure. All screen failures must be documented with the reason for the screen failure adequately stated. If a subject screen fails prior to randomizationfails, they s/he can be rescreened up to two additional times if the site staff feels they meet s/he meets eligibility criteriacriteria and following confirmation from the study monitor. Rescreened subjects will have to complete all screening procedures (i.e., data from previous screenings screening cannot be used).