Screen Fail Criteria Sample Clauses
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 patient who is excluded from the study enrollment is considered a screen failure. All screen failures must be documented with the reason for the screen failure adequately stated. Subjects may be rescreened at a later date if it is anticipated that they will meet eligibility criteria.