Screen Failures. Screen failures are subjects who were excluded from the study after signing the informed consent, not meeting the inclusion/exclusion criteria, and prior to randomization to product/dispense of study product. The Investigator must document the reason for screen failure in the subject’s case history source documents. Subject numbers must not be re-used.
Appears in 3 contracts
Samples: Investigator Agreement, Investigator Agreement, Investigator Agreement
Screen Failures. Screen failures are subjects Subjects who were excluded from the study after signing the informed consent, not meeting the inclusion/exclusion criteria, consent and prior to randomization to product/dispense of study product. The Investigator investigator must document the reason for screen failure in the subject’s case history source documents. Subject numbers must not be re-used.
Appears in 2 contracts
Samples: Investigator Agreement, Investigator Agreement
Screen Failures. Screen failures are subjects Subjects who were excluded from the study after signing the informed consent, not meeting the inclusion/exclusion criteria, consent and prior to randomization to product/dispense study product assignment and dispensing of study product. The Investigator investigator must document the reason for screen failure in the subject’s case history source documents. Subject numbers must not be re-used.
Appears in 2 contracts
Samples: Investigator Agreement, Investigator Agreement
Screen Failures. Screen failures are subjects Subjects who were excluded from the study after signing the informed consent, not meeting the inclusion/exclusion criteria, and prior to randomization to product/dispense (exposure) of study productproduct will be considered a screen failure. The Investigator must document the reason for screen failure in the subject’s case history source documents. Subject numbers must not be re-used.
Appears in 1 contract
Samples: clinicaltrials.gov
Screen Failures. Screen failures are subjects who were are excluded from the study after signing the informed consent, not meeting the inclusion/exclusion criteria, consent and prior to randomization to product/dispense of study productrandomization. The Investigator must document the reason for screen failure in the subject’s case history source documents. Subject numbers must not be re-used.
Appears in 1 contract
Samples: Investigator Agreement