Common use of Screen Failures Clause in Contracts

Screen Failures. Subjects who were excluded from the study after signing the informed consent, not meeting inclusion/exclusion criteria, and prior to randomization to product/dispense (exposure) of study product 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

Sources: Investigator Agreement

Screen Failures. Subjects who were excluded from the study after signing the informed consent, not meeting inclusion/exclusion criteria, consent and prior to randomization to and product/dispense (exposure) of study product will be considered a screen failureproduct. 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

Sources: Investigator Agreement

Screen Failures. Subjects who were excluded from the study after signing the informed consent, not meeting inclusion/exclusion criteria, consent and prior to randomization to product/dispense (exposure) of study product will be considered a screen failureproduct. The Investigator investigator must document the reason for screen failure in the subject’s case history source documentsdocuments and in EDC. Subject numbers must not be re-used.

Appears in 1 contract

Sources: Investigator Agreement

Screen Failures. Subjects who were excluded from the study after signing the informed consent, not meeting the inclusion/exclusion excursion criteria, and prior to randomization to product/dispense (exposure) of study product 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

Sources: Investigator Agreement

Screen Failures. Subjects who were excluded from the study after signing the informed consent, not meeting inclusion/exclusion criteria, consent and prior to to, randomization to product/dispense (exposure) of study product will be considered a screen failureproduct. The Investigator investigator must document the reason for screen failure in the subject’s case history source documents. Subject numbers must not be re-usedreused.

Appears in 1 contract

Sources: Investigator Agreement