Blinding and Unblinding of an Individual Sample Clauses

Blinding and Unblinding of an Individual. Subject This study will be double-blinded. Subjects, investigators, other site personnel, and Sponsor (and/or designee) personnel (except as described below) who are directly involved in the conduct of the study, collection of the data, and analysis of the final safety and efficacy results will remain blinded to treatment assignments until after the completion of the study and the database has been locked. Sponsor (or designee) personnel will have access to unblinded individual subject treatment assignments for the purposes of study-required activities, including management of study treatment inventory, and performance of bioanalytical analysis of PK. These personnel will not be directly involved in the conduct of the study. The IRT system will be programmed with blind-breaking instructions. Blinding codes should only be broken in emergency situations for reasons of subject safety. If the blind is broken, the investigator should immediately inform (within 24 hours) the Sponsor’s Medical Monitor (or designee). The date, reason why the blind was broken, and the names of the personnel involved must be recorded in the source documentation. The date and reason why the blind was broken will also be collected in the electronic case report form (eCRF). The subject for whom the blind has been broken will be discontinued from the study and undergo the end of treatment (EOT) procedures as specified in SoA. Appropriate personnel at the Sponsor will unblind suspected unexpected serious adverse reactions (SUSARs) for the purpose of regulatory reporting. The Sponsor will submit SUSARs to regulatory agencies in blinded or unblinded fashion according to local law. The Sponsor will submit SUSARs to investigators in a blinded fashion. In order to reduce risk of breaking the blind, starting on Day 1 (baseline), investigators, the study staff, the CRO personnel, and the Sponsor’s study team will not receive absolute or relative neutrophil and WBC count results. A Medical Monitor will review the blinded data and ensure that the safety of all enrolled subjects is preserved. Absolute and relative neutrophil and WBC count results will only be disclosed to the respective investigators if the ANC reach values below the reference range of the lower limit of normal (LLN) for the central laboratory, in which case immediate actions will be taken, as described in Figure 2 (Section 6.5.2).
Sample 1
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