We assure that a final report has been prepared for the Institutional Review Board (IRB). We ensure that the report includes, but is not limited to, study conduct and outcome, pertinent safety and efficacy observations, complete disclosure of any SAEs experienced during the course of the study, and the study close-out date.
An announcement on the study outcomes for submission to the properly identified bodies per sponsor and/or protocol, including a report on study progress has been prepared by Investigator. We assist the sites in producing their reports as needed. Arrangements for the removal and shipment of any study specific equipment received by the site (e.g., computers, diagnostic equipment, and participant monitoring devices) have been made.
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