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Strategies for Remote Auditing of Investigative Sites

Under federal regulation, sponsors are responsible for ensuring the integrity of safety and efficacy data submitted to the FDA to support their application; they are also responsible for ensuring clinical studies are conducted in accordance with the approved protocol. Audits are an opportunity to assess compliance and not just the quality of data, but the systems that generate that data. This web seminar will highlight the collaborative requirements for facilitating remote auditing and identify key considerations for future studies.