ABSTRACT: "This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) [...] that may carry out important aspects of clinical trial monitoring [...]"
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NOTE: FDA released a new Guidance Draft - August 2017
ABSTRACT: This guidance finalizes the draft guidance On the Establishment and Operation of Clinical Trial Data Monitoring Committees" November 2001 [...]
EMA Committee for Medicinal products for human use (CHMP)
ABSTRACT: This Guideline document deals with independent Data Monitoring Committees. It is intended as an overview guide to highlight the key issues involved when sponsors include data monitoring committees as [...].
FDA Guidance for Industry
ABSTRACT: FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether it is sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices.
The eAdjudication® software platform streamlines the overall Endpoint Adjudication process. It improves the accuracy of the data, reduces bias, provides immediate results - all of which lead to more timely decisions. Increasing the quality and integrity of the data reduces bias and patient risk - especially in multicenter studies with subjective or image-based endpoints. Establishing an endpoint map created through the charter template, as well as the real-time reporting of results, encourages thinking in a framework that may otherwise not occur without this process and software. Flagging data immediately enables quicker needed adjustments. Saving time, saving money and maybe even lives.
eAdjudication
software solution
service description
Request your FREE copy of the Adjudication Charter Guide built by Ethical after reviewing more than 20 study charters. Adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats.
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In the vast majority of cases, the studies are intended for a regulatory submission seeking marketing authorization for our drugs. So, what do regulators think about CEC Endpoint adjudication?
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Are you planning to submit Endpoint Adjudication Data to the FDA or the EMA? Submitted material are not only essential for obtaining marketing authorization but also a reflection of the quality of your company’s work.
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