Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Clinical Performance Study Plan (contd.)

• (y) procedures for communication of test results outside the study, including communications of test results to the performance study subjects; • (z) Policy as regards the establishment of the clinical performance study report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 2.2 • (aa) List of the technical and functional features of the device indicating those that are covered by the performance study. • (ab) Bibliography. Where any of the above-mentioned elements are not deemed appropriate for inclusion in the CPSP due to the specific study design chosen (e.g. use of left over samples versus interventional clinical performance studies), a justification shall be provided.

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How to meet the Clinical Evidence Requirements Literature Review - Lessons from Medical Devices

• The literature search protocol should include : • the literature search methodology - developed and executed by persons with expertise in information retrieval; • the sources of data that will be used and a justification thereof; • database search strategy (search extent); • .... • exact search terms and any limits; • limits for start and end dates of each search; • selection/criteria (such as inclusion/exclusion criteria) to be applied; • …

• The appraisal plan; • The analysis plan .

April 13, 2023

www.qarad.com

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