Evaluating the evaluators - Developing evidence of quality oversight effectiveness for clinical trial monitoring: Source data verification, source data review, statistical monitoring, key risk indicators, and direct measure of high risk errors

Background: Detailed information about clinical trial quality typically is not published in primary publications. This is a significant issue for physicians, advisory groups, and regulators. In addition, the efficacy of methods to find critical errors that affect trial integrity has not been tested....

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Bibliographic Details
Main Authors: Bhatt, D.L (Author), Manasco, P. (Author)
Format: Article
Language:English
Published: Elsevier Inc. 2022
Subjects:
Online Access:View Fulltext in Publisher