Showing posts from the year 2015

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  • All the activity of a clinical study culminates in the production of a clinical study report (CSR). More than a written summary of the results of a study, among its contents are the protocol followed during study conduct, lists of investigators, and the statistical output and methods. If printed, a CSR could number 1000 pages or more.

  • The role and skill set of a Clinical Data Manager (CDM) is constantly changing as technology and processes advance. CDMs have evolved into data management leaders, possessing skills in areas such as database building and programming, project management, and budget maintenance, on top of the standard collection, cleaning, and management of subject data in compliance with regulatory standards.

  • Risk-based monitoring in clinical trials involves targeted monitoring that may include 100% source data verification for specified critical data points and partial source data verification of other data.

  • The number of clinical trials incorporating independent data monitoring committees (IDMCs) for safety and efficacy monitoring is on the rise. Currently, it is recommended that late-stage trials with a major morbidity or mortality endpoint, or studies in vulnerable patient populations with a large enrollment, use an IDMC to review the interim safety and efficacy data.