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The concept of a Data Monitoring Committee (DMC), widely used in the management of randomized clinical trials, is adapted to provide this monitoring function. The rationale for the post\u2010marketing approval DMC is considered in the context of the risk management paradigm, as well as in the more traditional post\u2010marketing approval surveillance setting. The composition and operation of the post\u2010marketing approval DMC are considered, as well as the process of implementing the committee. Although the adaptation proposed in this article is focused on the paradigm proposed by the United States Food and Drug Administration, it is likely that it will require modification as risk management is adopted (and adapted) by other health regulators. Copyright \u00a9 2003 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/pds.873","type":"journal-article","created":{"date-parts":[[2004,5,18]],"date-time":"2004-05-18T17:02:01Z","timestamp":1084899721000},"page":"381-385","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacoepidemiology 101: data monitoring committees in the post\u2010marketing approval setting"],"prefix":"10.1002","volume":"13","author":[{"given":"David E.","family":"Lilienfeld","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2003,6,19]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780090804"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(88)90034-7"},{"key":"e_1_2_1_4_2","unstructured":"FDA.Guidance for clinical trial sponsors. On the establishment and operation of Clinical Trial Data Monitoring Committees. 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