Challenges and Training Needs for Clinical Research Associates—A Survey

Clinical research associates (CRAs) perform a vital role in monitoring clinical trials. Monitoring undertaken without adequate CRA training, including competency assessment and following a monitoring methodology, can spell disaster.1 Frequent changes in regulations across global regions, variances in participation across multinational and multicenter trials, development issues faced by newer sites, and challenges associated with complex […]

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Research Compliance: Intellectual Property—Protecting Patents, Trademarks, Copyrights, and Trade Secrets

Among the enumerated powers granted to the federal government by the U.S. Constitution is the power to “promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”1 Intellectual property rights balance the incentive for innovative thought and creative expression […]