Issues in Research Management: Protocol Challenges in the Era of Complexity

By CenterWatch
Published: November 2011

By Carolynn T. Jones, MSPH, RN; Penelope M. Jester, MPH, RN; and Meredith Fitz-Gerald, BSN, RN

Clinical research study sites and sponsors have an increasing set of challenges and responsibilities in this era of clinical research complexity and frequent protocol amendments. The increasing complexity and intensity of clinical research protocols within the past decade is validated by research conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD). This white paper will outline the site and sponsor responsibilities and challenges for protocol management in this era of increased clinical research complexity and modification.

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