Clinical research law and compliance handbook /

Steiner, John E.

Clinical research law and compliance handbook / edited by John E. Steiner, Jr. - Sudbury, Mass. : Jones and Bartlett, 2006. - xxx, 460 p. : ill., forms ; 24 cm.

Includes bibliographical references and index.

Practical legal and compliance issues in clinical trials / John steiner, editor -- Contract issues in domestic clinical trials / Donna J. Meyer -- Clinical research billing : process and monitoring issues / John E. Steiner, Jr., F. Lisa Murtha -- Clinical research trials : operational and budget issues / Bill Hunt, Sue O'Connell -- Fraud & abuse in clinical research / Karen Owen Dunlop and William A. Sarraille -- Uses and disclosures of identifiable information in clinical research : national and international considerations / M. peter Adler, Jeffrey G. Micklos -- Identifying applicable laws and reducing key risks in non-registrational post-marketing studies / Judith E. Beach, Nancy Strehlow -- Key compliance issues for institutional review Boards / Michael J. Meehan, and Marleina Thomas Davis -- Conflicts of interest in biomedical research - avoiding bias / Kendra Dimond and Joseph B. Clamon -- Enhancing data quality and patient safety through the use of technology in clinical trials / Jeffrey A. Green and Marc Shlaes -- Legal issues in the conduct of multinational clinical trials / by Jan E. Murray -- Clinical trials in the courtroom / Andrew Agati.

0763747254


Clinical trials--Law and legislation--United States.
Medicine--Research--Law and legislation--United States.
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