GALLIN John I.
OGNIBENE Frederick P.
2007, 430 p.
Cote : 18.1/GAL/2007
Part I. Ethical, regulatory, and legal issues
GRADY Christine/ 2. Ethical principles in clinical research
EMANUEL Ezekiel/ 3. Researching a bioethical question
SCHWARTZ Joan/ 4. Integrity in research : individual and institutional responsibility
WICHMAN Alison/ 5. Institutional review boards
FRIEDMAN Lawrence/ 6. Data and safety monitoring boards
TOMPKINS Anne/ 7. Data management in clinical trials
STRAUS Stephen/ 8. Unanticipated risk in clinical research
ZOON Kathryn et al./ 9. The regulation of drugs and biological products by the Food and Drug Administration
KVOCHAK Patricia/ 10. Legal issues
NUSSENBLATT Robert et al./ 11. Rules to prevent conflict of interest for clinical investigators conducting human subjects research
KELTY Miriam et al./ 12. National Institutes of Health policy on the inclusion of women and minorities as subjects in clinical research
LOWELL BUTLER Susan/ 13. Clinical research : a patient perspective
BURKLOW John/ 14. The clinical researcher and the media
Part II. Biostatistics and epidemiology
Part III. Technology transfer, protocol development, funding and other issues