Abstract
D&MD' s Guide to Good Clinical Practice, 3rd Edition updates the regulations
and their respective amendments since the 2nd edition was published in 2005.
The guide details the duties of the sponsors, institutional review boards
(IRB), investigators, and trial monitors. Practical advice is given on the
various mandates for achieving GCP compliance. The templates of forms for
study audits, data integrity checks and IRB operations are included for the
reader' s access.
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