Agent GCP and the Bloody Consent Form GuidebookAgent GCP is THE way to learn FDA regulations. The exciting, suspenseful, and sometimes zany plot of a murder in a clinical trial is interweaved with interactivity and teaching of FDA regulations in an unforgettable manner. At the completion, learners will have obtained a superb knowledge of informed consent and IRB regulations. This course covers all the regulations on informed consent procedures and Institutional Review Boards (IRBs)—that is, Good Clinical Practices in 45 CFR 46, 21 CFR 50, 21 CFR 56, and other regulations. It is useful for any person or organization participating in clinical trials. The book contains useful aids including a glossary, a list of resources, model consent forms, and texts of regulations. Those readers who wish to have an accompanying program with interactivity should also purchase the CD version. |
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Contents
I | 1 |
II | 2 |
III | 4 |
IV | 21 |
V | 26 |
VI | 42 |
VII | 49 |
VIII | 59 |
XVI | 154 |
XVII | 182 |
XVIII | 200 |
XIX | 213 |
XX | 257 |
XXI | 258 |
XXII | 259 |
XXIII | 279 |
Common terms and phrases
Access granted access to LEVEL additional Agency head Agent GCP Answer applicable appropriate Authenticate access Authentication granted Belmont Report blood CARMATE Cheerasil study clinical trial conducted consent form Department or Agency depression DHHS Drug Administration elements of informed ERETIC ethical exemption Federal fetus Food and Drug Guidelines Hayworthless Heckle HERETIC individual informed consent informed consent document Initiating Institutional Review Board intelligence computer displayed investigational new drug involving human subjects IRB approval IRB review legally authorized representative Level 1 accessed means Michele minimal risk NIH MPA Nuremberg Code obtained Office OHSR participation patients PEA WHIZ person Pharm Mission Control physician prisoners Question RACECAR DRIVER Ravennaire Red Raven regulations research activities research involving human research subjects review and approval rights and welfare sponsor subpart system displayed System Stroke test article treatment True or false TRUSTWORTHY TY BREAKER understand VICT
Bibliographic information
| Title | Agent GCP and the Bloody Consent Form Guidebook |
| Authors | Daniel Farb, Bruce Gordon |
| Publisher | UniversityOfHealthCare, 2005 |
| ISBN | 1594912785, 9781594912788 |
| Length | 332 pages |
| Subjects | › Medical / General |
| Export Citation | BiBTeX EndNote RefMan |