Food & Drug Administration (FDA)

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Clinical Handbooks

The Master GCP Combination Handbooks
GCP - 11, 50, 54, 56, 312, 314 & ICH E2A & E6
GCP - 11,50,54,56,312,314,E2A,E6 & EU Clin. Dir.
 

Individual Booklets - 5 book minimum
Part 50 - Protection of Human Subjects

Part 54 - Financial Disclosure by Investigators

Part 56 - Institutional Review Boards
Part 312 - Investigational New Drug Application
Part 314 - Applications to Market a New Drug
Parts 50, 54 & 56 Handbook
EU Clinical Trials Directives
GCP - Part 11 & 'Computerized Systems Guidance'


 

Laboratory Handbooks

Part 58 - Good Laboratory Practice GLP
Parts 58 GLP & Part 11


 


 
 
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