Good Clinical Practice eRegs a Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: E6 Good Clinical Practice Guidance for Industry Part 11, Electronic Records; Electronic Signatures a Scope and Application CFR 21-- General Part 11, Electronic Records; Electronic Signatures 21 CFR PART 50 Protection Of Human Subjects 21 CFR Part 54 Financial Disclosure By Clinical Investigators 21 CFR PART 56 Institutional Review Boards Title 21 PART 312 Investigational New Drug Application ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH E8 General Considerations For Clinical TrialsUnder the narrow interpretation of the scope of part 11, with respectto records required to be maintained under predicate rules or submittedto FDA, when persons choose to use records in electronic format in place of paper format, part 11anbsp;...
|Title||:||Good Clinical Practice eRegs & Guides - For Your Reference Book 2|
|Author||:||eRegs & Guides, Biopharma Advantage Consulting L.L.C.|
|Publisher||:||eRegs And Guides - 2013-11-22|