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By Mindy J. Allport-Settle
* a short description of the heritage and improvement of scientific study and sturdy scientific practice
* name 21 CFR elements eleven, 50, fifty four, fifty six, fifty eight, 210, 312, 314, 320, 511, 514, 601, 812, and 814
* FDA and ICH GCP criteria for medical learn
* shape FDA 1572-Statement of Investigator
* educated Consent
* sufferer Recruitment
* nation criteria and GCP
* resource Data/Documentation
* Investigator/Site requisites
* medical tracking
* scientific examine safeguard Reporting
* scientific Trial Protocols/Protocol Changes/Protocol Violations
* Institutional evaluate forums
* caliber insurance Activities/Study Auditing/FDA Inspections
* Investigational Drug responsibility, management, and Labeling
Read or Download Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations PDF
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Extra info for Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations
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Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations by Mindy J. Allport-Settle
by Anthony
4.5