Saturday 13 March 2010

Good Clinical Practice Free

Good Clinical Practice
Author: Mindy J. Allport-Settle
Edition:
Binding: Kindle Edition
ISBN: B0044XV8U0
Category: Medical



Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations


T Download Good Clinical Practice medical books for free.
pics covered include:

* A brief description of the history and development of clinical research and good clinical practice
* Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814
* FDA and ICH GCP Standards for Clinical Research
* Form FDA 1572-Statement of Investigator
* Informed Consent
* Patient Recruitment
* State Standards and GCP
* Source Data/Documentation
* Investigator/Site Requirements
* Clinical Monitoring
* Clinical Study Safety Reporting
* Clinical Trial Protocols/Protocol Changes/Protocol Violations
* Institutional Review Boards
* Quality Assurance Activities/Study Auditing/FDA Inspections
* Investigational Get Good Clinical Practice our bestseller medical books.

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Good Clinical Practice Free


ics covered include:

* A brief description of the history and development of clinical research and good clinical practice
* Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814
* FDA and ICH GCP Standards for Clinical Research
* Form FDA 1572-Statement of Investigator
* Informed Consent
* Patient Recruitment
* State Standards and GCP
* Source Data/Documentation
* Investigator/Site Requirements
* Clinical Monitoring
* Clinical Study Safety Reporting
* Clinical Trial Protocols/Protocol Changes/Protocol Violations
* Institutional Review Boards
* Quality Assurance Activities/Study Auditing/FDA Inspections
* Investigational

Related Books: "Good Clinical Practice"


Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 2, Guidance


Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic:
* FDA Overview and Orientation
* Introduction to GCP
* Part I: General
* Part II: Institutional Review Boards (IRBs) and Informed Consent
* Part III: Drug

Clinical Research Coordinator Handbook, Fourth Edition


"This extremely useful title is written for anyone planning to implement clinical trials at an institution. ... the author has carefully detailed the types of forms, study records, and case report forms. ... A powerful appendix and glossary of rele

A Learner's Guide to Good Practices in Clinical Research


A basic guide about Global Regulatory and Quality environment as it relates to Medical Device/ Biotech/Pharmaceuticals. Strongly recommended for those who are entering the field to get acquainted with historical origin, common terms used as well as g

Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference


FDA Regulations and Associated Guidance Documents: - Part 11 Electronic Records; Electronic Signatures - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medica

The Indispensable Guide to Good Laboratory Practice ( GLP )


Familiarity with Good Laboratory Practice (GLP) is a necessity for those working in or aspiring to work in biotech, pharma, and even academic research, where partnerships with industry require ever greater awareness of drug development regulations. T

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