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A Guide for Clinical Research Professionals

ByInternational Biopharmaceutical Association

Usually printed in 3 - 5 business days
A Guide for Clinical Research Professionals covers the following topics: Overview of the Pharmaceutical Industry, Drug Discovery and Drug Development , Pre-clinical studies, New Therapeutic Product - Regulatory Process Overview, Clinical trials - Fundamental elements, Ethical issues in Clinical research, International Conference on Harmonization and Good Clinical Practice, Institutional Review Board / Independent Ethic Committee (IRB/IET): roles and responsibilities, Informed Consent Process, Overview of Some Clinical Trial Essential Documents, Data Collection in Clinical Trials, Investigator: Roles and Responsibilities. Investigator's Study File, Source Documents & Source Documents Verification (SDV), Clinical Data Validation Process & Query Management, Medical Data Coding & SAE Reconciliation, Statistical issues in clinical trials, Sponsor Definition, Sponsor-Company Responsibilities, Clinical Research Organizations, Clinical Research Associate (CRA)/Clinical Monitor and other issues.

Details

Publication Date
May 5, 2012
Language
English
ISBN
9781105728709
Category
Science & Medicine
Copyright
All Rights Reserved - Standard Copyright License
Contributors
By (author): International Biopharmaceutical Association

Specifications

Pages
266
Binding
Paperback
Interior Color
Black & White
Dimensions
US Trade (6 x 9 in / 152 x 229 mm)

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