
Good Clinical Practices
Quality Assurance Systems
LAP Lambert Academic Publishing
Published on 9. February 2012
Book
Paperback/Softback
92 pages
978-3-8465-8921-2 (ISBN)
Description
Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. "Good Clinical Practice (GCP) is defined as a' standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected." "Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible."
More details
Language
English
Place of publication
Germany
Product notice
Paperback (trade)
Unsewn / adhesive bound
Dimensions
Height: 220 mm
Width: 150 mm
Thickness: 7 mm
Weight
155 gr
ISBN-13
978-3-8465-8921-2 (9783846589212)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Persons
Hardik Prajapati, (M.Pharm)is a PG student at A. R. & G. H. Patel College of Pharmacy, Vallabh Vidyanagar. Rajesh K.Patel, M. Pharm, (Ph.D.) is an Asst. Professor at K. J. College of Pharmacy, Vadasma. Bhuvan P. Raval, M.Pharm, PGDPRA, MBA, (Ph. D.), FSAB is an Asst. Professor at K. J. College of Pharmacy, Vadasma.