Principles of Good Clinical Practice

Online Shop | Pharmaceutical Press | Regulatory Works |  Principles of Good Clinical Practice

Principles of Good Clinical Practice

Free UK delivery on Principles of Good Clinical Practice

In Paperback Format
Principles of Good Clinical Practice

£42.74
 RRP: £44.99
You save £2.25 (5.0%)
ISBN
9780853697909
Author
Michael J McGraw, Adam N George, Shawn P Shearn, Rigel L Hall and Thomas F Haws Jr (eds)
Published by
Pharmaceutical Press
Publication Date
July 2010
Format
Paperback
Extent
272 pages
Dimensions
256 x 234 mm

Principles of Good Clinical Practice is a one-stop source for guidance and rules for proper conduct of clinical trials. The book also provides a historical perspective of the clinical research landscape.

Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights.

This book describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes:
  • informed consent
  • investigator and sponsor responsibilities
  • site monitoring
  • institutional review boards and independent ethics committees
  • clinical trial registration and reporting
  • quality assurance
  • future implications for good clinical practices.

Principles of Good Clinical Practice is a definitive text for clinical development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries. 
  1. Introduction to Good Clinical Practice
  2. Regulatory Requirements
  3. Informed consent
  4. Investigator responsibilities
  5. Sponsor responsibilities
  6. Clinical Trial Design
  7. Site monitoring
  8. Institutional Review Boards and Independent Ethics Committees
  9. Pharmacovigilance
  10. Clinical trial registration and reporting
  11. Quality assurance
  12. Future Implications of Good Clinical Practice

Download Sample Chapter

Online Shop | Pharmaceutical Press | Regulatory Works |  Principles of Good Clinical Practice

Civil Service Yearbook
The new Civil Service Yearbook 53rd Edition - Pre-order now.
Civil Service Yearbook 52nd Edition available now
Buy The Civil Service Yearbook
IMDG Code 2016 Edition
The new IMDG Code is in stock now.
IMDG Code 2016 available now
Buy The IMDG code
New Products

The Report of the Iraq Inquiry

20 Years of the WTO: A Retrospective

European Pharmacopoeia 9th Edition Book Subscription 2017 (9.0, 9.1 and 9.2)

Boxed set of WTO statistical titles 2015

Services Profiles 2015

World Tariff Profiles 2015

Trade Profiles 2015

Bookmark us via QR code
Worldwide Delivery
Secure Payment
Secure Payment
New Products

Civil Service Yearbook 53rd Edition 2016/17 Online Access

Civil Service Yearbook 53rd Edition 2016/17 Online Access

£80.00 (Excl VAT)

find out more

UN ADR 2017 (Books) Two Volume Set

IATA Dangerous Goods Regulations (DGR) 59th Edition 2018 (Regular Bound)

HSE Approved Codes of Practice - Six Pack (6 Pack) Pack of 6 Books

Civil Service Yearbook 53rd Edition 2016/17

IMDG Code 2014 Edition (inc Amdt 37-14) Book (2 vols)