Original Image
click to view more

Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Docum

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

$37.31

List Price: $46.99
Save: $9.68 (20%)
add to favourite
  • In Stock - Ship in 24 hours with Free Online tracking.
  • FREE DELIVERY by Friday, May 16, 2025
  • 24/24 Online
  • Yes High Speed
  • Yes Protection
Tell-A-Friend
Last update:

Description

Topics 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 Drug Accountability, Administration, and Labeling

Last updated on

Product Details

  • PharmaLogika Brand
  • Aug 26, 2010 Pub Date:
  • 9780982147672 ISBN-13:
  • 0982147678 ISBN-10:
  • English Language
  • 9 in * 1.6 in * 6 in Dimensions:
  • 2 lb Weight: