Book 1SP: SPANISH LANGUAGE
2013 Selected FDA Regulations & ICH Guidelines
for Clinical Studies for US Drug Approval

  Description        Contents         Book Cover        How to Order

Description

This spiral-bound, 5" x 7.5" book consists of Latin American Spanish translations of FDA regulations and the ICH Guideline on Good Clinical Practice that govern the conduct of clinical trials for drug research.  It includes such topics as:

• Good Clinical Practice/ Protection of Human Subjects
• IND filing requirements
• Electronic Records and Signatures
• Monitoring and Reporting Adverse Events

Who Uses this Book and How?
• Clinical Research staff, as job aids
• Training departments, as training handouts
• Human Resources, as part of new-employee orientation
• Legal/Regulatory/QA staff, for company-wide distribution

What's the Price?
• 1-249 copies:  $19.95             • 250-499 copies:  $18.95
• 500-749 copies: $17.95          • 750+ copies:  $16.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title