1

Your cart is empty.

The Most-Trusted Regulations & Guidelines Books on the Market.

Celebrating 15 Years of Excellence.

Now Accepting Pre-orders for 2017 Books

Book 1SP:  SPANISH LANGUAGE 2012 Selected FDA Regulations and ICH Guidelines for Clinical Studies for US Drug Approval

Book 1SP: SPANISH LANGUAGE 2012 Selected FDA Regulations and ICH Guidelines for Clinical Studies for US Drug Approval

$ 19.95

Return to Previous Page

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

 

Table of Contents

• CFR Title 21:  Food and Drugs (Revised as of April 1, 2012)
       Parts  11    Electronic Records/Electronic Signatures
                 50    Protection of Human Subjects
                 54    Financial Disclosure
                 56    Institutional Review Boards
                 312  Investigational New Drug Application

• ICH Guidelines
       E6     Good Clinical Practice

 

Click here to see an enlarged pdf cover