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Book 12:  Selected Regulations/Guidance on GCP in India

Book 12: Selected Regulations/Guidance on GCP in India

$ 15.95

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This spiral-bound, 5" x 7.5" book is a compilation of regulations and guidelines governing the conduct of clinical research in India.  It includes such topics as:

• Good Clinical Practice/ Protection of Human Subjects
• Monitoring and Reporting Adverse Events
• Role of foreign sponsors

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
• US-based staff conducting clinical research in India

What's the Price?
• 1-249 copies:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

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

• Declaration of Helsinki

• India Government, Drug and Cosmetics Rules of 1945
 
      • Preliminary Rules (Rules 1 & 2)
       • Rules on the Import or Manufacture of New Drugs for
         Clinical Trials or Marketing (Rule 122-A, B, D, DA, DAA, DAB,
         DAC, DB, DC, DD and E) plus Form 44 (Revised 2015)
                        
• Guideline for Good Clinical Practices for Clinical Research
   in India

• Schedule Y of the Drug and Cosmetics Rules of 1945:
     Requirements and Guidelines for Permission to Import
     and/or Manufacture New Drugs for Sale or to Undertake
     Clinical Trials (REVISED 2015)

Click here to see an enlarged pdf cover