
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
• 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
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