2. ICH INDIAN
1. General information 1. General information
2. Back ground information 2. Objectives & justification
3. Trial objectives & purpose 3. Ethical consideration
4. Trial design 4. Study design
5. Selection & with drawl of 5. Inclusive, exclusive & with
subjects drawl of subjects
6. Treatment of subjects 6. Handling of product
7. Assessment of efficacy 7. Assessment of efficacy
8. Assessment of safety 8. Assessment of safety
9. Statistics 9. Statistics
10. Direct access to source 10. Data handling &
data/doc management
3. 11. Quality control & 11. Quality control &
assurance assurance
12. Ethics 12. Finance & insurance
13. Data handling & record 13. Publication policy
keeping 14. evaluation
14. Financing & insurance
15. Publication policy
16. supplements
