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ICH & INDIAN GCP PROTOCOL by RAHUL challarahul77@gmail.com
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
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
Ich & indian

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Ich & indian

  • 1. ICH & INDIAN GCP PROTOCOL by RAHUL challarahul77@gmail.com
  • 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