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change in statistical and bioanalytical site a form IEC appr [Regulatives / Guidelines]

posted by raghu – India, 2013-05-28 10:58 (4775 d 06:23 ago) – Posting: # 10671
Views: 2,189

Dear BalaVivekanand,

Modify the Protocol or Amend the Protocol with proper version change.
Submit the Protocol/amendment to IEC concerned new clinical site
Notify the EC approved protocol and its amendments to the DCGI on reason for site change and changes made in the updated protocol etc

Regards
Raghavender

Complete thread:

change in statistical and bioanalytical site a form IEC appr vivekanand 2013-05-25 06:16
- change in statistical and bioanalytical site a form IEC apprraghu 2013-05-28 08:58
  - change in statistical and bioanalytical site a form IEC appr sarada06884 2013-05-29 08:39

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