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Registerchange in statistical and bioanalytical site a form IEC appr [Regulatives / Guidelines]
Dear Mr. BalaVivekanand,
1. If the study is yet to be initiated, modify the Protocol or Amend the Protocol with proper version change and get it approved by the Ethics committee. Also notify the EC approved protocol and its amendments to the DCGI citing the reason for site change and changes made in the updated protocol but on the condition that the site is a DCG(I) approved site. The regulatory body to which this study is to be submitted is to be notified about the change in the facility and the new site has to be approved by the regulatory prior to conduct of the study (regulators like ANVISA, Turkey etc. who give facility based approvals).
If the study is initiated and a phase of the study is partly completed, say the clinical phase then, the Ethics committee and DCG(I) and the regulatory to which this study is to be submitted is to be notified regulators like ANVISA, Turkey etc. who give facility based approvals). The next phase of the study can only be conducted only after the regulatory authorities give approval to the new site (regulators like ANVISA, Turkey etc. who give facility based approvals).
Regards
Srinivas
1. If the study is yet to be initiated, modify the Protocol or Amend the Protocol with proper version change and get it approved by the Ethics committee. Also notify the EC approved protocol and its amendments to the DCGI citing the reason for site change and changes made in the updated protocol but on the condition that the site is a DCG(I) approved site. The regulatory body to which this study is to be submitted is to be notified about the change in the facility and the new site has to be approved by the regulatory prior to conduct of the study (regulators like ANVISA, Turkey etc. who give facility based approvals).
If the study is initiated and a phase of the study is partly completed, say the clinical phase then, the Ethics committee and DCG(I) and the regulatory to which this study is to be submitted is to be notified regulators like ANVISA, Turkey etc. who give facility based approvals). The next phase of the study can only be conducted only after the regulatory authorities give approval to the new site (regulators like ANVISA, Turkey etc. who give facility based approvals).
Regards
Srinivas
Complete thread:
- change in statistical and bioanalytical site a form IEC appr vivekanand 2013-05-25 06:16
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Ing. Helmut Schütz