Bioequivalence and Bioavailability Forum • change in statistical and bioanalytical site a form IEC appr

vivekanand
☆

India,
2013-05-25 08:16
(4778 d 12:50 ago)

Posting: # 10652
Views: 2,573

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

Dear All

In general BA/BE protocol specify the details of Facility address where the study shall be conducted like Clinical site, Statistical sit, Analytical site, Radiological site, Lab Diagnostic site, For which protocol shall be approved from IEC and DCG(I) for T-license and BE-NOc (if required),

If the clinical part of the study couducted in the site mentioned in IEC approved protocol,later this site is shifted to new facility from the existing site (where new facility is approved by DCG(I) and other regulatory bodies if required). Rest of the study part that is Bioanalytical and Statistical part of the BA/BE study conducted in new site. What is the regulatory stand for this?

what are the approvals required.

Regards
BalaVivekanand

raghu ★ India, 2013-05-28 10:58 (4775 d 10:08 ago) @ vivekanand Posting: # 10671 Views: 2,192	change in statistical and bioanalytical site a form IEC appr Post reply
	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

sarada06884
☆

India,
2013-05-29 10:39
(4774 d 10:27 ago)

@ raghu
Posting: # 10681
Views: 2,155

change in statistical and bioanalytical site a form IEC appr

Post reply

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