Log in
Registerchange 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
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
Complete thread:
- change in statistical and bioanalytical site a form IEC apprvivekanand 2013-05-25 06:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- change in statistical and bioanalytical site a form IEC appr raghu 2013-05-28 08:58
- change in statistical and bioanalytical site a form IEC appr sarada06884 2013-05-29 08:39
- change in statistical and bioanalytical site a form IEC appr raghu 2013-05-28 08:58
Ing. Helmut Schütz