Author Topic: EC approval of Investigator undertaking  (Read 3139 times)

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Offline Parthiban

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EC approval of Investigator undertaking
« on: Thu, 29 Dec 2011 »
Dear Friends, My question is .... Do we have to submit the Investigator Undertaking as per our DCGI requirements to Ethics committee for thier approval or not....


Offline simply_ingenious

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Re: EC approval of Investigator undertaking
« Reply #1 on: Thu, 29 Dec 2011 »
Dear Prathiban,

Yes, we have to submit it.

Thanks,
Ingenious

Offline Dr.Gunasakaran

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Re: EC approval of Investigator undertaking
« Reply #2 on: Thu, 29 Dec 2011 »
Dear Mr.Parthiban,

We need to submit Investigator Undertaking to the Ethics committee.

Regards,
Dr.S.Gunasakaran, MD
Head-Clinical Research & Medical Affairs, Azidus Laboratories Ltd, CRO
Disclaimer: All the responses and the postings in this Forum are my personal views and opinion. It does not represent/reflect my company strategies and polices on the same.

Offline kkactimus

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Re: EC approval of Investigator undertaking
« Reply #3 on: Thu, 29 Dec 2011 »
Dear Mr.Parthiban,









































Yes the Investigator Undertaking shall be submitted to Ehics Commitee for review as per Schedule Y.






































Regards,















































KK









































Offline Parthiban

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Re: EC approval of Investigator undertaking
« Reply #4 on: Tue, 3 Jan 2012 »
Thank you friends

Offline Parthiban

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Re: EC approval of form 1572 and 3455
« Reply #5 on: Wed, 4 Jan 2012 »
Dear Frieds,

As you all told that we have to get the approvals for Investigators undertaking as per Schedule Y from Ethics commitee but if this is the case then, do we have to get the same approval for FDA forms 1572 and 3455 which is filed for the same reason.......kindly clarify and share your views........

Offline kkactimus

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Re: EC approval of Investigator undertaking
« Reply #6 on: Fri, 6 Jan 2012 »
Dear Mr.Parthiban, As it is specified in the Schedule Y we need submit the Investigator Undertaking for EC review but is is not manadatory for Form 1572 or Form 3455 to be submitted for EC because they are specified for US FDA IND Submissions and not for Indian submissions. As we are conducting the studies in India we need to abide by the law of land first and then we can follow or implement the other regulatory guidelines.
More views welcome.

























Regards















































KK
 






















Offline simply_ingenious

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Re: EC approval of Investigator undertaking
« Reply #7 on: Wed, 11 Jan 2012 »
Hello,

If the study is not submitted to US FDA, then we don't have to get 1572.
If the study is limiting to India only then PI undertaking needs to signed.

This is also true for vice versa.

Regards,
Ingenious.

Offline TamikoAverett

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Re: EC approval of Investigator undertaking
« Reply #8 on: Mon, 18 Apr 2016 »
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