Author Topic: FORM 1572 and undertaking by the investigator  (Read 5240 times)

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Offline pavi777

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Dear friends,  :) :)

For DCGI Submission (Regulatory) is both form 1572 and Undertaking by the investigator according to schedule Y is requried?

If it is required  then can u elaborate the difference between 1572 and Underatking by the investigator?

I was under the impression tat form 1572 was FDA Version of undertaking by the investigator. Please let me know whether i was right.  :-\

Regards

Dr Pavidhar G

Offline nikita

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Re: FORM 1572 and undertaking by the investigator
« Reply #1 on: Tue, 23 Dec 2008 »
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yes u r rite
Keep the spirits high

Regards
Nikita :-)

Offline __LENITH__

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Re: FORM 1572 and undertaking by the investigator
« Reply #2 on: Mon, 24 May 2010 »
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In better words.. IU is indian version of 1572.
If ethics are poor at the top, that behavior is copied down through the organization

Offline veeru0585

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Re: FORM 1572 and undertaking by the investigator
« Reply #3 on: Wed, 26 May 2010 »
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Hi Pavi,

FORM-1572:
It is a Federal format.The 1572 is a federal form and is the statement of the investigator that he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting. It is available at http://www.fda.gov.

IU-Schedule-Y:
It is the Indian format .Appendix VII of Schedule-Y gives the format for the Letter of Undertaking The Letter Of Undertaking is similar to the FDA 1572.

Both the form-1572 and IU are designed for their country specific.

hope it helps...

veera




HaPpY NeW YeAr 2013

Offline shodh

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Re: FORM 1572 and undertaking by the investigator
« Reply #4 on: Fri, 4 Jun 2010 »
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Do youhave to provide the central lab details in UYndertaking to DCGI and do you need to submit the original OR photocopy of the undertaking is acceptable by DCGI? :)

Offline __LENITH__

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Re: FORM 1572 and undertaking by the investigator
« Reply #5 on: Fri, 4 Jun 2010 »
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Yes We need to provide name & address of Central Lab in IU as in 1572.

Offline msanjay

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Re: FORM 1572 and undertaking by the investigator
« Reply #6 on: Wed, 18 Aug 2010 »
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Form 1572 states that PI or their family has no financial interest or equities on drug/product.
No financial matters influencing him/her to participate in the trial; whereas Investigator Undertaking is a letter that should submit to Regulatory stating that his/her willingness/interested to do the study. I hope u get the difference

Offline shirley@ATC

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Re: FORM 1572 and undertaking by the investigator
« Reply #7 on: Thu, 19 Aug 2010 »
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An FDA form 1572 also known as "the statement of investigator" outlines the responsibilities of the PI and is required for FDA drug development.  This document is considered an attestation (legal agreement) between the PI and the FDA. Other sub I are listed but are not required to sign. Most countries have thier own version of this as well but if you are working with the FDA they will require the form 1572.  The Sponsor submits this will study documents and an FDA form 1571 which is simply a numbered submission cover letter to the FDA. I hope this is helpful.
Shirley

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