Topic: Payment to trial subject (Read 211 times)

Nisha_r · « **on:** February 08, 2010, 05:19 PM »

Hi
please clear a doubt

When we look into the requirements for content of ICD, E6 specifies about anticipated porated payment if ay
In case of a clinical trial, for an in patient if we provide some amount of money per day for stay in hospital, do we need to cover it in ICD?
what about the amount we gave for allowance for each visit.( both is been covered in the CTA with investigator but not in ICD). Please suggest on this

Dr.Yashodha Reddy · « **Reply #1 on:** February 09, 2010, 04:14 AM »

Hi Nisha,

Payment to the subjects for their participation in the study should be described even in the Informed Consent Form. Whether it is only travel expenses or some amount for their stay in the hospital (example like in PK studies or BA/BE studies - payment to subjects for their stay in the hospital etc). However, details of payment to the subjects / subjects compensation is covered in the CTA; but still, it should be described in the ICD for subjects reference.

Also refer the following link:

http://clinicalresearchforum.com/informed-consent/what-is-anticipated-prorated-payment/msg14479/#msg14479

mojjadavs · « **Reply #2 on:** April 07, 2010, 12:44 PM »

Hi Nisha,

As Dr.Asodha said, Payment must be mentioned in the ICF as we are calculating the study compensatation amount based on the blood drawn from the subject. And it need to be notified to IEC also.

Vamsy

Author Topic: Payment to trial subject (Read 211 times)

Nisha_r

Payment to trial subject

Dr.Yashodha Reddy

Re: Payment to trial subject

mojjadavs

Re: Payment to trial subject

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