|
To,
Mr Ambrish Sahai
Sun Pharmaceutical Industries Ltd.
Sun House CTS No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai - 400 063; Tel: + 91 22 4324 1234/4324
Dear Mr Ambrish Sahai,
Subject: IPUP Study of Cepodem
In response to your letter, IPUP/Cepodem/GP/Pharma care/April 2023, Dated 1st April 2023, I agree to participate in the study as outlined by you. I understand that:
-
You will provide me with a copy of CRF and full prescribing information on Cepodem & protocol of the study.
-
Cepodem will be prescribed and purchased as in my routine practice.
-
The patients’ identity will not be disclosed in the CRF.
-
No prospective data will be collected/captured in this study.
-
I have to report serious adverse events (SAE), if any, immediately to your monitor or to you in the AE reporting form.
-
You will provide the assistance of a monitor to collect the CRF’s.
-
You will pay me by cheque a fee of Rs. 5000 (Rs. Five thousand only) per patient, and accordingly, on receiving the completed CRFs, of these - patients’, as a compensation for the extra time spent in record keeping. The cheque for fee may be drawn in favor of
“…………………………………………………………………………………………………………………………………………………………..”
My personal details are given below for accuracy of your records.
|