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To,
Mr. M. Sundarrajan
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 Dear Mr. M. Sundarrajan
Subject : In-Practice Usage and Performance (IPUP) Study of ROLES
In response to your letter, IPUP/ROLES/Stanlife /April 2023 dated 20th April, 2023, I agree to participate in the study as outlined by you.
I understand that:
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You will provide me with a copy of the study plan, CRF and full prescribing information ROLES.
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ROLES will be prescribed and purchased as in my routine practice.
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The patients’ identity will not be disclosed in the CRF.
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I have to report serious adverse events (SAE), if any, immediately to your monitor or to you in the AE reporting form.
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You will provide the assistance of a monitor to verify the information in the CRF with that in the patients’ case papers and reports.
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You will pay me by cheque a fee of Rs. 2000 (Rs Two 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.
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