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To,
Dr. Amey Mane,
Sun Pharma Laboratories Ltd.,
Sun House, Goregaon east,
Mumbai.
Dear Dr. Mane,
Subject : Evaluation of prevalence and current management practices of established ASCVD in
Indian patients with type 2 diabetes mellitus (LEGACY-II)
In response to your letter dated _________, I give my consent to participate in the above captioned
study bearing protocol number SP/CVD/LEGACY-II/RWE-12-2023.
I understand that:
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You will provide me with a copy of the study Protocol and the requisite number of Data Collection
forms (DCFs)
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The DCFs will capture data as defined in the Protocol, including laboratory results as prescribed
and performed in accordance with my routine clinical practice and no fresh laboratory or any
investigations will be conducted for the said study
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The patient’s identity shall not be disclosed in the DCF
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I will ensure to capture all available information accurately and completely in the DCF provided
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I understand and agree to allow an independent Contract Research Organization(CRO) to visit the
study center and compare the information supplied in the DCF to that in medical records
My personal details are given below for accuracy of your records.
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