|
|
Currently, there is scarce evidence on presence of ASCVD risk factors and established ASCVD and status of glycemic control in Indian T2DM patients. Thus in lieu of the above, this retrospective, cross-sectional multicenter study is planned to assess the status of glycemic control in T2DM patients in India in presence of ASCVD risk factors and/or established ASCVD. We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents). We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory investigations are available for the preceding 3 months. We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF. In alignment with good clinical research practices, an independent Contract Research Organization (CRO) will monitor this study and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records. The study is approved by independent ethics committee. If you agree to participate in the said study, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records. |
|
Yours truly, Sun Pharma Laboratories Limited Sun House, 201/B1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063 |