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456443319-Cover-Letter-for-MREC-Approval

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FARMASI PESAKIT LUAR
KLINIK KESIHATAN SIMPANG RENGGAM,
JALAN RAMBUTAN, SIMIPANG RENGGAM,
KLUANG,
86200 KLUANG,
JOHOR
TEL: 07-7863333
Date
: 16 January 2020
Chairman
Medical Research and Ethics Committe
Ministry of Health, Malaysia
Dear Sir,
PRESCRIBING PATTERN OF STATINS FOR PRIMARY PREVENTION OF
CARDIOVASCULAR DISEASES IN TYPE 2 DIABETES MELLITUS PATIENTS: A
RETROSPECTIVE CROSS-SECTIONAL STUDY IN JOHOR PRIMARY SETTINGS
With reference to the above matter, I would like to ask for MREC approval and expedite review of the
study.
2.
For your information, we are currently running a study as titled above. This is a multicenter,
retrospective cross-sectional observational study patients with Type 2 diabetes mellitus in Malaysia.
Our objective is to evaluate the prescribing pattern of statin as primary or secondary prevention of
CVD in T2DM patients at Johor. The study population consist of newly diagnosed type 2 diabetes
patient aged between 40-75 years old, receiving treatment at any time from 1st January 2019 to 31st
March 2019, involving 7 primary health care settings in PKD Kluang, Johor (Klinik Kesihatan
Simpang Renggam, Klinik Kesihatan Mengkibol, Klinik Kesihatan Renggam, Klinik Kesihatan Ulu
Belitong, Klinik Kesihatan Kahang Timur, Klinik Kesihatan Layang Layang, Klinik Kesihatan Paloh
and Klinik Kesihatan Kahang Batu 22). Firstly, anonymized data will be extracted from outpatient
diabetic registration record and all the laboratory information regarding patient will be collected from
individuals, patients’ medical records, and electronic data from Pharmacy Information System (PHIS).
As this was done anonymously, informed consent was not required by the ethics review board. This
study is expected to carry out from December 2019 until October 2020.
3.
This study will be carry out by two pharmacist, MUHAMMAD FAZRY BIN HAMIS(UF41)
and CHONG MEN YEE(UF44). We would like to apply for MREC approval to carry on this
research. We also request to expedite review on our study because this study does not involve any
biological specimen as the data will be retrieved from the patient’s record and not directly from the
patients themselves. These data will be strictly used for study purposes and no identification data of
the patient will be used.
3.
Your approval is highly appreciated and we thank you in advance.
Thank you.
Yours sincerely,
(CHONG MEN YEE)
Principal Investigator
Klinik Kesihatan Simpang Renggam,
Kluang Johor.
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