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Cover Letter - PD Log Submission January - Oct 2014 - 1245.25 - 62002
Cover Letter - PD Log Submission January - Oct 2014 - 1245.25 - 62002
No: XXX
Kepada YTH:
Prof. Dr. dr. Rianto Setiabudi, SpFK
Ketua Komite Etik Fakultas Kedokteran Universitas Indonesia
Jalan Salemba Raya no. 6
Jakarta, 10430 Indonesia.
Protocol Number & Study Title:
BI10773
A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular
safety study of BI 10773 (10mg and 25mg administered orally once daily) compared to usual
care in type 2 diabetes mellitus patients with increased cardiovascular risk
Re: Submissi Protocol Deviation log January 2014-October 2014
Dengan Hormat,
Mohon melihat terlampir untuk protocol deviation log berdasarkan monitoring visit yang telah
dilakukan dari January 2014-October 2014.
Terima kasih atas perhatiannya jika ada pertanyaan mengenai ini mohon menghubungi saya.
(_____________________)
dr. Dante Saksono Harbuwono, SpPD-KEMD, PhD.
Principal Investigator
Signature:
Date: