To,The Chairperson,Institutional Ethics Committee (Human Research*/ Animal Research *),L.T.M.M.C. & L.T.M.G.H., Sion, Mumbai-400 022.Subject : Submission of Clinical Study Documents for sponsored* / Not sponsored* for your review and approval.
Sir/Madam,I request you to kindly accept my application for the project Titled “< >” which is multinational* / multi centric */ unicentric *study, so as to enable me to conduct the referenced research project at Lokmanya Tilak Municipal Medical College & General Hospital, Sion, Mumbai, if granted permission by the Institution Ethics Committee. I will be responsible towards the co investigators for this project.
The total number of patients that is proposed to be enrolled is “< >” over a period of “ < >” which will be feasible at the Lokmanya Tilak Municipal Medical College & General Hospital, Sion, Mumbai in the above period.
( If Multicentric/ Multinational study then please specify as below)*
The total number of patients planned to be enrolled for all the centres are “< >” and for the centres In India are “< >”
The study is not sponsored / Sponsored *
( If Sponsored please specify as below)*
The study is Sponsored by “< >” located at “< >” and will be represented by “< >”. The sponsorer is a Pharmaceutical/Biotech Company/ Contract Research Organization (CRO)/ ICMR/ Other – “<please specify>”
Please find enclosed herein following documents for your review and approval.
I would be happy to offer any other information or clarification as may be required by you
Thanking you.
Dr. “< > “
“<Designation>”
Dept. of “< >”
Mobile No. “< >”
L.T.M.Medical College & L.T.M.G. Hospital,
Sion, Mumbai 400 022.
- * Please select and type the correct option
“< >” Please provide required information