Covering Letter Format
- Ethics Committee
- Introduction
- Notification
- Instructions for Research Project Submission Document Application
- Sample Project
- Amendments to Protocol / Communications Protocol
- Principal Investigator Change Protocol
- Application Letter for Release of Finances
- Submission Letter for Deposits towards Project
- Submission Letter for Serious Adverse Effects for Research Project
- Research Project & Amendments Processing Fees
- Research Project Document Submission Check List Format
- Acknowledgement Form Format
- Title Page Format
- Joint Undertaking by Principal Investigator and Sponsor Format
- Project Index page Format
- Covering Letter Format
- Project Summary Format
- Research Protocol Application Format
- Project Completion Letter Format
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
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