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Ethical Committee Approval

The Institutional Ethical Committee of the Benchmark Medical Trust has approved a clinical study titled "A Prospective Study on Congenital Anomalies and their Genetic Predisposition" conducted by Dr. M. Pradeep Kumar as the Principal Investigator. The committee reviewed and approved the research proposal, informed consent forms, letters of agreement for project funding and compensation. The committee expects to be updated on the study's progress and be notified of any protocol modifications, adverse events or final results. Approval is granted provided the study follows ICH-GCP principles, Schedule Y and ICMR guidelines.

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38 views

Ethical Committee Approval

The Institutional Ethical Committee of the Benchmark Medical Trust has approved a clinical study titled "A Prospective Study on Congenital Anomalies and their Genetic Predisposition" conducted by Dr. M. Pradeep Kumar as the Principal Investigator. The committee reviewed and approved the research proposal, informed consent forms, letters of agreement for project funding and compensation. The committee expects to be updated on the study's progress and be notified of any protocol modifications, adverse events or final results. Approval is granted provided the study follows ICH-GCP principles, Schedule Y and ICMR guidelines.

Uploaded by

ganeshkumar jayakrishnan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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BENCHMARK MEDICAL TRUST

262, Bypass Road, Unjampatti Village,


Annanji post, Theni - 625 531
Theni District. Phone: 04546-255233
_____________________________________________________________________________________

ETHICS COMMITTEE APPROVAL LETTER


_____________________________________________________________________________________

Ref. No. : BMT/IEC/2022/07/02 Date: 28.07.2022

To

Dr. M. Pradeep Kumar, (Principal Investigator)

Clinical Geneticist,

GeneOmm Medical Centre,

Uppilipalayam, Coimbatore - 641015

TamilNadu, India

Subject: Approval of the clinical study – “A Prospective Study on Congenital Anomalies and their Genetic
Predisposition” by the Institutional Ethical Committee

Dear Dr. M. Pradeep Kumar,

The Benchmark Medical Trust, Institutional Ethical Committee (BMT, IEC) has reviewed and discussed

your application to conduct the above mentioned clinical research study, with yourself as the Principal

Investigator and Dr. S. Jeevithan as Co-Investigator.

The following list of all documents submitted to IEC that have been verified, reviewed and approved:

Serial No. Name of the Documents Version No. & Date


1. Verified Research Project Proposal (Version 1, Document 1) 25.7.22
2. Relevant Informed Consent Form(s) (Version 1, Document 2)
3. Letter of Agreement for Project Funding 25.07.2022
4. Letter of Agreement for Compensation 25.07.2022
BENCHMARK MEDICAL TRUST
262, Bypass Road, Unjampatti Village,
Annanji post, Theni - 625 531
Theni District. Phone: 04546-255233
_______________________________________________________________________________________

The following members of the Ethical committee were present at the virtual meeting held on 27.07.2022

Affiliation to
S.No Name Designation Qualification Gender Attendance
Institute
Dr. Ganeshkumar
1 Chairman MS (Ophthal) Male Yes No
Jayakrishnan
Dr. Ramasamy MBBS,
2 Secretary Male No Yes
Valliappan PGDH.SC
Joint MD, DM
3 Dr. S. Krupashankar Male Yes No
Secretary (Med. Onco)
Social
4 Mr. S. Nandagopal B. Tech Male Yes No
Scientist
5 Mr. C.R. Jaimurugan Legal advisor B.A, B.L Male Yes Yes
6 Dr. R. Preethi Member MDRD Female No Yes
7 Mr. R. Kannan Lay person Male Yes No

We approve the research study to be conducted in the presented form.

None of the Principal Investigator and co-investigators participating in this study took part in the decision
making and voting procedure of the approval process for this study.

This Ethical committee is working in accordance to ICH-GCP principles, Schedule Y and ICMR guidelines and
other applicable statutory regulations.

The Institutional Ethical Committee expects to be informed about the progress of the study and provided with
a copy of the final report.

The Principal Investigator is expected to notify the IEC of any modification/revision of the approved study
protocol, patient data, informed consent and of any serious adverse events (SAE) occurring during the course
of the study, within a week. The committee reserves the right to revoke/terminate approval status if needed.

Yours Sincerely,

Dr. S. Krupashankar Dr. J. Ganeshkumar

Joint Secretary Chairman

BMT IEC BMT IEC

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