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····8 POONA MEDICAL RESEARCH FOUNDATION40, SASSOON ROAD, PUNE - 411001. Tel.: 020 - 26163391 Fax: 020 - 26164529

To,Dr. RSWadiaConsultant NeurologistRuby Hall Oinic40, Sassoon RoadPune- 411001

Date: 30 Oct 2012

Reference /I A Prospective, longitudinal, case control observation study ofcerebral venous sinus thrombosis in western Maharashtra India. Riskfactors clinical presentations and complications."Institutional Ethics Committee approval for the conduct of the abovementioned study.

Subject

Dear Dr. Wadia,

We have received 12 copies of the Following documents:

SerNo Documents Version01. Protocol Version 1.0 dated 14thJanuary 201202. English Informed Consent Form Version 1.0 dated 14thJanuary 201203. Marathi Informed Consent Form Version 1.0 dated 3rd August 201204. Hindi Informed Consent Form Version 1.0 dated 3rd August 201205. Marathi & Hindi ICF Back Translation -06. Translation Certificate Dated 7thAugust 201207. Back-Translation Certificate Dated 16thAugust 201208 Investigator Undertaking(Induding CV) -

At the Ethics Committee meeting held on 18thOct 2012 at 09.45 am your reference letter andabove documents were examined and discussed. After due consideration the committee hasdecided to approve the conduct of the above mentioned study under your direction atGrant Medical Foundation-Ruby Hall Clinic, 40, Sassoon Road, Pune-411001.

The following members who attended the meeting at which your proposal was discussed arelisted below.

(Scientific! AffiliationSr. Gender withNo. Name of the Member Designation

(MjF) Non- Institutionscientific) (YfN)01. Mr. B P Shaligram Chairperson M Non-scientific N

02. Dr. D.N. BhaleraoMedical

M Scientific yAdministrator

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POONA MEDICAL RESEARCH FOUNDATION40, SASSOON ROAD, PUNE - 411 001. Tel.: 020 - 26163391 Fax: 020 - 26164529

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03. Dr. R.B. Gulati Cardiologist M Scientific y

04. Dr. R. S. Wadia Neurologist M Scientific y

05. Dr. S.G. Deshpande Surgeon M Scientific y

06. Dr. cr. Bajpayee Neurosurgeon M Scientific Y

07, Dr. Prachee Sathe Intensivist F Scientific Y

08. Mrs. M. lCulkarrci Advocate F Non-scientific y

09. Mrs. M. S. Deshpande Social Worker F Non-scientific N

10. Dr. Sohini Arora Microbiologist F Scientific y

11. Mr.SPMehta LayPerson M Non-scientific N

12.Mrs. Kalyani C Member

F Non-scientific YChavan Secretary

We confirm that though Dr. R S Wadia is a member of the Study team, he did not vote at thismeeting.

It is to be noted that neither you nor any of your proposed study team members were presentduring the decision making procedures of EC.

Please note that the Committee is constituted as per ICH-GCP, Schedule Y, and ICMRguidelines.

The Institutional Ethics Committee expects to be informed about the following -• Progress of the study on annual basis• Any Serious Adverse Event occurring in the course of the study• Any changes in the protocol, patient information/ informed consent form and other

critical study related documents• Any protocol deviations• Copy of the final report

SinC~

Mrs. Kalyani ChavanMember SecretaryInstitutional Ethics Committee

MRS. KALYANI C. CHAVANMEMBER SECRETARYETHICS COMMITTEE

POONA MEDICAL RESEARCH FOUNDATION40, ~;A,SSOON ROAD.

PUNF-411 001,

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