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~ ~~ J-J'aJCDC<? Jehangir Clinical Development Centre{IRB)~ ~ CLINICAL PAECISION ~ Jehangir Hospital Premises, 32 Sassoon Road, Pune - 1 Tel.:+91-20-67268821 /67268804 Fax: 26059319-

Date: 10th Nov 2012

To,

Dr. NasH Ichaporia

Hirabai Cowasji Jehangir Medical Research Institute.

Jehangir Hospital,

32, Sassoon Rd,

Pune- 411001

Study Protocol: A Prospective, Longitudinal, Case Control, Observational Study of Cerebral VenousSinus Thrombosis in Western Maharashtra, India. Risk Factors, Clinical Presentations and Complications.

Sub: Approval of study documents.

Dear Dr NasH Ichaporia,

At the Institutional Review Board meeting held on io" Nov 2012, the documents mentioned below wereexamined and discussed. After thorough consideration, the Committee has decided to approve thefollowing study related documents.

Sr. No. Documents Version1 Protocol Version 1.0, Dated 14to January, 20122 English Informed Consent Form Version 1.0 Dated 14th January, 20123 Marathi Informed Consent Form Version l.0 Dated 3fd August, 20124 Hindi Informed Consent Form Version 1.0 Dated 3rd August 20125 Marathi and Hindi ICF Back Translations -6 Translation Certificate Dated 7tJ1August 20127 Back-Translation Certificate Dated 16111August 20128 Investigator Undertaking -9 Updated CV and MRC of the Investigator -

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The members who attended the meeting held on 1001 Nov 2012, at Conference Hall, JCDC between11.00am to 1.30 pm where your proposal was discussed are as follows:

LIST OF MEMBERS WHO ATTENDED THE MEETING

AFFILIATIONWITH

PRIMARY INSTITUTIONSCIENTIFIC OR (S) (YESINO; IFNONSCIENTIFIC YES, WHICH

MEMBER NAME HIGHEST DEGREES EARNED SEX SPECIALTY ONE(S))

Ph.D.Dr Ravindra Ghooi Medicine,M.Sc(Pharmacology),B.Sc M Scientific No

Dr Pratibha Naik MBBS/ DAlClinical Pharmacologist F Scientific No

Dr. Mrs. Uma P. Divate Consultant Physician(M.D) F Scientific Yes

Mr. C.Y. Joshi B.Com,B.A M Non- Scientific No

Mrs. Vrinda Pusalkar Social Worker, B.A, M.S.W F Non- Scientific No

Mrs. Stella Mendes M.A, L.L.B F Non- Scientific No

M.B.B.S, MHM, M.Phil,Dr. Ujjwal Rao DMLE(PhD) M Scientific No

We approve the trial to be conducted in its presented form (Subject to submission of final CTA)

The Institutional Review Board also determines that the DCGI approval is not applicable for thisstudy.

Jehangir Clinical Development Centre Institutional Review Board expects to be informed about theprogress of the study, any SAE occurring in the course of the study, any changes in the protocol andpatient information/informed consent and asks to be provided a copy of the fmal report.

We confirm that Dr Mrs. U. P. Divate did not vote on the proposal for this study.

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We hereby confirm that Jehangir Clinical Development Centre Institutional Review Board is organizedand operates as per GCP and applicable regulations.

This approval is valid till 9th Nov 2013.

Yours Sincerely, ~

Signature: \1 ~

~Name : Mrs. Vrinda Pusalkar

IRB Vice-Chairperson

Jehangir Clinical Development Centre Institutional Review Board

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