,

POONA

Reference: A0081194 entitled "A RANDOMIZED, DOUBLE-BLIND. PLACEBO-CONTROLLED, PARALLEL GROUP. MULTI-CENTER TR IAL OF PREGABALIN CONTROLLED RELEASE FORMULATlON AS ADJUNCTIVE TllERAPY IN AD LTS WITH PARTIAL ON ET SEIZURES - PROTOCOL A0081194"

Subject: Approval of the study documents and the conduct of the referenced study at Poona Hospital and Research Centre.

Dear Dr. S. Kothari.

With reference to the above subject we write to inform you that the Ethics.committee, Poona Hospital & Research Centre. in its meeting on 2nd July 20 11 at 12.00nool1 reviewed the documents mentioned in your submi sion lell .. dated I Sill Jun 20 I} .

The thics Committee. Poona Hospital & Research Centre, has conducted an ethical review of the documents for the above r ferenced clinical study. The IEC reviewed the following documents & grants its approval:

1. Clinical Protocol Final version dated II Aug 2010.

2. Investigator's brochure vers ion July 2010.

3. Summary of changes in a Revised Investigator brochure.

4. Case Report Form version 20 January 2011

5. Informed Consent Document in English, Hindi and Marathi languages version dated 1 0 January 2011.

6. Subject Dosing Dairies in English and Hindi language version 11 Aug 20 IO.

7. Su~icct Seizure Dairies in English and Hindi Language version 11 Aug 20 IO.

/

Date: 02107/2011

No. TRiMRSIEC/02112011-12/482

To. Dr. Sudhir Kothari Neurol g:y Department Poona Hospital & Research Centre, Pune - 411030.

n, Ii< GUlarolrt Charita" I! QUndllll • ,

HOSPITAL AND RESEARCH C NTRE __~____________

.-----~--------- 27,SAoASHJVPET~ , F'r'NE · II I (l30. PHONES . 9 LO 24~n7()(),. f'l6lJ96000 FA., . 9}.'~o.J!1J3A<1:7 r m"iJ J'IIutif' jp'M ' C<)'n W.I " : WOoV.I pocn, ItnionJ.

ISO 9001 :20D8 C rtmecl HosPital

•

8. Followrng Questionnaire in English and Hindi Language. • Benefit. Satisfaction and Willingness (BSW) To Continue final version

I • Hospital Anxiety and Depression Scale (I-lADS) final version I • Medical Outcomes Study (MOS Sleep) tinal version I • Patient Health Questionnaire (PHQ-8) final version I • Sheehan-Suicidality Tracki ng Scale (Life Time Assessment) final

version I • Sheehan-Suicidality Tracking Scale (Since last visit) final version 1

9. Investigator His Law Information Ictter version dated 21 51 September 20 I 0 ill English.

10. Investigational site Hy's Law Tmining Guide 22 Dec 2010 in English

I J. Patient ID Card

12. Clinical Trial Agreement Template.

13. The Ethics committee has noted that the following method/s of patient aeeru will be used in the tudy:

• Patients visiting this hospital! inst.itute OPD's • Referred patients from primary health care centre! private practitioner '

through verbal communication and discussion • Patient Database

14. The Ethics committee has noted that the maximum number of patients expected to be mndomized rrom this site will be 15.

15. Principal Investigator's current CV.

16. Insurance certificate

17. Copy of Investigator Undertaking

18. Patients travel expense reimbursement at the rate of 1- tor patients within the city and /- for patients out<;ide the city (per visit made to site)

19. It is also noted thl\t the PK Samples would be senl 10 the tollowing central laboratory from Quintiles Technolo 'es (India} Private limited (a1l samples from site will be ent drrectly to Quintiles Technologies (India) Priva£e limited, only PK samples will be forwarded onwards to following lab); Wuxi AppTec 288 Fu Te Zhong Lu WaiGaoQiao Free Trade Zone Shangai, China 20013 I

•

20. Th.e Ethics Committe has noted that the central laboratory will be used for all protocol specified inve 'ligations in the l>1udy and Local laboratory at Ihis institute will be used felT emergency investigations. Central Lab:

• Quintiles Technologies (India) Private limited, Lab Division (QMUM), 30 I· A·2, Leela Business Park, M V Road, Andheri (East), Mumbai 400 059 India. Local Laboratory: Pathology Lab Poona Hospital and Research Centre Poona Hospital and Research entre, 27, Sadashiv Peth, Pune - 411030, Maharashtra. India.

We approve the trial to be conducted in its presented form.

The Ethics Committee, [loona Hospital & Re earch Centre expects to be infomled about the progress of the study. any SAE (Site SAE to be informed within 7 working days) occurring in the course of the study, any changes in the protocol and patient information/informed consent and asks to be provided a copy of the final report.

We hereby confirm that the Ethics Committee, Poona Hospital & Re earoh Cent re is organized and operates as per amended schedule Y (20th Jan 2005), leH G P guidelines and applicable regulations.

The members who aHended the meeting held on 2nd July 201 I at 12.00000n at which your proposal was discussed are as follows:

Name Qualification Designation! Title AffiliatioDs as to the Institution Yes! No

Dr.(Ms.)Neena Luthra MD (Pathology) Chairperson, Ethics Committee

No

Dr.(Ms.)J.Ravindranath MBBS.DHA Director, Poonn Hospital and Research Centre

Ye

Dr. (Ms.) R. Sengupta MBBS Medical Admin istrator, Poona Hospital and Researoh Centre

Ye

Mr.Kiritbhai Shah B.Com.L.L.B Trustee, Poona Hospital & Research Centre (Legal Expert)

Yes

Dr.Dattatreya M.Dhavale M.D. (Psychiatry) Consultant P~Nntrist

Yes

Dr. (Ms.)Divya Patcl M.B. B.S., M.D. (Pathology)

Pathologist Yes

Dr. Ajay Khurana DNB (Medicine) Consultant Physician Yes

Dr. (Ms.) Trupti Mehta B.H.M.S .. P.G.D.H.M.

Mem ber Secretary Y

Dr. V ena Ambekar MBBS, PGDHHM, CCCR

Quality Mana&rcr. Poona Ho.spita l & Research Centre

Yes

Mrs. Rupali Roy M.A.(Sociology) B.Ed

Housewite No

Ms Vaishali Phansalkar B.A., M.S.W Social Worker Yes