independent ethics committee fogsi€¦ · cv and undertaking of the principal investigator s. no....

Independent Ethics Committee FOGSI

Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11

Telephone Contact Fax Contact

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Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22

Email: [email protected]

To

Mr. Mustafa Pardiwala

GVK Biosciences Pvt. Ltd.

2nd floor, Mumbai International Airport Ltd

Terminal 1B, Domestic Airport

Vile parle, Mumbai 400057, India

The Independent Ethics Committee reviewed and discussed your application to conduct the

bioequivalence study / Clinical Trial entitled “Impact of Counseling on Selecting a Hormonal

Contraceptive Method”

Protocol Title: Impact Of Counseling on Selecting a Hormonal Contraceptive Method

Protocol No.: P08385; Version; 1.0, Dated:25th October 2011

FOGSI EC IEC operates in compliance with guidelines laid down for ERBs by ICH GCP, WHO,ICMR

and CDSCO and declaration of Helsinki and existing laws and regulations and according to which

following submitted Documents are reviewed

1 Study /Clinical Trial Protocol No.: P08385; Version; 1.0, Dated:25th October 2011

2. CV and undertaking of the Principal investigator

S.

No.

Principal

Investigator Site Address

1. Dr. Atul Munshi Munshi Nursing home, 50, Pritam nagar society, Elisbridge,

Ahmadabad 380006

2. Dr.Rupashree

Bhoyar

Ace women's Hospital, Umiya Tower, Central Avenue, Near

Chandrasekhar Azad Sqr. Nagpur-440008




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3. Dr. Rupam Arora A -13, Priadarshin Vihar Laxmi Nagar, New Delhi - 110092

4. Dr. Kiran Desai Dr. Desai's Nursing Home, 1st floor, Apurva Apt., Nehru Park,

Vastrapur, Near Fountain, Ahmedabad-380015

5. Dr. Gayatri

Deshpande

Criticare Hospital, Gulmohar Road, JVPD Scheme, Andheri West,

Mumbai - 400049

6. Dr. Avan Dadina Dr. Avan Clinic, 3, Maheshwar Niketan, 1st floor, Deshmukh Road,

Mumbai 400026

7. Dr. Deepa Singh Ashoka Nursing Home & Hospital, F15/16, Krishna Nagar, Delhi-

110051

8. Dr.Poonam

Gupta Genesis, C-49, Preet Vihar, Delhi 110092

9. Dr. Sunita

Chandra Rajendra Nagar Hospital, 74 Rajendra Nagar, Lucknow-226004

10. Dr.Uma

Sheshagiri

#76 East Park rd; 13th cross, Sampige rd; Malleshwaram; Bangaluru

3

11. Dr.Priti Vyas No.174, S.V Road, 11, Gangavihar Residency, Opposite Dena Bank,

Andheri West, Mumbai, 400058

12. Dr Pallaniappan Shree Rama Chandra Medical College, No. 1, Ramachandra Nagar,

Porar, Chennai-600116

13. Dr. M. Krishna

Kumari

Image Hospital, Ameerpet, Hyderabad-500073

14. Dr. Pushpa

Jaiswal

Sri Ram Memorial Hospital, Near Shalimar Crossing, A- 1030, Indira

Nagar, Lucknow-226016

15. Dr. Priyadarshini Thankam Hospital, West Yakkara, Palakkad - 678 014

16. Dr. Susheela

Rani

Manjushree Speciality Hospital, No. 22/70, St. John's Road,

Bangalore-560042




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17. Dr.Anita Goyal 1/31 Vidyadhar Nagar,Jaipur -302023

18. Dr.Sukumar Barik 68/8 Purna Das Road, Kolkata -700029

19. Dr.Jaiashree

Gajraj

No 3 I Block Mangai Womens Health Exclusive, Opp Way To Tansihq

Jewellery Showroom, 2ND Main Road, Anna Nagar East, Chennai -

600102

20. Dr.Ratnaboli

Chakravorty AE -768 SaltLake, Kolkata 700064

21. Dr.Anita Singh Avantika Hospital, 34/2 Ashirwad Complex, Central Bazar Road,

Ramdaspeth, Nagpur-440010

22. Dr. Uma Ram Seethapathi,Clinic & Hospital,128/241 Royapeetah high

road,Chennai-600014

23. Dr.Mitra Saxena Ashwini Saxena Hospital, Rewari- 123001

24 Dr. Sreekrishna

Patri

Valluvanad Hospital,ottapalm,Aswini Hospital,Ottapalam,Archana

Clinic,Kanniyampuram,Ottaplam

25 Dr.Sonal

Kotadawala 5/b ,Uma park society , bhula bhai park ,Ahemdabad 380022

26 Dr.Jayantha Rath Jail Road, Tinkonia Bagicha, Cuttack

27 Dr.Vidya Bhat Radhakrishna Hospital,Girinagar,Bangalore

28 Dr.Anita Singh Jan Chikitsa Hospital,Mithapur,Patna-1

29 Dr.Fahimida

Banu

Fahmicare Hospital, 37, Tahirvilla, Yosufguda Checkpost, Hyderabad

– 500045

Please find enclosed the following documents that are common for all the sites, for EC

submission:




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1. Appendix II Questionnaire Part B-For participating Women ,Kannada

Version 01 dated 26 December 2011

03 copies

2. Appendix II Questionnaire Part B-For participating Women ,Oriya Version

01 dated 22 March 2012

03 copies

3. Appendix II Questionnaire Part B-For participating Women ,Malayalam


03 copies

4. Appendix II Questionnaire Part B-For participating Women ,Gujarati


03 copies

5. Appendix II Questionnaire Part B-For participating Women ,Telugu Version

01 dated 26 December 2011

03 copies

6 Appendix II Questionnaire Part B-For participating Women ,Urdu Version

01 dated 26 December 2011

03 copies

7. Counseling Sheet for hormone related contraceptives Translated from

English to Marathi 09 February 2012

03 copies

8. Counseling Sheet for hormone related contraceptives Back Translated

from Marathi to English 09 February 2012

03 copies

9. Counseling Sheet for hormone related contraceptives Translated from

English to Telugu 09 February 2012

03 copies

10 Counseling Sheet for hormone related contraceptives Back Translated

from Telugu to English 09 February 2012

03 copies

11 Counseling Sheet for hormone related contraceptives Translated from

English to Tamil 09 February 2012

03 copies


from Tamil to English 09 February 2012

03 copies




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English to Hindi 09 February 2012

03 copies


from Hindi to English 09 February 2012

03 copies


English to Kannada 09 February 2012

03 copies


from Kannada to English 09 February 2012

03 copies


English to Gujarati 09 February 2012

03 copies


from Gujarati to English 09 February 2012

03 copies


English to Bengali 09 February 2012

03 copies


from Bengali to English 09 February 2012

03 copies


from Urdu to English 16 February 2012

03 copies


English to Urdu 16 February 2012

03 copies


from Malyalam to English 10 February 2012

03 copies


English to Malyalam 10 February 2012

03 copies

25 Counseling Sheet for hormone related contraceptives English 25 Oct

2011

03 copies

26 Clinical Trial Agreement: Bi-partite & Tri-partite 03 copies




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Also enclosed please find the following site specific documents for each individual site:

1) Dr. Atul Munshi

1 Copy of the Undertaking of the Investigator 03 copies

2 Copy of the CV of Principal Investigator 03 copies

3 Informed Consent Form-Site Specific ICF(Dr. Atul Munshi):English Version

dated 30 Jan 2012

03 copies

4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 06 Feb

2012

03 copies

5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version

dated 06 Feb 2012

03 copies

6 Informed Consent Form-Site Specific ICF: Gujarati Final Version dated 06 Feb

2012

03 copies

7 Informed Consent Form-Site Specific ICF: Gujarati Back Translation Version

dated 04 Feb 2012

03 copies

8 Informed Consent Form – Site Specific English to Gujarati Version dated 04

Feb 2012

03 copies

9 Informed Consent Form – Site Specific English to Hindi Version dated 04 Feb

2012

03 copies

2) Dr.Rupashree Bhoyar



3 Informed Consent Form-Site Specific ICF(Dr.Rupashree Bhoyar):English

Version dated 23 Jan 2012

03 copies




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4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 25 Jan

2012

03 copies


dated 25 Jan 2012

03 copies

6 Informed Consent Form-Site Specific ICF: Marathi Final Version dated 25 Jan

2012

03 copies

7 Informed Consent Form-Site Specific ICF: Marathi Back Translation Version

dated 25 Jan 2012

03 copies

8 Informed Consent Form – Site Specific English to Hindi Version dated 24th

Jan’ 2012

03 copies

9 Informed Consent Form – Site Specific English to Marathi Version dated 24th

Jan’ 2012

03 copies

3) Dr. Rupam Arora



3 Informed Consent Form-Site Specific ICF(Dr. Rupam Arora):English Version

dated 07 Feb 2012

03 copies


2012

03 copies


dated 08 Feb 2012

03 copies


2012

03 copies

4) Dr. Kiran Desai




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3 Informed Consent Form-Site Specific ICF(Dr.Kiran Desai):English Version

dated 23 Jan 2012

03 copies


2012

03 copies


dated 24 Jan 2012

03 copies

6 Informed Consent Form-Site Specific ICF: Gujarati Final Version dated 24 Jan

2012

03 copies

7 Informed Consent Form-Site Specific ICF:Gujarati Back Translation Version

dated 24 Jan 2012

03 copies

8 Informed Consent Form – Site Specific English to Hindi Version dated 23 Jan

2012

03 copies


Jan 2012

03 copies

5) Dr. Gayatri Deshpande



3 Informed Consent Form-Site Specific ICF(Dr. Gayatri Deshpande):English

Version dated 27 Jan 2012

03 copies


2012

03 copies


dated 28 Jan 2012

03 copies




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2012

03 copies


dated 28 Jan 2012

03 copies


2012

03 copies

9 Informed Consent Form – Site Specific English to Marathi Version dated

27Jan 2012

03 copies

6) Dr. Avan Dadina



3 Informed Consent Form-Site Specific ICF(Dr. Avan Dadina):English Version

dated 27 Jan 2012

03 copies


2012

03 copies


dated 28 Jan 2012

03 copies


2012

03 copies


dated 28 Jan 2012

03 copies


2012

03 copies

9 Informed Consent Form – Site Specific English to Marathi Version dated 27

Jan 2012

03 copies




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7) Dr. Deepa Singh



3 Informed Consent Form-Site Specific ICF(Dr. Deepa Singh):English Version

dated 17 Feb 2012

03 copies


2012

03 copies


dated 18

Feb 2012

03 copies


2012

03 copies

8) Dr.Poonam Gupta



3 Informed Consent Form-Site Specific ICF(Dr.Poonam Gupta):English Version

dated 17 Feb 2012

03 copies


2012

03 copies


dated 18

Feb 2012

03 copies


2012

03 copies




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9) Dr.Sunita Chandra



3 Informed Consent Form-Site Specific ICF(Dr.Sunita Chandra):English Version

dated 06 Feb 2012

03 copies


2012

03 copies


dated 07 Feb 2012

03 copies

6 Informed Consent Form -Site Specific English to Hindi Version dated 06 Feb

2012

03 copies

10) Dr.Uma Sheshagiri



3 Informed Consent Form-Site Specific ICF(Dr. Uma Sheshagiri):English

Version dated 06 Feb 2012

03 copies

4 Informed Consent Form-Site Specific ICF: Kannada Final Version dated 08

Feb 2012

03 copies

5 Informed Consent Form-Site Specific ICF: Kannada Back Translation Version

dated 08 Feb 2012

03 copies

6 Informed Consent Form – Site Specific English to Kannada Version dated 07

Feb 2012

03 copies

11) Dr.Priti Vyas




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3 Informed Consent Form-Site Specific ICF(Dr.Priti Vyas):English Version dated

08 Feb 2012

03 copies


2012

03 copies


dated 09 Feb 2012

03 copies

6 Informed Consent Form-Site Specific ICF: Marathi Final Version dated 09 Feb

2012

03 copies


dated 09 Feb 2012

03 copies


2012

03 copies

9 Informed Consent Form – Site Specific English to Marathi Version dated 08

Feb 2012

03 copies

10 Informed Consent Form-Site Specific ICF: Gujarati Final Version dated 09 Feb

2012

03 copies


dated 09 Feb 2012

03 copies


Feb 2012

03 copies

12) Dr.Pallaniappan






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3 Informed Consent Form-Site Specific ICF(Dr.Pallaniapan):English Version

dated 19 Jan 2012

03 copies

4 Informed Consent Form-Site Specific ICF:Tamil Final Version dated 28 Jan

2012

03 copies

5 Informed Consent Form – Site Specific English to Tamil Version dated 27 Jan

2012

03 copies

6 Informed Consent Form-Site Specific ICF: Tamil Back Translation Version

dated 27 Jan 2012

03 copies

13) Dr. Krishna Kumari Meka



3 Informed Consent Form-Site Specific ICF(Dr.Krishna Kumari):English Version

dated 31 Jan 2012

03 copies


2012

03 copies


dated 01 Feb 2012

03 copies


2012

03 copies

7 Informed Consent Form-Site Specific ICF: Telugu Final Version dated 1 Feb

2012

03 copies

8 Informed Consent Form-Site Specific ICF: Telugu Back Translation Version

dated 25 Oct 2012

03 copies

9 Informed Consent Form – Site Specific English to Telugu Version dated 31

Jan 2012

03 copies




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14) Dr. Pushpa Jaiswal



3 Informed Consent Form-Site Specific ICF(Dr.Pushpa Jaiswal):English Version

dated 06 Feb 2012

03 copies


2012

03 copies


dated 07 Feb 2012

03 copies


2012

03 copies

15) Dr. Priyadarhini



3 Informed Consent Form-Site Specific ICF(Dr.Priyadarshini):English Version

dated 31 Jan 2012

03 copies

4 Informed Consent Form-Site Specific ICF: Malyalam Final Version dated 01

Feb 2012

03 copies

5 Informed Consent Form-Site Specific ICF: Malyalam Back Translation Version

dated 01 Feb 2012

03 copies

6 Informed Consent Form – Site Specific English to Malyalam Version dated 31

Jan 2012

03 copies




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16) Dr. Susheela Rani



3 Informed Consent Form-Site Specific ICF(Dr.Susheela Rani):English Version

dated 25 Oct 2011

03 copies


2012

03 copies


dated 25 Jan 2012

03 copies


2012

03 copies


Jan 2012

03 copies


dated 27 Jan 2012

03 copies


Jan 2012

03 copies

10 Informed Consent Form-Site Specific ICF: Tamil Final Version dated 28 Jan

2012

03 copies


dated 28 Jan 2012

03 copies

12 Informed Consent Form – Site Specific English to Tamil Version dated 28 Jan

2012

03 copies




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17) Dr. Anita Goyal



3 Informed Consent Form-Site Specific ICF(Dr.Anita Goyal):English Version

dated 06 Feb 2012

03 copies


2012

03 copies


dated 07 Feb 2012

03 copies


2012

03 copies

18) Dr.Sukumar Barik



3 Informed Consent Form-Site Specific ICF(Dr.Sukumar Barik):English Version

dated 30 Jan 2012

03 copies

4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 02 Mar

2012

03 copies


dated 02 Mar 2012

03 copies




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6 Informed Consent Form – Site Specific English to Hindi Version dated 01 Mar

2012

03 copies

7 Informed Consent Form-Site Specific ICF: Bengali Final Version dated 02 Mar

2012

03 copies

8 Informed Consent Form-Site Specific ICF: Bengali Back Translation Version

dated 02 Mar 2012

03 copies

9 Informed Consent Form – Site Specific English to Bengali Version dated 01

Mar 2012

03 copies

19) Dr.Jaishree Gajraj



3 Informed Consent Form-Site Specific ICF(Dr.Jaishree Gajraj):English Version

dated 07 Feb 2012

03 copies

4 Informed Consent Form-Site Specific ICF:Tamil Final Version dated 09 Feb

2012

03 copies

5 Informed Consent Form – Site Specific English to Tamil Version dated 08 Feb

2012

03 copies


dated 09 Feb 2012

03 copies

20) Dr.Ratnaboli Chakravorty



3 Informed Consent Form-Site Specific ICF(Dr.Ratnaboli Chakravorty):English 03 copies




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2012

03 copies


dated 25 Feb 2012

03 copies


2012

03 copies

7 Informed Consent Form-Site Specific ICF: Bengali Final Version dated 25 Feb

2012

03 copies

8 Informed Consent Form-Site Specific ICF: Bengali Back Translation Version

dated 25 Feb 2012

03 copies

9 Informed Consent Form – Site Specific English to Bengali Version dated 24

Feb 2012

03 copies

21) Dr. Anita Singh



3 Informed Consent Form-Site Specific ICF(Dr.Anita Singh):English Version

dated 23 Jan 2012

03 copies


2012

03 copies


dated 25 Jan 2012

03 copies


2012

03 copies

7 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version 03 copies




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dated 25 Jan 2012

8 Informed Consent Form – Site Specific English to Hindi Version dated 24th

Jan’ 2012

03 copies

9 Informed Consent Form – Site Specific English to Marathi Version dated 24th

Jan’ 2012

03 copies

22) Dr.Uma Ram



3 Informed Consent Form-Site Specific ICF(Dr.Uma Ram):English Version

dated 16 Feb 2012

03 copies

4 Informed Consent Form-Site Specific ICF:Tamil Final Version dated 25 Feb

2012

03 copies

5 Informed Consent Form – Site Specific English to Tamil Version dated 24 Feb

2012

03 copies


dated 25 Feb 2012

03 copies

23) Dr.Mitra Saxena



3 Informed Consent Form-Site Specific ICF(Dr.Mitra Saxena):English Version

dated 15 Feb 2012

03 copies


2012

03 copies




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dated 20 Mar 2012

03 copies


2012

03 copies

24) Dr.Sreekrishna Rao



3 Informed Consent Form-Site Specific ICF(Dr.Sreekrishna Rao):English


03 copies


2012

03 copies


dated 25 Feb 2012

03 copies


2012

03 copies

25) Dr.Sonal Kotadawala



3 Informed Consent Form-Site Specific ICF(Dr.Sonal Kotadawala):English

Version dated 20 Mar 2012

03 copies

4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 27 March 03 copies




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2012


dated 27 March 2012

03 copies

6 Informed Consent Form-Site Specific ICF: Gujarati Final Version dated 27

March 2012

03 copies


dated 27 March 2012

03 copies

8 Informed Consent Form – Site Specific English to Hindi Version dated 26

March 2012

03 copies


March 2012

03 copies

26) Dr.Jayanth Rath



3 Informed Consent Form-Site Specific ICF(Dr.Jayanth Rath):English Version

dated 14 Feb 2012

03 copies

4 Informed Consent Form-Site Specific ICF: Oriya Final Version dated 07 Mar

2012

03 copies

5 Informed Consent Form-Site Specific ICF: Oriya Back Translation Version

dated 07 Mar 2012

03 copies

6 Informed Consent Form – Site Specific English to Oriya Version dated 06 Mar

2012

03 copies

27) Dr.Vidya Bhat




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3 Informed Consent Form-Site Specific ICF(Dr.Vidya Bhat):English Version

dated 26 Mar 2012

03 copies


Mar 2012

03 copies


dated 27 Mar 2012

03 copies


Mar 2012

03 copies


2012

03 copies


dated 26 Mar 2012

03 copies


2012

03 copies

28) Dr.Anita Singh



3 Informed Consent Form-Site Specific ICF(Dr.Anita Singh):English Version

dated 26 Mar 2012

03 copies


2012

03 copies


dated 26 Mar 2012

03 copies




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2012

03 copies

29) Dr.Fahmida Banu



3 Informed Consent Form-Site Specific ICF(Dr.Fahimida Banu):English Version

dated 31 Jan 2012

03 copies

4 Informed Consent Form-Site Specific ICF: Telugu Final Version dated 01 Feb

2012

03 copies

5 Informed Consent Form-Site Specific ICF: Telugu Back Translation Version

dated 01 Feb 2012

03 copies

6 Informed Consent Form-Site Specific ICF: Urdu Final Version dated 25 Feb

2012

03 copies

7 Informed Consent Form-Site Specific ICF: Urdu Back Translation Version

dated 25 Feb 2012

03 copies

8 Informed Consent Form – Site Specific English to Telugu Version dated 31 Jan

2012

03 copies

9 Informed Consent Form – Site Specific English to Urdu Version dated 24 Feb

2012

03 copies

Meeting details - .

Venue of Meeting : Model Residency CHS,605,Bapurao Jagtap Marg, Jacob

Circle ,Mahalaxmi(East),Mumbai-400011 Date 28th March 2012 Time; 11.30am to 1pm

The following members of the ethics committee attended the meeting and at the time of

voting, required quorum was present List of attendance and approval vote attached




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Dr.Walalwalkar - Chairperson

Dr.Bharati Dhorepatil - Member Secretary

Members:-

Mrs Medha Somayya,Advt.

Amit karkhanis,

Dr.CN Purandare,

Mrs. Deepti Walkar

None of the members of study team including Principal Investigator for above referenced study

were a part of the voting procedure

DECISION

Decision on Protocol No.: _P08385; Version; 1.0, Dated:25th October 2011

Opinion of the Independent Ethics Committee

We approve the study ,from ethics point of view , to be conducted in its presented form. The

validity of approval is one year from the date of approval or till the expiry of investigational product

whichever is earlier

Appropriate applicable mandatory regulatory permissions be obtained prior to commencement of

the study as well as GCP training of the study team members be done before commencement of

the study.

The Independent Ethics Committee expects to be informed about the following which is obligatory

for PI to report to IEC

1 progress – updates of the clinical study

2 any SAE occurring in the course of the study in 24 hours

3 any changes – amendments in the protocol and informed consent




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4 significant protocol deviations immediately and asks to be provided a copy of the final

report.

Sincerely,

Dr.Bharati Dhorepatil

Member Secretary,IEC,FOGSI