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Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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:
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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
Version 01 dated 26 December 2011
03 copies
4. Appendix II Questionnaire Part B-For participating Women ,Gujarati
Version 01 dated 26 December 2011
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
12 Counseling Sheet for hormone related contraceptives Back Translated
from Tamil to English 09 February 2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
13 Counseling Sheet for hormone related contraceptives Translated from
English to Hindi 09 February 2012
03 copies
14 Counseling Sheet for hormone related contraceptives Back Translated
from Hindi to English 09 February 2012
03 copies
15 Counseling Sheet for hormone related contraceptives Translated from
English to Kannada 09 February 2012
03 copies
16 Counseling Sheet for hormone related contraceptives Back Translated
from Kannada to English 09 February 2012
03 copies
17 Counseling Sheet for hormone related contraceptives Translated from
English to Gujarati 09 February 2012
03 copies
18 Counseling Sheet for hormone related contraceptives Back Translated
from Gujarati to English 09 February 2012
03 copies
19 Counseling Sheet for hormone related contraceptives Translated from
English to Bengali 09 February 2012
03 copies
20 Counseling Sheet for hormone related contraceptives Back Translated
from Bengali to English 09 February 2012
03 copies
21 Counseling Sheet for hormone related contraceptives Back Translated
from Urdu to English 16 February 2012
03 copies
22 Counseling Sheet for hormone related contraceptives Translated from
English to Urdu 16 February 2012
03 copies
23 Counseling Sheet for hormone related contraceptives Back Translated
from Malyalam to English 10 February 2012
03 copies
24 Counseling Sheet for hormone related contraceptives Translated from
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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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
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.Rupashree Bhoyar):English
Version dated 23 Jan 2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 25 Jan
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
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
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. Rupam Arora):English Version
dated 07 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 07 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 08 Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 07 Feb
2012
03 copies
4) Dr. Kiran Desai
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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.Kiran Desai):English Version
dated 23 Jan 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 24 Jan
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
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
9 Informed Consent Form – Site Specific English to Gujarati Version dated 23
Jan 2012
03 copies
5) Dr. Gayatri Deshpande
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. Gayatri Deshpande):English
Version dated 27 Jan 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 28 Jan
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 28 Jan 2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
6 Informed Consent Form-Site Specific ICF: Marathi Final Version dated 28 Jan
2012
03 copies
7 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 28 Jan 2012
03 copies
8 Informed Consent Form – Site Specific English to Hindi Version dated 27 Jan
2012
03 copies
9 Informed Consent Form – Site Specific English to Marathi Version dated
27Jan 2012
03 copies
6) Dr. Avan Dadina
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. Avan Dadina):English Version
dated 27 Jan 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 28 Jan
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 28 Jan 2012
03 copies
6 Informed Consent Form-Site Specific ICF: Marathi Final Version dated 28 Jan
2012
03 copies
7 Informed Consent Form-Site Specific ICF: Marathi Back Translation Version
dated 28 Jan 2012
03 copies
8 Informed Consent Form – Site Specific English to Hindi Version dated 27 Jan
2012
03 copies
9 Informed Consent Form – Site Specific English to Marathi Version dated 27
Jan 2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
7) Dr. Deepa Singh
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. Deepa Singh):English Version
dated 17 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 17 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 18
Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 17 Feb
2012
03 copies
8) Dr.Poonam Gupta
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.Poonam Gupta):English Version
dated 17 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 18 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 18
Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 17 Feb
2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
9) Dr.Sunita Chandra
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.Sunita Chandra):English Version
dated 06 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 07 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
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
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. 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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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.Priti Vyas):English Version dated
08 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 09 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 09 Feb 2012
03 copies
6 Informed Consent Form-Site Specific ICF: Marathi Final Version dated 09 Feb
2012
03 copies
7 Informed Consent Form-Site Specific ICF: Marathi Back Translation Version
dated 09 Feb 2012
03 copies
8 Informed Consent Form – Site Specific English to Hindi Version dated 09 Feb
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
11 Informed Consent Form-Site Specific ICF: Gujarati Back Translation Version
dated 09 Feb 2012
03 copies
12 Informed Consent Form – Site Specific English to Gujarati Version dated 08
Feb 2012
03 copies
12) Dr.Pallaniappan
1 Copy of the Undertaking of the Investigator 03 copies
2 Copy of the CV of Principal Investigator 03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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
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.Krishna Kumari):English Version
dated 31 Jan 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 01 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 01 Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 31 Jan
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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
14) Dr. Pushpa Jaiswal
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.Pushpa Jaiswal):English Version
dated 06 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 07 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 07 Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 06 Feb
2012
03 copies
15) Dr. Priyadarhini
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.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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
16) Dr. Susheela Rani
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.Susheela Rani):English Version
dated 25 Oct 2011
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 25 Jan
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 25 Jan 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 24 Jan
2012
03 copies
7 Informed Consent Form-Site Specific ICF: Kannada Final Version dated 27
Jan 2012
03 copies
8 Informed Consent Form-Site Specific ICF: Kannada Back Translation Version
dated 27 Jan 2012
03 copies
9 Informed Consent Form – Site Specific English to Kannada Version dated 25
Jan 2012
03 copies
10 Informed Consent Form-Site Specific ICF: Tamil Final Version dated 28 Jan
2012
03 copies
11 Informed Consent Form-Site Specific ICF: Tamil Back Translation Version
dated 28 Jan 2012
03 copies
12 Informed Consent Form – Site Specific English to Tamil Version dated 28 Jan
2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
17) Dr. Anita Goyal
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.Anita Goyal):English Version
dated 06 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 07 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 07 Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 06 Feb
2012
03 copies
18) Dr.Sukumar Barik
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.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
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 02 Mar 2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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
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.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
6 Informed Consent Form-Site Specific ICF: Tamil Back Translation Version
dated 09 Feb 2012
03 copies
20) Dr.Ratnaboli Chakravorty
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.Ratnaboli Chakravorty):English 03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
Version dated 14 Feb 2012
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 25 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 25 Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 24 Feb
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
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.Anita Singh):English Version
dated 23 Jan 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 25 Jan
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
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: Hindi Back Translation Version 03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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
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.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
6 Informed Consent Form-Site Specific ICF: Tamil Back Translation Version
dated 25 Feb 2012
03 copies
23) Dr.Mitra Saxena
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.Mitra Saxena):English Version
dated 15 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 20 Mar
2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 20 Mar 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 19 Mar
2012
03 copies
24) Dr.Sreekrishna Rao
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.Sreekrishna Rao):English
Version dated 06 Feb 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 07 Feb
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 25 Feb 2012
03 copies
6 Informed Consent Form – Site Specific English to Hindi Version dated 07 Feb
2012
03 copies
25) Dr.Sonal Kotadawala
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.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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
2012
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 27 March 2012
03 copies
6 Informed Consent Form-Site Specific ICF: Gujarati Final Version dated 27
March 2012
03 copies
7 Informed Consent Form-Site Specific ICF: Gujarati Back Translation Version
dated 27 March 2012
03 copies
8 Informed Consent Form – Site Specific English to Hindi Version dated 26
March 2012
03 copies
9 Informed Consent Form – Site Specific English to Gujarati Version dated 26
March 2012
03 copies
26) Dr.Jayanth Rath
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.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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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.Vidya Bhat):English Version
dated 26 Mar 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Kannada Final Version dated 26
Mar 2012
03 copies
5 Informed Consent Form-Site Specific ICF: Kannada Back Translation Version
dated 27 Mar 2012
03 copies
6 Informed Consent Form – Site Specific English to Kannada Version dated 26
Mar 2012
03 copies
7 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 26 Mar
2012
03 copies
8 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 26 Mar 2012
03 copies
9 Informed Consent Form – Site Specific English to Hindi Version dated 26 Mar
2012
03 copies
28) Dr.Anita Singh
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.Anita Singh):English Version
dated 26 Mar 2012
03 copies
4 Informed Consent Form-Site Specific ICF: Hindi Final Version dated 27 Mar
2012
03 copies
5 Informed Consent Form-Site Specific ICF: Hindi Back Translation Version
dated 26 Mar 2012
03 copies
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
6 Informed Consent Form – Site Specific English to Hindi Version dated 26 Mar
2012
03 copies
29) Dr.Fahmida Banu
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.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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
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
Independent Ethics Committee FOGSI
Model Residency CHS , 605, Bapurao Jagtap Marg, Jacob circle , Mahalaxmi East , Mumbai-11
Telephone Contact Fax Contact
32954564 / 23021648 / 23021654 / 23021343 23021383
Country Code – 91 / City Code – 22 Country Code – 91 / City Code - 22
Email: [email protected]
4 significant protocol deviations immediately and asks to be provided a copy of the final
report.
Sincerely,
Dr.Bharati Dhorepatil
Member Secretary,IEC,FOGSI