-
CLINICAL ETHICS FORUM "Sai_ Prasad", 1 Floor, Flat No. 6, 125/A,
Sian (West), Mumbai- 400 022. (India) Tel.. (+91 22) 24038512,
·Fax: (+91 22) 24023140· Email: [email protected]
08 January 2013
Dr. Ashok Mahashur P. D. Hinduja National Hospital & Medical
Research Centre Veer Savarkar Marg, Mahim, Mumbai- 400 016.
India
Subject: Approval by an Independent Ethics Committee
Reference: Protocol No. ISMAR 2 Study (DIREGR06411)
Title of the Protocol/study: Unmet Needs in allergic rhinitis:
International Survey on Management of Allergic Rhinitis by
Physician and Patient.
REF NO: CEF/12-13/041
Dear Sir,
The Clinical Ethics Forum, (hereinafter referred to as CEF), Sai
Prasad, 151 floor, 125/A, Sion (West), Mumbai 400 022, India at its
meeting held on 04 December 2012 at 17.30 hrs reviewed the
following documents pertaining to the above-mentioned protocol I
study.
Sr. No. Documents Version/date
I Protocol Protocol Version 1.0 dated I 0-July-20 12
2 Case Report Form Final Version 1.0 dated 10-July-2012
3 Subject Information and Informed India Version 1.0 dated
29-August-2012 Consent Form -English
4 Subject Information and Informed India Version 1.0 dated
29-August-2012 Consent Form -Hindi Hindi Translation dated
3-0ctober-2012
5 Subject Information and Informed India Version 1.0 dated
29-Aug-2012 Consent Form- Marathi Marathi Translation dated
3-0ctober-20 12
6 Subject Information and Informed India Version 1.0 dated
29-August-2012 Consent Form- Gujarati Gujarati Translation dated
3-0ctober-2012
• 7 Subject lnformation and Informed India Version 1.0 dated
29-August-2012
Consent Form - Bengali Bengali Translation dated 3-0ctober-20
12
8 Subject Information and Informed India Version 1.0 dated
29-Aug-2012 Consent Form- Tamil Tamil Translation dated
3-0ctober-20 12
9 Subject Information and Informed India Version 1.0 dated
29-Aug-2012 Consent Form - Telugu Telugu Translation dated
3-0ctober-2012
10 Subject Information and Informed India Version 1.0 dated
29-August-2012 Consent Form - Kannada Kannada Translation dated
3-0ctober-2012
-
II
12
13
14
IS
16
17
18
19
20
21
22
23
24
25
26
27
28
CLINICAL ETHICS FORUM ~Sfi.P(rasad", 1 Floor, Flat No. 6, 125/A,
Sion (West), Mumbai . 400 022. (India) e · · +91 22) 24038512, ·
Fax: (+91 22) 24023140- Email: cef [email protected]
Subject Information and Informed India Version 1.0 dated
29-Aug-20 12 Consent Form - Malaya1am Ma1ayalam Translation dated
3-0ctober-20 12
Subject Information and Informed India Version 1.0 dated
29-August-20 12 Consent Form - Urdu Urdu Translation dated
3-0ctober-20 12
Assent Statement For Children- India Version l.l dated
5-0ctober-2012 English
Assent Statement For Children- India Version 1.1 dated
5-0ctober-2012 Hindi Hindi Translation dated 5-0ctober-20 I 2
Assent Statement For Children- India Version l.l dated
5-0ctober-20 12 Marathi Marathi Translation dated 5-0etober-20
12
Assent Statement For Children- India Version 1.1 dated
5-0ctober-2012 Gujarati Gujarati Translation dated
5-0ctober-2012
Assent Statement For Children- India Version l.1 dated
5-0ctober-2012 Bengali Bengali Translation dated 5-0ctober-20
12
Assent Statement For Children- India Version 1.1 dated
5-0ctober-20 12 Tamil Tamil Translation dated 5-0ctober-20 12
Assent Statement For Children- India Version 1.1 dated
5-0etober-2012 Telugu Telugu Translation dated 5-0etober-20 I 2
Assent Statement For Children- India Version 1.1 dated
5-0ctober-20 12 Kannada Kannada Translation dated 5-0ctober-20 l
2
Assent Statement For Children- India Version 1.1 dated
5-0ctober-20 12 Malaya lam Malaya lam Translation dated
5-0ctobcr-20 12
Assent Statement For Children-Urdu India Version 1.1 dated
5-0ctober-2012 Urdu Translation dated 5-0ctober-2012
Patient Questionnaire - English Final Version 1.0 dated I
0-July-20 12
Patient Questionnaire - Hindi Final Version 1.0 dated
10-July-2012 Hindi Translation dated 25-August-20 12
Patient Questionnaire- Hindi to English Final Version 1.0 dated
10-July-2012 Hindi Back Translation dated 28-September-20 12
Patient Questionnaire- Marathi Final Version 1.0 dated
10-July-2012 Marathi Translation dated 25-/\ugust-20 12
Patient Questionnaire - Marathi to Final Vers ion 1.0 dated
10-July-2012 English Marathi Back Translation dated 26-
.September-20 12
Patient Questionnaire - Gujarati Final Version 1.0 dated
10-July-2012 Gujarati Translation dated 25-August-20 12
2
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.. ' 40 • Email: cet 08@hotmai
29 Patient Questionnaire - Gujarati to Final Version 1.0 dated
10-July-20 12 Gujarati English Back Translation dated
28-September-20 12
30 Patient Questionnaire - Bengali F inal Version LO dated I
0-July-2012 Bengali Translation dated 25-August-20 12
31 Patient Questionnaire- Bengali to English Fina l Version 1.0
dated 10-July-20 12 Bengali Back Translation dated 28-
September-20 12
32 Patient Questionnaire- Tamil Final Version 1.0 dated
10-July-20 12 Tamil Translation dated 25-August-2012
33 Patient Questionnaire - Tamil to English Final Version 1.0
dated I 0-July-2012 Tamil Back Translation dated 28-September-
2012
34 Patient Questionnaire - Telugu Final Version 1.0 dated
10-July-2012 Telugu Translation dated 25-August-2012
35 Patient Questionnaire- Telugu to English F ina l Version 1.0
dated 10-July-20 12 Telugu Back Translation dated 28-September-
2012
36 Patient Questionnaire - Kannada 1-inal Version 1.0 d ated I
0-J uly-20 12 Kannada Translation dated 25-August-20 12
37 Patient Questionnaire - Kannada to F inal Version 1.0 dated 1
0-July-20 12 Eng lish Kannada Back Translation dated 28-
September-20 12
38 Patient Questionnaire - Malayalam F inal Version 1.0 dated
10-July-2012 Malaya lam T rans lation dated 2 5-August-20 12
39 Patient Questionnaire - M alayalam to Final Version 1.0 dated
10-July-2012 English Malayala m Back Translation dated 28-
September-20 12
40 Patie nt Questionnaire - Urdu F inal Version 1.0 dated
10-July-2012 Urdu T ranslation dated 25-August-20 12
41 Patient Questionnaire - Urdu to English Final Version 1.0
dated 10-Ju ly-201 2 Urdu Back Translation dated 28-September-
2012
42 Draft CTA (Bipartite] NA
43 Draft CTA (Trpartite) NA
3
-
r -I '
~Ef CLINICAL ETHICS FORUM "Sai Prasad" 1 Floor Flat No 6 125/A
s· (We . Tel. : (+91 22) 24038S12 • Fa~: (+91 22)
2~0~31405?·EMum1.ba• 1• 400 022 (India) ' ma1 ce _
08@hotma•l.com
Details of the composition of the ethics committee and those
present for the meeting are given below:
Sr. Name I Role in EC Qualification Affiliation Present/ No
Absent
l MR.C.SHRIKHANDE B.Sc. Retired International Present -
Chairperson I Layperson Marketing Consultant for
SME's, social service at NAB, visiting faculty at business
schools.
2 DR. (MRS.) A. BAPAT M.D., D.G.O, Private Practitioner at I)
Indira Present - Member Secretary I F.C.P.S Maternity &
Surgical Nursing Gynecologist Home, Sion (W), Mumbai
2) Consultant Gynaecologist at Wellspring Medical centre.
3 MR. N. BHAGWAT B. Pharma, M.Sc. Proprietor, Ankur Landscape
Absent -Member I Pharmacist& Tech. Service, Dadar, Mumbai.
Horticulturist.
4 MS. P. BHATKAR B.A.,M.S.W. Social Worker Present - Member I
Social & NGO Worker.
5 DR. D. DHODI M.D., Lecturer in Dept of Absent - Member I
Pharmacologist. (Pharmacology) Pharmacology, Sir JJ Hospital
and Grant Medical College, IJyculla, Mumbai.
6 MS. S. GOGA TE B.Com, FCA, Practicing Chartered Present
-Member I Legal Expert LLB. (G) Accountant, Legal ExQert.
7 MS. K. JAGDHANE B.Com., LL.B., Social Worker (Sakhya Present -
Member I Social & NGO M.S.W. Women 's Guidance Cell).
Worker.
8 MR. P. KHER- M.Com., LL.B., Practicing Company Secretary,
Present Member I Legal Expert. A.C.S. Legal Expert.
9 DR. (MS.) A. KULKARNI M.D. Psychiatrist, private practice
Present -Member I Psychiatrist. and Honorary Consultant at:
1) Dhanwantari Hospital, Dadar. 2) Manav Seva Sangh.
10 Dr. (MS.) S. MALI M.D. Assistant Professor- Dept of Present -
Member I Pharmacologist. (Pharmacology) Pharmacology, Lokmanya
Tilak Municipal Medical College, Sion, Mumbai.
II Ms. Anjali M Desai - B.Sc. LL.M !.Worked in a Nationalized
Present Member I Legal Expert Bank 2. Practiced as a Civil
and Criminal Lawyer in Bombay High Court from 1985 to 2000
12 Ms. Arunima Kaushik- B.A.Mathematics Marketing Consultant -
Present
4
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CLINICAL ETHICS FORUM "Sai Prasad" 1 Floor Flat N 6 125/A s·
Tel. · (+91 22) 2403as12 • F~x· (.91 22) 2~;2~West), Mumbai • 400
022. (India) art com ' 140 · Email: cef nRfO'
Member / layperson Hons.) Diploma Freelance & Project based
in Corporate Communication Pursuing Masters in Philosophy,
Astrophysics
13 Ms. Sushama Shirodkar - M.Sc Housewife Worked as a Junior
Present Member I layperson (Biochemistry, Research Fellow from
year
University ~f 2000-2002 and a Mumbai) Senior Research Fellow
from
2002-2005 in University Dept. of Chem ical Technology,
Mumbai.
All the queries raised I and I or amendments/modifications
suggested by the CEF vide letter dated 05 December, 20 12 were
accepted and I or satisfactorily rep I ied to by the Sponsor vide
their Jetter dated 3ls1 December 2012. Subsequently, the ICFs were
amended as suggested by CEF.
The CEF members at its meeting held on 08th January 2013 at
17:30 hrs reviewed and approved the following amended documents
submitted alongwith the letter dated 3 I st December 2012
pertaining to the above mentioned protocoVstudy
Sr. Documents Version/ date No.
I Inves tigator Questionnaire Final Version I dated
10-Julv-2012
2 Subject Information Sheet and Informed Consent - lndia Version
1.2 dated 12-E nglish December-20 12
3 Translated Subject lnform;:ttion Sheet and Informed India
Version 1.2 dated 12-Consent- English to Malayalam Dec-2012
Malayalam Translation Dated 13-Dec-2012
4 Translated Subject Information Sheet and Informed India
Version 1.2 dated 12-Consent - English to Marathi Dec-2012
Marathi Translation Dated 13-Dec-2012
5 Translated Subject Information Sheet and informed India
Version 1.2 dated 12-Consent - English to Telugu Dec-2012
Telugu Translation Dated 13-Dec-20 t 2
6 Translated Subject Information Sheet and In formed India
Version 1.2 dated 12-Consent- English to Gujarati Dec-2012
Gujnrati Translation Dated 13-Dec-2012
7 Translated Subject Information Sheet and Informed ·India
Version I .2 dated 12-Consent - English to Bengali Dec-2012
Bengali Translation Dated 13-Dec-20 12
5
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140· Email r.Pf ~ i 8 Translated Subject Information Sheet and
Informed India Version 1.2 dateo 12-
Consent - English to Kannada Dcc-2012 Kannada Translation Dated
13-Dec-20 12
9 Translated Subject Information Sheet and Informed India
Version 1.2 dated 12-Consent- English to Hindi Dec-2012
Hindi Translation Dated 13-Dec-2012
10 Translated Subject Information Sheet and Informed India
Version 1.2 dated 12-Consent - Eng! ish to Tamil Dec-20 12
Tamil Translation Dated 13-Dec-2012
II Translated Subject Information Sheet and Informed India
Version 1.2 dated 12-Consent - English to Urdu Dec-2012
Urdu Translation Dated 13-Dec-2012
12 Back Translated Subject Information Sheet and India Version
1.2 dated 12-In formed Consent - Malayalam to English Dec-2012
Malayalam Back Translation Dated 14-Dec-20 12
13 Back Translated Subject Information Sheet and India Version
1.2 dated 12-Informed Consent- Marathi to English Dec-20 12
Marathi Back Translation Dated 14-Dec-20 12
14 Back Translated Subject Information Sheet and India Version 1
.2 dated 12-Informed Consent- Te1ugu to English Dec-2012
Telugu Back Translation Dated 14-Dec-20 12
15 Back Translated Subject Information Sheet and India Version
1.2 dated 12 -Informed Consent- Gujarati to English Dec-2012
Gujarati Back Translation Dated I 4-Dec-20 12
16 Back Translated Subject Information Sheet and India Version
1.2 dated 12-Informed Consent- Bengali to English Dec-201 2
Bengali Back Translation Dated 14-Dec-2012
17 Back Translated Subject Information Sheet and fndia Version I
.2 dated 12-Informed Consent- Kannada to English Dec-2012
Kannada Back T ranslation Dated 14-Dec-2012
18 Back Translated Subject information Sheet and India Version
1.2 dated 12-Informed Consent- Hindi to English Dec-2012
Hindi Back Translation Dated 14-Dec-2012
6
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CLINICAL ETHICS FORUM 'Sai Prasad', 1 Floor. Flat No 6 125/A, s·
(We . Tel · ('t91 22) 24038512 Fa · (+91 22) 2 ton st), Mumba1 -
400 022 (India) I com
.. x: 4023140· Email· r.Pf India Version l.2 dated' IZ-
I 19 Back Translated Subject Information Sheet and
Informed Consent- Tamil to English Dcc-2012 Tamil Back
Translation Dated 14-Dec-2012
20 Back Translated Subject Information Sheet and India Version
1.2 dated 12-Informed Consent - Urdu to English Dec-2012
Urdu Back Translation Dated 14-Dec-2012
21 Assent Statement Form - English India version 1.2 dated
27-Nov-2012
22 Translated Assent Statement Form - English to lndia Version
1.2 dated 27-Telugu Nov-2012
Telugu Translation Dated 29-Nov-20 12
23 Translated Assent Statement Form - English to India Version
1.2 dated 27-Bengali Nov-2012
Bengali Translation Dated 29-Nov-20 12
24 Translated Assent Statement Form - English to India Version
1.2 dated 27-Gujarati Nov-2012
Gujarati Translation Dated 29-Nov-20 12
25 Translated Assent Statement Form- English to Hindi India
Version 1.2 dated 27-Nov-2012 Hindi Translation Dated
29-Nov-2012
26 Translated Assent Statement Form - English to India Version
1.2 dated 27-Kannada Nov-2012
Kannada Translation Dated 29-Nov-2012
27 Translated Assent Statement Form - English to lndia Version
1.2 dated 27-Malayalam Nov-2012
Malayalam Translation Dated 29-Nov-2012
28 Translated Assent Statement Form - English to India Version
1.2 dated 27-Telugu Nov-2012
Telugu Translation Dated 29-Nov-2012
29 Translated Assent Statement Form - English to lndia Version
1.2 dated 27-Marathi Nov-2012
Marathi Translation Dated 29-Nov-20 12
7
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CLINICAL ETHICS FORUM ~sri. P(~;ag;) 1Jioor. Flat No .. s.
125/A, Sian (West). Mumba1 - 400 022. (India) e · · + 038512, ·Fax.
(+91 22) 24023140· Email· cef [email protected]
30 Translated Assent Statement Form - English to Tamil India
Version 1.2 dated 27-Nov-2012 Tamil Translation Dated
29-Nov-2012
31 Translated Assent Statement Form- English to Urdu India
Version 1.2 dated 27-Nov-2012 Urdu Translation Dated
29-Nov-2012
32 Back Translated Assent Statement Form - Telugu to India
Version I .2 dated 27-English Nov-2012
Telugu Back Translation Dated 30-Nov-2012
33 Back Translated Assent Statement Form - Bengali to India
Version 1.2 dated 27-English Nov-2012
Bengali Back Translation Dated 30-Nov-20 12
34 Back Translated Assent Statement Form - Gujarati India
Version 1.2 dated 27-to English Nov-2012
Gujarati Back Translation Dated 30-Nov-20 12
35 Back Translated Assent Statement Form - Hindi to India
Version 1.2 dated 27-English Nov-2012
Hindi Back Translation Dated 30-Nov-20 12
36 Back Translated Assent Statement Form - Kaooada India Version
1.2 dated 27-to English Nov-2012
Kannada Back Translation Dated 30-Nov-201 2
37 Back Translated Assent Statement Form - India Version 1.2
dated 27-Malayalam to English Nov-2012
Malaya lam Back Translation Dated 30-Nov-2012
38 Back Translated Assent Statement Form - Marathi to India
Version 1.2 dated 27-English Nov-2012
Marathi Back · Translation Dated 30-Nov-20 12
39 Back Translated Assent Statement Form - Urdu to India Version
1.2 dated 27-English Nov-/ 012
Urdu Back Translation Dated 30-Nov-2012
8
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40 Back Translated Englis h
CLINICAL ETHICS FORUM ·s a i Prasad", 1 Floor, Fla t No.6,
125/A, Sion (West), Mumbai- 400 022. (l~dia) Tel. : (+91 22)
24038512, • Fax: (+91 22) 24023140 · Email: [email protected]
A ssent Statement Fonn - Tlunil to India Versio n 1.2 dated
27-Nov-2012 · Tamil Back Translation Dated 30-Nov-20 12
Details of the composition of the ethics committee and those
present for the meeting are g iven below:
Sr. Na m e I Role in EC Q u a lification Affiliation Presen t/
No Absen t
I MR.C.SHRIKHAN D E B.Sc. Reti re d International Present -
Chairperson I Layperson Marketing Consultant for
SME's, social service at NAB, visiting faculty at b u siness
schools.
2 DR. (MRS.) A. BAPAT M.D., D.G.O, Private Practitio ner at I )
I n d ira Present - Memb er Secretary I F.C.P.S Maternity &
Surgical Nursing Gynecologis t Home, S ion (W), M u m b ai
2) Consultant Gynaecologist at Wellspring M e dical centre.
3 MR. N. BHAGWAT B. Pharm a, M.Sc. Proprietor , Ankur Landscape
Absent -Member I Pharmacist& Tech. Service, Dadar, Mumbai.
Horticulturist.
4 MS. P. BHATKAR B.A., M.S.W. Social Worke r Present -Member I
Socia l & NGO Worker.
5 DR. D. D I IODI M.D., Lectu rer in D ept o f Absen t - Member
I Pharmacologist. (Ph a rmacology) Pharmacology, S ir J J
Hospital
a n d Grant Medical College, B yculla, Mumba i.
6 MS. S. GOGA TE B.Com, FCA, P racticing Chartered Present -
Member I Legal Expert LLB. (G) Accountant, Legal Expert.
7 MS . K. JAGDf iANE B.Com ., LL.B., Social Worke r (Sakhya
Present - Membe r I Social & NCO M.S.W. Women 's Guidance Cell)
. Worker.
g MR.P. K H E R- M.Com ;, LL.B., Practicing Company Secr etary,
Present Member I Legal Expert. A.C.S. Legal Expert.
9 DR. (MS.) A. KULKARNI M.D. Psychiatris t, private p ractice
Present -Member I Psychiatrist. and Honorary Con s ultant at:
I) Dhanwantari Hospital, D a dar. 2) M a nav Seva Sangh.
10 Dr. (MS.) S . MALI M.D. A ssistant Professor- Dept of Present
- Mem ber I Pharmacologis t . (Pharm a c o logy) P h armacology,
Lokmanya
Tilak Munic ipal Medical College, Sion, Mumbai.
9
-
11 Ms. Anjali M Desai -Member I Legal Expert
12 Ms. Arunima Kaushik-Member I layperson
13 Ms. Sushama Shirodkar-Member I layperson
CLINICAL ETHICS FORUM 'Sai. Prasad', 1 Floor, Flat No. 6, 125/A,
Sian (West), Mumba1 • 400 022 (India) Tel . . (+91 22) 24038512,
·Fax: (+91 22) 24023140· Email: cef 08@hot~il.com -
B.Sc. LL.M I. Worked in a Nationalized Present Bank 2. Practiced
as a. Civil and Criminal Lawyer in Bombay High Court from 1985 to
2000
B.A.Mathematics Marketing Consultant- Present Hons.) Diploma
Freelance & Project based in Corporate Communication Pursuing
Masters in Philosophy, Astrophysics
M.Sc Housewife Worked as a Junior Absent (Biochemistry, Research
Fellow from year University of 2000-2002 and a Mumbai) Senior
Research Fellow from
2002-2005 in University Dept. of Chemical Techno logy,
Mumbai.
F inal list of approved documents is as follows:
The study is approved and the following documents are approved
at the meeting held on 81h January 2013.
Sr. No. Documents Version/date
I. Protocol Protocol Version 1.0 dated 10-July-2012
2. Case Report Form Final Version l.O dated 10-July-2012
Subject Information Sheet and Informed India Vers ion 1.2 dated
12-Dec-201 2 3. Consent - English
4. Patient Questionnaire- English Final Vers ion l.O dated
10-July-2012
Patient Questionnaire- Ilindi Final Version l.O dated 1
0-July-20 12 5. Hindi Translation dated 25-August-20 12
Patient Questionnaire - Hindi to Final Version 1.0 dated
10-July-2012 Hindi 6. English Back Translation dated
28-September-20 12
Patient Questionnaire - Marathi Final Vers ion 1.0 dated
10-July-2012 Marathi 7. Translation dated 25-August-20 12
Patient Questionnaire - Marathi to Final Vers ion 1.0 dated
10-July-2012
8. English Marathi Back Translation dated 26-September-20 12
9. Patient Questionnaire - Gujarati Final Vers ion l.O dated
10-July-20 12
Gujarati Translation dated 25-August-20 12
10
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10.
II.
12.
13.
14.
15.
16.
17.
18.
19.
20.
2 1.
22.
23.
24.
25.
26.
CLINICAL ETHICS FORUM ·sai Prasad·. 1 Floor, Flat No. 6, 125/A,
Sion (West), Mumbai- 400 022. (India) Tel. : (+91 22) 24038512, •
Fax· (+91 22) 24023140· Email· [email protected]
Puticnt Question11aire- Gujarati to Final Version 1.0 dated l
0-July-20 12 Gujarati English Back Translation dated
28-September-2012
Patient Questionnaire - Bengali Final Version 1.0 dated
10-July-2012 Bengali Translation dated 25-August-2012
Patient Questionnaire- Bengali to Final Version 1.0 dated
10-July-2012 English Bengali Back Translation dated 28-
September-20 12
Patient Questionnaire - Tamil Final Version 1.0 dated l
0-July-20 12 Tamil Translation dated 25-August-2012
Patient Questionnaire- Tamil to Final Version 1.0 dated
10-July-2012 English Tamil Back Translation dated 28-Septembcr-
2012
Patient Questionnaire - Telugu Final Version 1.0 dated
10-July-2012 Telugu Translation dated 25-August-20 12
Patient Questionnaire - Telugu to Final Version 1.0 dated
10-July-2012 English Telugu Back Translation dated
28-September-
2012
Patient Questionnaire - Kannada Final Version 1.0 dated I
0-July-20 12 Kannada Translation dated 25-August-20 12
Patient Questionnaire - Kannada to Final Version 1.0 dated
10-July-2012 English Kannada Back Translation dated 28-
September-2012
Patient Questionnaire - Malayalam Final Version 1.0 dated
10-July-2012 Malaya lam Translation dated 25-August-20 12
Patient Questionnaire - Malaya lam to Final Version 1.0 dated I
0-July-2012 English Malayalam Back Translation dated 28-
Scptember-20 12
Patient Questionnaire - Urdu Final Version 1.0 dated 1 0-July-20
12 Urdu Translation dated 25-August-2012
Patient Questionnaire - Urdu to English Final Version 1.0 dated
10-July-2012 Urdu Back Translation dated 28-Septt:mber-
2012
Draft CTA [Bipartite] NA
Draft CTA [Tripartite] NA
Investigator Questionnaire Final Version 1 dated
10-July-2012
Translated Subject Information Sheet India Version 1.2 dated
12-Dec-20 12 and Informed Consent - E nglish to Malayalam
Translation Dated 13-Dec-Malaya lam 2012
11
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27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
CLINICAL ETHICS FORUM 'Sai Prasad", 1 Floor, Flat No.6 125/A,
Sion (West), Mumbai . 400 022. (India) Tel. : (+91 22) 24038512, •
Fax: (+91 22) 24023140· Email: cef [email protected] -
Translated Subject Information Sheet India Version 1.2 dated
12-Dec-2012 and Informed Consent - English to Marathi Translation
Dated 13-Dec-2012 Mnrathi
Translated Subject Information Sheet India Version 1.2 dated
12-Dec-20 12 and Informed Consent - English to Telugu Translation
Dated 13-Dec-20 12 Telugu
Translated Subject Information Sheet India Version 1.2 dated
12-Dcc-20 12 and Informed Consent - Engl ish to Gujarati
Translation Dated 13-Dec-20 I 2 Gujarati
Translated Subject Information Sheet India Version 1.2 dated
12-Dcc-20 12 and Informed Consent - English to Bengali Translation
Dated 13-Dec-20 12 Bengali
Translated Subject Information Sheet India Version 1.2 dated
12-Dec-2012 and Informed Consent - English to Kannada Translation
Dated 13-Dec-20 12 Knnnada
Translated Subject Information Sheet India Version 1.2 dated
12-Dec-2012 and Informed Consent - English to Hindi Translation
Dated 13-Dec-2012 H indi
Translated Subject Information Sheet India Version 1.2 dated
12-Dec-2012 and Informed Consent - English to Tamil Translation
Dated 13-Dec-2012 Tamil
Translated Subject Information Sheet India Version 1.2 dated
12-Dec-2012 and Informed Consent - English to Urdu Translation
Dated 13-Dec-2012 Urdu
Back Translated Subject Information India Vers ion 1.2 dated
12-Dec-201 2 Sheet and Informed Consent - Malaya lam Back
Translation Dated 14-Malayalam to English Dcc-2012
Back Translated Subject Information India Version 1.2 dated
12-Dec-2012 Sheet and Informed Consent - Marathi Back Translation
Dated 14-Dec-Marathi to English 2012
Back Translated Subject Information India Version 1.2 dated
12-Dec-20 12 Sheet and Informed Consent - Telugu Back Translation
Dated 14-Dec-Telugu to English 2012
Back Translated Subject Information India Version 1.2 dated
12-Dec-20 12 Sheet and Informed Consent - Gujarati Back Translation
Dated 14-Dec-Gujarati to English 2012
Back Translated Subject Information India Version 1.2 dated
12-Dec-2012 Sheet and Informed Consent - Bengali Back Translation
Dated 14-Dcc-Bengali to English 2012
12
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f;Ef 40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
CLINICAL ETHICS FORUM ·sa; Prasad", 1 Floor, Flat No.6, 125/A,
Sion (West), Mumbai - 400 022. (India) Tel.: (+91 22) 24038512, ·
Fax: (+91 22) 24023140 · Email. [email protected]
Back Translated Subject Information India Version 1.2 dated
12-Dec-20 12 Sheet and Informed Consent - Kannada Back Translation
Dated 14-Dec-Kannada to English 2012
Bac k Translated Subject In formation India Version 1.2 dated
12-Dec-2012 Sheet and Informed Consent - Hindi Hindi Back
Translation Dated 14-Dec-to E nglish 2012
Back Translated Subject Information India Version 1.2 dated
12-Dcc-20 12 Sheet and Informed Consent- Tamil Tamil Back
Translation Dated 14-Dec-to E nglis h 2012
Back Translated Subject Information India Version 1.2 dated
12-Dec-2012 Sheet and Informed Consent- Urdu Urdu Back Translation
Dated 14-Dec-2012 to E nglish
Assent Statement Form - English India version 1.2 dated
27-Nov-2012
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-2012 English to Telugu Telugu Translation Dated
29-Nov-2012
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-2012 English to Bengali Bengali Translation Dated 29-Nov-20
12
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-2012 E nglish to Gujarati Gujarati Translation Dated
29-Nov-20 12
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-2012 English to Hindi Hindi Translation Dated
29-Nov-2012
Translated Assent Statef!lent Form - India Version 1.2 dated
27-Nov-2012 English to Kannada Kannada Translation Dated 29-Nov-20
12
Translated Assent Statement Form - Ind ia Version 1.2 dated
27-Nov-2012 E nglish to Malayalam Malayalam Translation Dated
29-Nov-
2012
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-20 12 English to Telugu Telugu Translation Dated 29-Nov-20
12
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-2012 English to Mnruthi Marathi T ranslation Dated 29-Nov-20
12
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-2012 English to Tamil Tamil Translation Dated
29-Nov-2012
Translated Assent Statement Form - India Version 1.2 dated
27-Nov-2012 E ng lish to Urdu Urdu Translation Dated
29-Nov-2012
Back Translated Assent Statement Ind ia Version 1.2 dated
27-Nov-2012 Fonn - Tclugu to English Telugu Back Translation Dated
30-Nov-
2012 13
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CLINICAL ETHICS FORUM "Sai Prasad", 1 Floor, Flat No. 6, 125/A,
Sion (West). Mumba1- 400 022. (lf"!dia) Tel. : (+91 22) 24038512, •
Fax: (+91 22) 24023140 · Email: [email protected]
Back Translated Assent Statement India Version 1.2 dated
27-Nov-20 I 2
56. Form - Ben gali to E nglish Bengali Back T ranslation Dated
30-Nov-
2012
Back Translated A ssent Statement India Version 1.2 dated
27-Nov-20 12
57. Form - G uja r ati to English Gujarati Back Translation
Dated 30-Nov-2012
Back Translated Assent Statement India Vers ion 1.2 dated
27-Nov-20 12
58. Form - Hindi to English H i ndi Back Translation Dated
30-Nov-2012
Back Translated A ssent S tatement India Version 1.2 dated 27
-Nov-20 12
59. Form - Kannada to English Kannada Back Trans lation Dated
30-Nov-2012
Back Translated A sse nt Statement India Version 1.2 dated
27-Nov-2012
60. Form - Malayalam to English Malayalam Back Translation Dated
30-Nov-2012
Back Translated Assent Statement India Vers ion 1.2 dated
27-Nov-2012
61. Form - Marathi to English Marathi Back Translation Dated
30-Nov-2012
Back Translated Assent Statement India Version 1.2 dated
27-Nov-2012
62. Form - Urd u to E n glish Urdu 2012
Dack Translation Dated 30-Nov-
Back Translated Assent Statement India Version 1.2 dated
27-Nov-2012
63 . Form -Tamil to English Tamil 2012
Back Trans la tion Dated 30-Nov-
The CEF approves the study to be conducted in its presented
form, subject to the approval of the D r ugs Controller General
(India) and /or all the regulatory authorities, if I as required.
Conditions, if any, imposed by the DCGI or any applicable
regulatory authority have to be strictly adhered to.
Review and approval of this study by the CEF is not an
endorsement of the s tudy or its outcome.
A copy of the t·elevant insurance policy which covers com
pensation to the pa rticipant in case of injury and I or cleath
should be sent to the CEF before commencement of the study, if this
is required by regulato ry authorities.
The present approval is valid on ly if study is ini tiated
within one year from the date of approval.
The members present were more than the required quorum of five,
with at least one medically qualified person and at least one
layperson present. All the members voted for approval and none
voted aga inst.
We hereby confirm that n either you nor any of your study team
members have participated in the vot ing/ decision making procedure
of th e committee. The members of the committee who have
14
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CLINICAL ETHICS FORUM ·sai Prasad", 1 Floor, Flat No.6, 125/A,
Sion (West), Mumbai - 400 022. (India) Tel.: (+91 22) 24038512, ·
Fax: {+91 22) 24023140 · Ematl· [email protected]
pa1ticipated in the voting! decision making procedure of the
committee do not have any conflict of interest in the referenced
study. ·
Please do not implement any deviation from I or change to, the
protocol approved without prior approval of this ethics committee
only when necessary to eliminate immediate hazards to subjects or
when changes involve only logistical or administrative aspects of
the trial [e.g. change of study monitor(s), telephone
numbers(s)].
Kindly ensure the CEF is informed of all modifications or
deviations in the protocoL Any modification of I amendment to the
protocol must be approved by the CEF. The Investigator is required
to conduct the study as per the recommended GCP guidelines.
Kindly keep the CEF informed about the progress of the study,
any SAE which may occur in the course of the study and any changes
to the protocol and patient information I informed consent form/s
and new information that may adversely aiTect adversely the safety
of the subjects or the conduct of the study.
The Principal Investigator is requested to submit the progress
report within s ix months, after completion of the study, to the
CEF for review.
We confirm that our ethics committee is constituted and
functions as per the Good Clinical Practices guidelines issued by
the Central Drugs Standard Control Organization, the Schedule Y of
the Drug and Cosmetics Act 1940, as amended from time to time, the
Ethics Guidelines for Biomedical Research on human subjects, issued
by Indian Council of Medical Research and Declaration of Helsinki,
1964, as moditled by the World Medical Association, Seoul, 2008 and
updated/ amended from time-to-time.
Yours Sincerely
Dr. Anjali Bapat
(Member Se~a'r'J•cef(:£
Clinical Ethics
15
