Apollo •• ~ ETHICS COMMllTEE Hospitals OnS2-243300....
Transcript of Apollo •• ~ ETHICS COMMllTEE Hospitals OnS2-243300....
TOUCHING LIVES
ApolloHospitalsBilaspur
•• ~ ETHICS COMMllTEE~ ~11o Hospital
Seepat Road.Silaspur (C.G.)Ph.: OnS2-243300. Fax:;;:;rnS2-4 .
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To
Dr. Kalpana Dash
Apollo Hospitals, Bllaspur
Lingiadih Village, Seepat Road
Bilaspur (Chhattisgarh)
Reference NN1250-3725: An Extension to NN1250-3585 Investigating safety and efficacyof NN1250 compared to insulin detemir in subject with type 1 diabetes mellitusin a Basal! Bolus treatment regimen '. ."
',., .
Subject Approval to Conduct the study above mentioned Study in your hospital
Dear Dr. Kalpana Dash
This is with reference to your letter dated on 6 Sep, 2010 to the Committee.
Institutional Ethics Committee reviewed and discussed your application to conduct
the clinical trial entitled "NN1250-3725: An Extension to NN1250-3585
Investigating safety and efficacy of NN1250 compared to insulin detemir
in subject with type 1 diabetes mellitus in a Basall Bolus treatment
regimen" On 16 Sep, 2010 ECMeeting Date.
The following documents were reviewed:
Study code- NN1250-3725:
1. Subject Information/Informed Consent Form- English
2. Subject Diaries- English
3. Subject Identification Card- English
4. Investigators Brochure
5. eCRF Mock up
6. Glucometer usage Instructions
7. Certificate of Insurance (Global)
SeepatRoad,Bilaspur495 006 Chhatisgarh,Phone: 07752-248300-05, 414805Fax: 07752-409999Emergency IAmbulance : 1066/243310/414514
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8. Undertaking by Investigator
9. Reason for extension
10. Material handling and lab details
11. Consolidated Protocol including App A & B, dated: 10.May, 2010, Version 1.0,
Status Final
12. Protocol Substantial Amendment no. 1 App A & B, dated: 04.May, 2010, Version
1.0, Status Final.
13. Protocol Non-Substantial Amendment no. 1 App A & B, dated: 07.May, 2010,
Version 1.0, Status Final.
14. Subject lnformationlInformed Consent Form, Dated: 20.Jul, 2010, English- India-
Apollo Hospitals Bilaspur- Site no. 202, Version - 2.0_ IN, Status: Final.
15. Subject Information/Informed Consent form BT_Dated : 18.Aug, 2010, Hindi to
English- India- Apollo Hospitals Bilaspur- Site no. 202, Version - 2.0_ IN, Status:
Final.(Back Translation From Hindi to English)
16. Subject Information/Informed Consent Form for a Trial Subject's Female
PARTNER in case of pregnancy, Dated: 22.Jul, 2010, English- India- Apollo
Hospitals Bilaspur- Site no.: 202, Version-l.O_IN, Status: Final.
17. Subject InformationlInformed Consent Form for a Trial Subject's Female
PARTNER in case of pregnancy, Dated: 28.Jul, 2010, Hindi- India- Apollo
Hospitals Bilaspur- Site no.: 202, Version-l.O_IN, Status: Final.
18. Subject lnformationlInformed Consent Form for a Trial Subject's Female
PARTNER in case of pregnancy, Dated: 28.Jul, 2010, Hindi to English- India-
Apollo Hospitals Bilaspur- Site no.: 202, Version-l.O_IN, Status: Final. .(Back
Translation From Hindi to English)
Seepat Road,BiJaspur495 006 Chhatisgarh,Phone: 07752-248300-05, 414805Fax: 07752-409999Emergency IAmbulance: 1066/243310/414514
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11,110BOSP'TALS
TOUCHING LIVES
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~ ETHICS COMMRTEE.Al' AfIOIIo Hospital~ Seepat Road,ailasp\Jf (C. G.)
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19. Subject Diary_English_India_ V3l, V32, V34, V36, V38, V40 & V42, Dated:
20Jul, 2010, Version-l.O_IN, Status- Final.
20. Subject Diary_English_India_ V33, V35, V37, V39, V71, V43 & V44, Dated:
20.Jul, 2010, Version-2.0_IN, Status- Final.
2l. Subject Diary_English_India_ V45 Dated: 20.Jul, 2010, Version-3.0_IN, Status-
Final.
22. Subject Diary_Hindi_India_ V31, V32, V34, V36, V38, V40 & V42, Dated:
14.Aug, 2010, Version-1.0_IN, Status- Final.
23. Subject DiaryHindiJndia , V33, V35, V37, V39, V7l, V43 & V44, Dated:
14.Aug, 2010, Version-2.0_IN, Status- Final.
24. Subject Diary_Hindi_India_ V45 Dated: 14.Aug, 2010, Version-3.0_IN, Status-
Final.
~eepatRoad,Bilaspur 495006 Chhatisgarh,Phone: 07752-248300-05, 414805Fax: 07752-409999Emergency IAmbulance: 1066/243310/414514
,~i~,'~Apollo fA~ETHICS COMMllTEEIIJ • ApOllo Hospital .)(""0110 Hospitals See,at Road, Bilaspur (C. G.)eOSPITALS Bilaspur Ph.: 07752-~4331O,Fax: On52-4~99
_TO_UC_' "_'N_O _"V_E_S Date¥.lai.f.l~Sign~;'
.The following members of the ethics committee were present at the meeting held
on 16 sep, 2010 at 12:30 pm Apollo Hospitals Bilaspur (C.G)
Title (e.g.Head, Dept.of_; Socialworker, Affiliation (Name of Institute!
Name and Role Lawver) Organization, or None)Dr P Khapre Scientific Medical Director, Railway( Chairman) (M.D.)
Dr.S.K Mohanty Scientific CIMS, Bilaspur(MS) Prof & HOD Surgery
Mr Prashant Jayaswal Senior Chhattisgarh High Court,Advocate Bilaspur
Dr (Brig.) S. K. Sharma Scientific COO cum OMS, Apollo,(MS) Hospitals, Bilaspur
Dr Sunil Sharma Scientific Sr. Consultant, Neurosurgery,(MS, MCh) Apollo Hospitals, Bilaspur
Dr A Jayavelu Scientific Sr. Consultant, Neurology,( Secretary ) (MD, OM) Apollo Hospitals, BilaspurMr. Sanjay Agrawal Non- Medical Social Worker
ScientificScientific Sr. Consultant, ENT, Apollo
Dr P P Misra (MS, FRCS) Hospitals, BilaspurDr Sushree Parida Scientific Sr. Consultant, Oncology,
(MD, OM) Apollo Hospitals, BilaspurDr Rashmi Sharma Scientific Sr. Consultant, Obstetrics and
(MS, Gynaecology, ApolloMRCOG) Hospitals, Bilaspur
Dr. P. K. Panda Scientific Sr. Consultant, Microbiology,(M.D.) Apollo Hospitals, Bilaspur
Ms.Indu Non- CEO Secretary, Apolloscientific Hospitals, Bilaspur
Seepat Road,Bilaspur495 006 Chhatisgarh.Phone: 07752-248300-05,414805Fax: 07752-409999Emergency IAmbulance : 1066/243310/414514
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We approve the trial to be conducted in its presented form under your direction atApollo Hospitals Bilaspur (C.G)
We have noted that the biological samples from study patients participating in thestudy will be sent to the central laboratory for antibody analysis as required by theprotocol and the Ethics Committee does not have any objection to the same.
Institutional Ethics Committee expects to be informed about the progress of thestudy, any SAE occurring in the course of the study, any changes in the protocol andSubject Information / Informed Consent and study related documents and asks to beinformed of study completion and / or withdrawal reasons. The committee also asksto be provided a copy of the final report. We have noted that neither you nor any ofyour proposed study team members were not present during the decision makingprocedures of the Ethics Committee.
It is confirmed that our Ethics Committee is constituted and function as per ICH-GCPguidelines and Good clinical practice guidelines issued by the Central drug standardscontrol organization and ethical guidelines for Biomedical Research on humansubjects, issued by the Indian Council of Medical Research.
Yours sincerely,
,/'/J ~ ~tr(j\fJJ;IVJ ~ ~ \(> t\\
Member ecretarv/Authorlzed signatory as per working procedure Ethics
Committee.
Member SecretaryEthics Committee
Ape". Hospital, Bilaspur (C.G.)
Seepat Road,BiJaspur495006Chhatisgarh,Phone: 07752-248300-05,414805Fax: 07752-409999EmergencyIAmbulance:1066/243310/414514