s*-* ommittee (IEC) E v Independent Ethics C Regd. No. 1433 / 1999 G.B.B.S.D. Chairman Dr. R. D. Lele FRCP (Tel. No.: O22-22O2 1e17) Member Secretaty Dr. Raakhi Tripathi MD (Tel. No.: O22 - 2301 2223\ Associate Member Secretary Dr. R. B. Pandit MD FICP (Tel. No.: 022-2765 7025\ Adddress for Correspondence : Dept. ol Clinical Pharmacology BYL Nair llospital and TN Medical College, Old RMO Building,Sth Floor, Bombay Central, Mumbai-400 008. Telefax : O22-23012223 E-Mail : [email protected]Date: 13tr Nov 2009 Annex 3 AF/03/01-soP06/01 Page 1 of5 Members : Rev. Jonah David, Dr. Mrs. sandhya Kamat MD, Dr. sandeep Bavdekar MD Dr. R. K. sharma Mq Dr. U. M. Thafte MD, phD flr D N llnacanillq ll A ilc t\lrrr{a\/aarre{anrtl A lrelA, n- r.-^ tt^-^L^- INDEPENDENT ETHICS COMMITTEE PROJECT APPROVAL LETTER Address of Ethics Commiftee Dept of Clinical Pharmacology TNMC & BYL Nair Charitable Hospital Dr. A.L. Nair Road, Mumbai Central, Mumbai 400 009. Principal Investigator: - Dr.Usha M Agarwal Haematology Center, 2nd floor, Ghamat Lodge, 8041A, Dr.B.Ambedkar Road, Above ING Vyasya Bank, Dadar TT, Mumbai 400 014 Ciinicai trial protocol title: protoco trial of ofatumumab-chlorambucil combination vs. Chlorambucil Monotherapy in previously untreated patients with chronic Lymphocytic Leukemia (rBcl}glll\ The Independent Ethics Committee tral revGweO tfre following documents submitted foi the above _ mentioned clinical study Name of document Protocol No. OMB 11091I Oat written Informed consent Form dated 3l't Aug 2009 English version 04.01 written Informed consent Form dated 3l't Aug 2009 Hildi version 04.01 translated from Eng to Hindi on246 Sep 2009 written Informed consenr Form dated 3l't Aug 2009 Hindi version 04.01 back_ translated from Hindi ro Eng on 24h Sep 2009 Translation certificate dated 29n Sep 2009 from valuepoint knowledgeworks pvt. Ltd for translation of ICF version 04.01 from nng to Hindi certificate dated2gh Sep 2009 from valuepointlnowledgeworks pvt. Ltd for translation of ICF version 04.01 from Eng to Hindi certificate dated296 Sep 2009 from Valuepoint knowledgeworks pra. Ltd for back- translation of ICF version 04.01 from Hindi to Eng written Informed consent Form dated 3 r't Aug 2009 Marathi version 04.01 written Informed consent Form dated 3 r't Aug 2009 Hindi version 04.01 back- translated fiom Marathi to Eng on24e Sep 2009 certificate dated29rt Sep 2009 from valuipoint knowledgeworks pvt. Ltd for translation of ICF version 04.01 from Eng to Marathi certificate dated2gh sep 2009 from valiepoint knowledgeworks pvt. Ltd for back- translation of ICF version 04.01 from Marathi to En
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Independent Ethics Committee (IEC) · Above ING Vyasya Bank, Dadar TT, Mumbai 400 014 Ciinicai trial protocol title: protoco trial of ofatumumab-chlorambucil combination vs. Chlorambucil
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Members : Rev. Jonah David, Dr. Mrs. sandhya Kamat MD, Dr. sandeep Bavdekar MD Dr. R. K. sharma Mq Dr. U. M. Thafte MD, phDflr D N llnacanillq ll A ilc t\lrrr{a\/aarre{anrtl A lrelA, n- r.-^ tt^-^L^-
INDEPENDENT ETHICS COMMITTEEPROJECT APPROVAL LETTER
Address of Ethics Commiftee Dept of Clinical PharmacologyTNMC & BYL Nair Charitable HospitalDr. A.L. Nair Road,Mumbai Central, Mumbai 400 009.
Principal Investigator: - Dr.Usha M AgarwalHaematology Center, 2nd floor,Ghamat Lodge, 8041A, Dr.B.Ambedkar Road,Above ING Vyasya Bank,Dadar TT, Mumbai 400 014
Ciinicai trial protocol title: protocotrial of ofatumumab-chlorambucil combination vs. Chlorambucil Monotherapy in previouslyuntreated patients with chronic Lymphocytic Leukemia (rBcl}glll\The Independent Ethics Committee tral revGweO tfre following documents submitted foi the above _mentioned clinical study
Name of document
Protocol No. OMB 11091I Oatwritten Informed consent Form dated 3l't Aug 2009 English version 04.01written Informed consent Form dated 3l't Aug 2009 Hildi version 04.01 translatedfrom Eng to Hindi on246 Sep 2009written Informed consenr Form dated 3l't Aug 2009 Hindi version 04.01 back_translated from Hindi ro Eng on 24h Sep 2009Translation certificate dated 29n Sep 2009 from valuepoint knowledgeworks pvt.Ltd for translation of ICF version 04.01 from nng to Hindicertificate dated2gh Sep 2009 from valuepointlnowledgeworks pvt. Ltd fortranslation of ICF version 04.01 from Eng to Hindicertificate dated296 Sep 2009 from Valuepoint knowledgeworks pra. Ltd for back-translation of ICF version 04.01 from Hindi to Engwritten Informed consent Form dated 3 r't Aug 2009 Marathi version 04.01written Informed consent Form dated 3 r't Aug 2009 Hindi version 04.01 back-translated fiom Marathi to Eng on24e Sep 2009certificate dated29rt Sep 2009 from valuipoint knowledgeworks pvt. Ltd fortranslation of ICF version 04.01 from Eng to Marathicertificate dated2gh sep 2009 from valiepoint knowledgeworks pvt. Ltd for back-translation of ICF version 04.01 from Marathi to En
12. written Informed consent Form dated 31't Aug 2009 Gujarati versi,on 04ol13. written Informed consent Form dated 31't Aug 2009 Gujarati version 04.01 back-
translated from Gujarati to Eng on24h Sep 200914. Certificate dated 29s Sep 2009 from Valuepoint knowledgeworks pvt. Ltd for
translation of ICF version 04.01 from Eng to Gujarati15. certificate dated 29b Sep 2009 from valuepoint knowledgeworks pvt. Ltd for back-
16.
17.18.
19.20.21.22.25.24.25.26.
translation of ICF version 04.01 from Gujarati to EngOfatumumab Investigator's Brochure version number 0l dated I lft Feb 2009DCGI approval letter dated 8tr Sep 2009lnsurance Certificate dated 10rt Sep 2009:- Policy number: OG-10-1901-3306-00000006, Effective date-7ft Aug 2009, Expiration date- 31't Dec 2009ABPI Compensation Guidelines (Eng, Hindi, Marathi & Gujmati)Ofatumumab INDSRs from the IB cut-off date (14-Nov-08) to 8-Sep-09Final Clinical Trial Agreement dated l9e June 2009Final trial budget as per letter dated I lft Sep 2009ClinicalTrials.Gov registration number - NCT00748 I 89Site profileConfirmatory note from PI dated I le Sep 2009Training certificates for Dr. Usha M. Agarwal, Dr. Mohan Agarwal, Dr. prajaktaBhogate & Dr. Shonali Rathi
27. Approval letters from other trial sites. Approval letter dated 5h Aug 2009 from Tata Memorial Hospital Human Ethics
Committee to Dr. Manju Sengar. Approval letter dated 6s Mar 2009 from Poona Medical Research Foundation Ethics
Committee to Dr. Minish Jain. Approval letter dated2"d June 2009 from Ethics Committee of The Heart Care
Clinic to Dr. Bhavin Shah. Approval letter dated 12tr June 2009 from Ethics Committee of Kidwai Memorial
Institute of Oncology to Dr. K. Govind Babu28. Blinded and Unblinded PSRIs for the following duration:o l-Nov'08 to 31-Jan-09o l-Feb-O9 to 30-Apr-09
Page 2 of5
The following Ofatumumab INDSRs from the IB cut-off date (14-Nov-08) to 8-Sep-09 have been notified to the
"The Independent Ethics Committee hereby confirm that the composition and operating procedures ofIndependent Ethics Committee Mumbai, are as per Amended Schedule Y (20th January 2005) and ICH-GCpguidelines"
Page 4 of 5
The approval is valid from 13th November 2009 to 12th November 2010 and renewal of this clinical project issubject to review of "Annual Study Report" submitted to this Ethics committee by the Investigator.
The research proponenrequire the following:
t *ti#tff[:
events those are either serious or unexpected to be reported within 7 working days
]. the progress report to be submitted to the IEC at least annually3'upon completion/premature termination of the study, a fin'al study status report includingsummaxy of results needs to be submitted to the IEC.4'All protocol deviations/changes in the protocol must be informed to the IEC in writing andnotification / approval from the IEC must be_taken. No
"rtung"-io the protocol (amendment)
must be implemented without approval of the IEC5. The PI must promptly report thi lollowing to the IEC:a) Any 'new information' acquired during the course of the trial that may adversely affectthe safety ofthe subjectb) Any 'change' in the protocol that will increase the existing risk /subject the researchparticipants to new risks during the course of the trial
In the above circumstances measures taken by the PI to protect the research participants andeliminate hazards must be specified
A maximum of 8 patients will be screened for the above mentioned trial
A maximum of 6 patients will be enrolled in the above mentioned trial