committee for evaluation of protocols for clinical research · 2011-06-12 · ms. chetana sudhir m...

Committee for Evaluation of Protocols for Clinical Research

“Bhooma”, No.7 , 17 A Cross , Malleswaram West , Bangalore 560 055

Tel:+91-80-23342471 E mail: [email protected]

Chairperson Mr. V V Raghavan M.Sc. Clinical Trials Expert & Pharmaceutical Technologist Vice Chairperson Dr. P H Prasad MBBS, FCCP Medical Scientist Member Secretary Ms. Vidya Sury B Sc, MBA, Dip.T&D Home Maker Members: Dr. S Krishnamurthy LL.M, Ph.D, LL.D,D.Lit Legal Expert Ms Vidhya Nuti BSc, LLB, PGDIPRL Legal Expert Dr K Venkatesan M A, Ph D Scientist Dr.Nandini Mundkur M D (Paed), MAMC Paediatric Consultant Mr Arun Madhavan B Com, MBA Theologian Ms.Renu Srinivasan M A, B.Ed Social Worker/Educationist Ms. Chetana Sudhir M A, B.Ed Social Worker

Ref: Study No. BAY 12-8039/11643 Date: May 20, 2010 Our ref: 029/5.5.10 Dr. Dhiren N. Patel Shrey Hospital, IRL Research (P) Ltd, Near AMCO Bank, Punjabi Hall lane, Navrangpura, Ahmedabad- 380009 Dear Dr. Dhiren N. Patel, With reference to the Study no. BAY 12-8039/11643 titled A randomized, double-blind, multicenter trial to evaluate the safety and efficacy of sequential (intravenous, oral) moxifloxacin versus comparator in pediatric subjects with complicated intra-abdominal infection, CLINICOM met on Wednesday, May 5, 2010 at 4.30 pm to review and discuss the following documents received vide your letter dated April 17, 2010:

Sl. no.

Document Details

1.

Protocol of Study Title: A randomized, double-blind, multicenter trial to evaluate the safety and efficacy of sequential (intravenous, oral) moxifloxacin versus comparator in pediatric subjects with complicated intra-abdominal infection. Protocol No: BAY 12-8039/11643, Version: 1, Dated: 23 Sep 2009 Controlled Copy Number: INDIA 028 to INDIA 036

2. Investigators Brochure: Version: 13.0, Dated: 01 Oct 2009, Controlled Copy Number: INDIA 028 to INDIA 036

3.

Pediatric Study Subject Assent Form, Group 12-17 years of age English - Version 1.0 dated 01-Mar-2010 for Shrey Hospital customized from India Specific Version 1.0 dated 10-Feb-2010 adapted from Final Master Version 1.0 dated 30-Oct-2009 Hindi - Version 1.0 dated 30-Mar-2010 for Shrey Hospital translated from English - Version 1.0 dated 01-Mar-2010 for Shrey Hospital customized from India Specific Version 1.0 dated 10-Feb-2010 adapted from Final Master Version 1.0 dated 30-Oct-2009 Gujarati – Version 1.0 dated 30-Mar-2010 for Shrey Hospital translated from English - Version 1.0 dated 01-Mar-2010 for Shrey Hospital customized from India Specific Version 1.0 dated 10-Feb-2010 adapted from Final





Master Version 1.0 dated 30-Oct-2009

4.

Pediatric Subject Information and Consent Form, Group 12-17 years of age English – Version 1.0 dated 01-Mar-2010 for Shrey Hospital customized from India Specific Version 1.0 dated 10-Feb-2010 adapted from Final Master Version 2.0 dated 19-Nov-2009 Hindi – Version 1.0 dated 30-Mar-2010 for Shrey Hospital translated from English - Version 1.0 dated 01-Mar-2010 for Shrey Hospital customized from India Specific Version 1.0 dated 10-Feb-2010 adapted from Final Master Version 2.0 dated 19-Nov-2009 Gujarati – Version 1.0 dated 30-Mar-2010 for Shrey Hospital translated from English - Version 1.0 dated 01-Mar-2010 for Shrey Hospital customized from India Specific Version 1.0 dated 10-Feb-2010 adapted from Final Master Version 2.0 dated 19-Nov-2009

5.

Patient Recruitment Materials

Brochure - 1030091200 English, Hindi and Gujarati.

Diary Card English - Version 1.0 dated, 30 Oct 2009 Hindi - Version 1.0 dated, 30 Oct 2009 Gujarati - Version 1.0 dated 30 Oct-2009 Poster - 1030091200

English, Hindi and Gujarati.

Referral Card - 1030091200 English, Hindi and Gujarati.

Reminder Card - 1030091200 English, Hindi and Gujarati.

Study Flowchart - 1030091200 English, Hindi and Gujarati.

6. Bayer Protocol 11643 Paper- White Paper 1.0 final_2009-12-03_signed

7. European Medicines Agency (EMEA): Opinion of the Paediatric committee on the agreement of a Paediatric Investigation plan and a deferral and a





waiver – EMEA/PDCO/163156/2009, EMEA-000288-PIP01-08

8. Current CV of the Principal Investigator Dated: 11 Mar 2010

9. Undertaking by the Investigator: Dated: 26 Feb 2010

10. Insurance certificate No.: LP00000760000102, Dated: 06 Jan 2010

This is only a conditional approval. Kindly submit a copy of the DCGI approval letter before commencing any study related activity. Also let us know the CTRI registration number for the study.

Please note that CLINICOM is organized and operates according to the requirements of the ICH-GCP, Indian Council of Medical Research and Schedule Y. We confirm that neither you nor your study team members participated in the deliberations of the ethics committee and did not vote on the proposal for this study. The following members of CLINICOM were present at the meeting held on Wednesday, May 5, 2010 at 4.30 pm. at Clinicom, No. 7, 17th ‘A’ Cross, Malleswaram West, Bangalore – 560055

The following members of CLINICOM were present

1. Dr. P H Prasad, (Medical Scientist), Vice Chairperson 2. Ms. Vidya Sury, (Homemaker), Member Secretary 3. Dr. Nandini Mundkur, (Pediatric Consultant), Member 4. Dr. K Venkatesan, (Scientist), Member 5. Ms. Vidhya Nuti, (Legal Expert), Member 6. Dr. S Krishnamurthy, (Legal Expert), Member 7. Mr. Arun Madhavan, (Theologian), Member

The following members did not attend the meeting. However they have reviewed the protocol documents and have no objection to the conduct of the study.

1. Mr V V Raghavan, (Pharmaceutical Technologist & Clinical Trials

Expert) Chairman 2. Ms. Chetana Sudhir, (Social Worker), Member 3. Ms. Renu Srinivasan, (Social Worker / Educationist), Member

Please follow the requirements given below for this study:

Do not implement any deviation from, or change to, the protocol approved by this ethics committee without the prior written approval of this ethics committee.





Deviations/ changes to the approved protocol may be implemented 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)].

Promptly report to CLINICOM, the following:

1. Any changes to or deviations to the protocol approved by CLINICOM

that you might implement to eliminate hazards to the trial subjects. 2. All serious adverse events 3. New information that may affect adversely the safety of the subjects

or the conduct of the trial. Please submit the status report of the study to CLINICOM at 6-month intervals. Also, provide us with a copy of the final study completion report. Cordially yours,

For CLINICOM,

V V Raghavan Chairman Date: May 20, 2010

committee for evaluation of protocols for clinical research · 2011-06-12 · ms. chetana sudhir m...

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