committee for evaluation of protocols for clinical … · committee for evaluation of protocols for...

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: Protocol CANVAS Date: January 25, 2010 Dr.Arpan Dev Bhattacharyya. Lotus Diagnostic Centre. #493 CMH road . Indiranagar. Bengaluru 38

Dear Dr. Arpan Dev Bhattacharyya, With reference to study “A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial: CANagliflozin CardioVascular Assessment Study) CLINICOM met on Thursday January 22, 2010 at 4.30 pm to review and discuss the following documents. 1. Clinical Study CANVAS Protocol 28431754DIA3008 Final Version Release

Date: 16-September -2009

2. Investigator’s Brochure Edition Number : Edition 6, replacing Edition 5 dated 06 April 2009 Release Date : 2 June 2009

3. Copy of e-CRF Version 05 Dated : 26-Aug-2009

4. Patient Information and Informed Consent Documents Version Dated :

20-Sep-2009

i. English ii. Hindi iii. Telugu iv. Tamil v. Kannada

5. Infomed Consent Documents for Optional DNA Research Version Dated :

10-Nov-2009

i. English ii. Hindi iii. Telugu iv. Tamil v. Kannada





6. Patient Materials DIA -3008

Sl.No. Document Name Document No. Version

no. Version

date 1 Patient Flyer DIA-3008-INE01 2 Jul-09 2 Poster DIA-3008-INE02 2 Jul-09 3 Patient Mailer DIA-3008-INE04 2 Jul-09 4 Welcome letter DIA-3008-INE06 2 Jul-09 5 Thank you letter - Initial DIA-3008-INE07 2 Jul-09 6 Thank you letter - Final DIA-3008-INE08 2 Jul-09 7 News ad DIA-3008-INE09 2 Jul-09

8 Radio Ad script DIA-3008-INE10 2 Jul-09 9 Web ad DIA-3008-INE11 2 Jul-09 10 Study Card DIA-3008-INE14 2 Jul-09 11 Study Participation Factsheet DIA-3008-INE15 3 Sep-09 12 Appointment Reminder Card DIA-3008-INE17 2 Jul-09

13 Visit Guide DIA-3008-INE18 3 Sep-09 14 Treatment Tear pad DIA-3008-INE20 2 Jul-09 15 Study Diary DIA-3008-INE26 2 Sep-09 16 Be Active Stay Active DIA-3008-INE27 2 Jul-09 17 Exercising Safely with Diabetes DIA-3008-INE28 2 Jul-09 18 Learning about low blood sugar DIA-3008-INE29 2 Jul-09

19 Adding Physical activity to your day DIA-3008-INE30 2 Jul-09

20 Masterful Meal Plan DIA-3008-INE31 2 Jul-09

21 Planning Ahead for Good Diabetes Management DIA-3008-INE32 2 Jul-09

22 How to Use your Food & Activity Log DIA-3008-INE33 2 Jul-09

23 My Diabetes Management Plan DIA-3008-INE34 2 Jul-09 24 The Pedometer DIA-3008-INE35 2 Jul-09 25 Diet and exercise counseling DIA-3008-INE36 2 Jul-09 26 Choosing Health Foods DIA-3008-INE37 2 Jul-09 27 Collecting Your Urine Sample DIA-3008-INE53 1 Jul-09

7. CV AE Reporting for Phase 3 Development Program 8. SUA GAP Pack Dated 28-Sep-2009 9. ICD Translation Certificate, dated 07-Dec-2009 10. Principal Investigator’s Undertaking & CVs 11. Clinical Trial Permission from DCGI 12. Insurance / Indemnity Letter 13. Draft CTA





The following members of CLINICOM were present at the meeting held on January 21, 2010 at 4.30 pm at Clinicom, No. 7, 17th ‘A’ Cross, Malleswaram West, Bangalore – 560055

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

Expert) Chairman 2. Dr P H Prasad, (Medical Scientist), Vice Chairperson 3. Ms Vidya Sury, (Homemaker), Member Secretary 4. Ms Chetana Sudhir (Social Worker), Member 5. Ms Renu Srinivasan,(Social Worker/Educationist), Member 6. Mr Arun Madhavan, (Theologian), Member 7. Dr S Krishnamurthy, Legal Expert and Member 8. Ms Vidhya Nuti, (Legal Expert), 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. Dr K Venkatesan, (Scientist), Member 2. Dr Nandini Mundkur, (Pediatric Consultant), Member

We hereby approve the above-referred study document in its presented form. This approval is valid for the entire duration of 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. 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:

- Any changes to or deviations to the protocol approved by CLINICOM that you might implement to eliminate hazards to the trial subjects.

- All serious adverse events - 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,

Vidya Sury Member Secretary January 25, 2010





INVOICE

Invoice no.0196A/Clinicom/2009-2010

Date: January 25, 2010

Dr.Arpan Dev Bhattacharyya. Lotus Diagnostic Centre. #493 CMH road . Indiranagar. Bengaluru 38

Description:

Being Charges Towards Approval of the following study documents

approved on January 21, 2010:

“A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial: CANagliflozin CardioVascular Assessment Study)

Rs.10,000.00 (Rupees Ten Thousand Only)

Note: Cheque/DD may please be made in favor of

CLINICOM payable at Bangalore

Yours sincerely, For CLINICOM,

_________________

Authorized Signatory Dated: January 25, 2010





Date: January 14, 2010

AGENDA

The following protocol will be discussed during our meeting on Friday January 15, 2010, at 4.30 pm at Clinicom, No.7, 17th ‘A’ Cross, Malleswaram West, Bangalore 560055 “A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial: CANagliflozin CardioVascular Assessment Study)

Received from Dr.Arpan Dev Bhattacharyya. Lotus Diagnostic Centre. #493 CMH road . Indiranagar. Bengaluru 38

Cordially yours, For CLINICOM,

For Vidya Sury Member Secretary Date: January 14, 2010





Minutes of the meeting held on Friday January 15, 2010 at 4.30 pm at Clinicom, No.7, 17th ‘A’ Cross, Malleswaram West, Bangalore 560055 We discussed the Protocol No.: “A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial:CANagliflozin CardioVascular Assessment Study) received from: Dr.Arpan Dev Bhattacharyya. Lotus Diagnostic Centre. #493 CMH road . Indiranagar. Bengaluru 38 The following members of CLINICOM were present

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

Expert) Chairman 2. Dr P H Prasad, (Medical Scientist), Vice Chairperson 3. Ms Vidya Sury, (Homemaker), Member Secretary 4. Ms Chetana Sudhir (Social Worker), Member 5. Ms Renu Srinivasan,(Social Worker/Educationist), Member 6. Mr Arun Madhavan, (Theologian), Member 7. Dr S Krishnamurthy, Legal Expert and Member 8. Ms Vidhya Nuti, (Legal Expert), 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. Dr K Venkatesan, (Scientist), Member 2. Dr Nandini Mundkur, (Pediatric Consultant), Member

No observations were made. We hereby approve the above-referred study in its presented form. Cordially yours,

For CLINICOM,

Vidya Sury Member Secretary Date: January 15, 2010