Committee for Evaluation of Protocols for Clinical Research

Transcription

1 Ref: Protocol CANVAS Date: January 25, 2010 Vice Medical Dear Dr. Arpan Dev Bhattacharyya, With reference to study A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 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 DIA3008 Final Version Release Date: 16-September Investigator s Brochure Edition Number : Edition 6, replacing Edition 5 dated 06 April 2009 Release Date : 2 June Copy of e-crf Version 05 Dated : 26-Aug 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

2 Tel: E mail: clinicom@gmail.com Vice Medical 6. Patient Materials DIA 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 Study Card DIA-3008-INE14 2 Jul Study Participation Factsheet DIA-3008-INE15 3 Sep Appointment Reminder Card DIA-3008-INE17 2 Jul Visit Guide DIA-3008-INE18 3 Sep Treatment Tear pad DIA-3008-INE20 2 Jul Study Diary DIA-3008-INE26 2 Sep Be Active Stay Active DIA-3008-INE27 2 Jul Exercising Safely with Diabetes DIA-3008-INE28 2 Jul Learning about low blood sugar DIA-3008-INE29 2 Jul Adding Physical activity to your day DIA-3008-INE30 2 Jul Masterful Meal Plan DIA-3008-INE31 2 Jul Planning Ahead for Good Diabetes Management DIA-3008-INE32 2 Jul-09 How to Use your Food & Activity Log DIA-3008-INE33 2 Jul My Diabetes Management Plan DIA-3008-INE34 2 Jul The Pedometer DIA-3008-INE35 2 Jul Diet and exercise counseling DIA-3008-INE36 2 Jul Choosing Health Foods DIA-3008-INE37 2 Jul Collecting Your Urine Sample DIA-3008-INE53 1 Jul CV AE Reporting for Phase 3 Development Program 8. SUA GAP Pack Dated 28-Sep ICD Translation Certificate, dated 07-Dec Principal Investigator s Undertaking & CVs 11. Clinical Trial Permission from DCGI 12. Insurance / Indemnity Letter 13. Draft CTA

3 Vice Medical The following members of CLINICOM were present at the meeting held on January 21, 2010 at 4.30 pm at Clinicom, No. 7, 17 th A Cross, Malleswaram West, Bangalore Mr V V Raghavan, ( & Expert) Chairman 2. Dr P H Prasad, (Medical ), Vice 3. Ms Vidya Sury, (Homemaker), 4. Ms Chetana Sudhir (), Member 5. Ms Renu Srinivasan,( ), Member 6., (), Member 7. Dr S Krishnamurthy, and Member 8., (), 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., (), Member 2. Dr Nandini Mundkur, (Pediatric ), 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.

4 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, Vice Medical Vidya Sury January 25, 2010

5 INVOICE Vice Medical Invoice no.0196a/clinicom/ Date: January 25, 2010 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 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial: CANagliflozin CardioVascular Assessment Study) (Rupees Ten Thousand Only) Note: Cheque/DD may please be made in favor of CLINICOM payable at Bangalore Yours sincerely, Rs.10, Authorized Signatory Dated: January 25, 2010

6 Date: January 14, 2010 Vice Medical AGENDA The following protocol will be discussed during our meeting on Friday January 15, 2010, at 4.30 pm at Clinicom, No.7, 17 th A Cross, Malleswaram West, Bangalore A Randomized, Multicenter, Double-Blind, Parallel, Placebo- Controlled Study of the Effects of JNJ on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial: CANagliflozin CardioVascular Assessment Study) Received from Cordially yours, For Vidya Sury Date: January 14, 2010

7 Vice Medical Minutes of the meeting held on Friday January 15, 2010 at 4.30 pm at Clinicom, No.7, 17 th A Cross, Malleswaram West, Bangalore We discussed the Protocol No.: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial:CANagliflozin CardioVascular Assessment Study) received from: The following members of CLINICOM were present 1. Mr V V Raghavan, ( & Expert) Chairman 2. Dr P H Prasad, (Medical ), Vice 3. Ms Vidya Sury, (Homemaker), 4. Ms Chetana Sudhir (), Member 5. Ms Renu Srinivasan,( ), Member 6., (), Member 7. Dr S Krishnamurthy, and Member 8., (), 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., (), Member 2. Dr Nandini Mundkur, (Pediatric ), Member No observations were made. We hereby approve the above-referred study in its presented form. Cordially yours, Vidya Sury Date: January 15, 2010