spandan-independent ethics committ e · 2013. 6. 13. · may 2013 was reviewed by deputy...

Spandan-Independent Ethics Committ e Spandan . lEe

8-5. Siddhi Sarjan Appt ., Nr. Seema Hall , Anandnagar, Satellite, Ahmedabad-380 015. E-mail : spandaniecrg'qmail .com

Date: 13th May 2013 Ref No: SlEC/ALl05-13/002

To,

Dr. Ronak Shah,

Poojan Multispeciality Hospital,

1st Floor, Navnidhi Avenue, Gurukul Road,

Subhash Chowk, Memnagar

Ahmedabad-380052, Gujarat, India

Dear Dr. Ronak Shah,

Subject: Review and approval of Protocol entitled "A Multi-center, Prospective, Open-label ,

Randomized, Active-Controlled, Parallel-Group Clinical Study of Safety and Efficacy of

Diclofenac Dieth ylamine Gel with Capsaicin, Methyl Salicylate and Menthol with Voveran®

Thermagel" (Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol) in

Painful Musculoskeletal Conditions."

Protocol No: ECTSI13/002, Version No. 00; Dated 30 MAR 2013

In response to your letter dated 20-Apr-20 13 for review and approval of above referred clinical

study documents, Spandan - Independent Ethics Committee conducted a meeting for review of

Protocol the meeting was held on Saturday, ll-May-2013, 5:00 pm at B-5 , Siddhi Sarjan Appt. ,

Near Seem a Hall, Anandnagar, Satellite, Ahmedabad - 15 in which the following Quorum of

members was present: .

I. Dr. Gaurav Chhaya - Deputy Chairperson

2. Mr. Mil an Rachh - Pharmaceutical ScientistlMember Secretary

3. Dr. Bhoomika Patel - Pharmacologist

4. Mr. Manish Shah - Lay Person

5. Mrs. Arunaben Shah - Legal Advisor

6. Dr. Gopal Bhatt - Social Scientist

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Following documents, as per the regulatory requirements were reviewed:

Sr. No. Documents Version No. / Date 1. Study Protocol 00/30 MAR 2013

2. Investigator Brochure (Product description) -Informed Consent Form - English , Gujarati,

3. 00/04 APR 2013 Hindi

4. Screening Case Report Form 00/05 APR 2013

5. Case Report Form 00/05 APR 2013

6. Subject Diary 00/05 APR 2013

Protocol Approval and Consent From

7. Investigators, Undertaking by the Investigators, -CV and MRC of Investigators

8. Insurance Certificate -

All of the above documents were reviewed , and conditional approval was given to the study

under consideration. The following suggestions/recommendations for alterations to study

Protocol under consideration were made by Span dan - Independent Ethics Committee members:

1. VAS score to be kept in between 3-8 in inclusion criteria.

2. BP range to be specified for uncontrolled hypertension in exclusion criteria.

3. Urine Pregnancy Test to be include during screening.

4. Calibrator dose strip should be used.

Based on the favorable' opinion given by Spandan - IEC members who participated in the meeting

Spandan - Independent Ethics Committee grants conditional approval to the conduct of the proposed

clinical study at Site of: Dr. Ronak Shah, Poojan Multispeciality Hospital, Ist Floor, Navnidhi

Avenue, Gurukul Road , Subhash Chowk, Memnagar Ahmedabad-380052, Gujarat, India subject to

following conditions of compliance:

I. That the study will be conducted in full compliance to good clinical practice guideline

and applicable regulatory requirements,

ii. The Spandan - IEC shall do a continuing review of the progress of the t ~ial , for which

you will provide periodic updates on the progress of the same as a part of your

responsibility at every 6 months and yearly summary report.

Ill. The Spandan - IEC shall provide, according to the applicable regulatory requirements,

expedited review and approval/favorable opinion on minor change(s) in the trial during

the course of its conduct, ifrequired,

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iv. That no deviation from, or changes in, the protocol would be initiated without written

Spandan - lEC approval/favorable opinion of an appropriate amendment, except when

necessary to eliminate immediate hazards to the subjects or when the change(s) involve

only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone

number(s))

v. That you would promptly report to the Spandan - IEC: (a) deviation from, or changes in,

the protocol to eliminate immediate hazard to the trial subject, (b) changes increasing the

risk to subject and/or significantly affecting the conduct of the trial, (c) all adverse events

including, serious and unexpected, and (d) new information that may adversely affect the

safety of the subjects or the conduct of the trial, and

VI. That the Spandan - IEC would promptly notify in writing the investigator/institution

concerning: (a) its trial related decisions/opinions, (b) the reason for its

decisions/opinions, and (c) procedures for appeal on its decisions/opinions.

VII. That Spandan - IEC shall be submitted a copy of Final Study Report

Best regards, ii _ ~

lv-~ --\ ~\$ ,')

Dr. Gaurav Chhaya, Deputy Chairperson,

Spandan - lEC

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Spandan-Independent Ethics Committee Spandan . lEe

8-5. Siddhi Sarj an Appt.. Nr. Seema Hall. Anandnagar. Satellite, Ahmedabad-380 015. E-mail: s pandan iec@gm a iI.com

Date: 14th May 20 13 Ref No: SIEC/ALl05-13/009

To,

Dr. R ona k Shah,

Poojan Multispeciality Hospital ,

Ist Floor, Navnidhi Avenue, Gurukul Road,

Subhash Chowk, Memnagar

Ahmedabad-380052, Gujarat, India

Dear Dr. Ronak Shah,

Subject: Review and approval of amendment for Protocol entitled "A Multi-center, Prospective,

Open-label, Randomized, Active-Controlled, Parallel-Group Clinical Study of Safety and

Efficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol with

Voveran® Therrnagel" (Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and

Menthol) in Painful Musculoskeletal Conditions."

Protocol No: ECTSIl3/002, Version No. 00; Dated 30 MAR 2013

In response to your letter dated 13-May-20 13 for review and approval of above referred clinical

study amendment, Spandan - Independent Ethics Committee Deputy Chairperson carried out

expedited review for the Protocol amendment.

Protocol amendment no, 0 I dated 13th May 2013 was reviewed by Deputy Chairperson, Dr.

GauravChhaya and given expedited approval for continuation of the study.

Based on the favorable opinion given by Deputy Chairperson, Spandan - IEC grants approval to

the conduct of the proposed clinical study at Site of: Dr. Ronak Shah, Poojan Multispeciality

Hospital, l st Floor, Navnidhi Avenue, Gurukul Road, Subhash Chowk, Memnagar, Ahmedabad

380052, Gujarat, India subject to conditions of compliance as stated in the approval letter dated

13th May 2013, Ref No .: SIEC/ALl05-13/002

Bestre~

C~\\J\ U> \Y Dr. Gaurav Chhaya,

Deputy Chairperson,

Spandan - IEC

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