UNDERTAKING BY THE INVESTIGATOR

1.Principal investigators
Full Name: Dr. SANDEEP VITTHALRAO BHAPKAR
Qualification: M.B.B.S.
Resident Doctor,
Dept. of Pharmacology
GMC, Aurangabad.
Mobile No. +91 8149149936
Maharashtra Medical Council Registration Number: 2012/05/1210
Full Name: Dr. K.C. CHANDALIYA
M.B.B.S., M.D.
Associate Professor,
Dept. of Pharmacology,
GMC, Aurangabad.
Mobile No. +91 9423149649
2. Trial site:
Government Medical College & Hospital, Aurangabad
3. Ethical Committee responsible for continuous study review and approval:
Institutional ethical committee, Government Medical College & Hospital,
Aurangabad
4. Members of the research team
Principal Investigator:
Dr. SANDEEP VITTHALRAO BHAPKAR
M.B.B.S.,
Resident Doctor,
Dept. of Pharmacology
GMC, Aurangabad.
Mobile No. +91 8149149936
Post-graduate guide:
Dr. K.C. CHANDALIYA
M.B.B.S., M.D.
Associate Professor,
Dept. of Pharmacology,
GMC, Aurangabad
Mobile No. +91 9423149649
5. Protocol title and study number:

SOD/COPD/01/2014

An Interventional, Randomized, Placebo Controlled, Parallel, Single blind Efficacy Study of Oral
Superoxide dismutase preparation as an add on therapy on Respiratory Health Status in
Patients with Chronic Obstructive Pulmonary Disease (COPD)

6. Commitments
a. I have reviewed the clinical protocol and agree that it contains all the necessary information to
conduct the study.
b. I will not begin the study until all necessary Ethics Committee and regulatory approvals have
been obtained.
c. I agree to conduct the study in accordance with the current protocol. I will not implement any
deviation form or changes of the protocol without prior review and documented approval from the
ethics committee of the amendment, except where necessary to eliminate an immediate hazard to
the study subjects or when the changes involved are only logistical and administrative in nature.
d. I agree to personally conduct and supervise the study at my site
e. I agree to ensure that the requirements relating to obtaining informed consent and ethics
committee review and approval specified on the guidelines are met.
f. I have read and understood the information in the investigators brochure.
g. I agree to ensure all associates, collogues and employees assisting in conduct of study are suitably
qualified and experienced and they have been informed about their obligations in meeting their
commitments in the study.
h. I agree to maintain adequate and accurate records and make those records available for
audit/inspection by the Ethics Committee or their authorized representative in accordance with
regulatory provisions.
i. I agree to promptly report to the Ethics Committee all changes in the anthropometrical study and
all unanticipated problems involving risks to human being or others.
j. I agree to inform all unexpected serious events to the Ethical Committee within seven days of
their occurrence.
k. I will maintain security and confidentiality of study data.
l. I agree to comply with all other requirements, guidelines and statutory obligations as applicable
to investigators participating in studies.

7. Signature of the Investigator with date: