Annexure III

Informed Consent form

Study Title:
1).Purpose of Trial:
2).Procedures to be followed. :
3).Risks: No risk
4).Benefits:
5).Alternative treatment: NA
6).Confidentiality of the records: The medical records related to this trial will
be maintained in confidentiality
7).If problem develops: this is a questionnaire based study and involves neither
any invasive investigations nor use any sensitive questions. Hence there is no
question of any problem development.
8).Financial considerations: this study do not require any funds
9) Obtaining additional information: Who you can contact during and after the
trial? If you require further information about the trial or your rights, please
feel free to ask any questions you may have.
Please find below contact details of the trial doctor, study staff, Ethics
Committee and Sponsor:
Trial Doctor (Investigator) Name Dr. (Principal investigator)

Phone: +91-
Email:
Name of the Contact person at trial site (Other than PI) : _Mr. Sreenivas Pandula
Address: _Medical Social Worker, Department of Community Medicine
Malla Reddy Institute of Medical Sciences,
Suraram, Hyderabad
Phone No. : _7780310610__
Name of the Ethics Committee Chairperson: Dr. U. Shoba Jagdish Chandra.
Name of the Ethics Committee: Institutional Ethics Committee, MRIMS
Address: Department of pharmacology, Block 1, 4th floor, MRIMS
Phone No.: 9398681689/7989114154
Name of the Sponsor: NA
10) Basis of participation.
You are free to withdraw your consent to participate in this trial at any time
without giving any reasons.
Subject’s Name: ____________________________________
Subject’s Initials:
Screening No. :[__][__][__][__][__]
Subject No. : [__][__][E][__][__]
Date of Birth:[__][__] [__][__] [__][__]
Age:[__][__]yrs (in completed years)
Gender: [__] (M/F)Telephone No: ________________________
Address of the subject: ___________________________________________________________

Qualification: __________________
Occupation(Tick(✓) the appropriate selection below):
Student( ) or Self-Employed( ) or Service( ) or Housewife( ) or Others( )
Annual Income of the subject: Rs. ___________
Nominee details (For the purpose of compensation in case of trial related death):
Nominee’s Name: ________________________
Nominee’s relation with the subject: _______________________
Address of the Nominee: _________________________________________________________
____________________________________________________________________________
11) Consent .
Please initial box
Subject
(i) I confirm that I have read and understood the information. [ ] Sheet dated
___________ for the above study and have had the opportunity to ask questions.
(ii) I understand that my participation in the study is voluntary and [ ] that I am
free to withdraw at any time, without giving any reason, without my medical care
or legal rights being affected.
(iii) I understand that the Sponsor of the clinical trial, others working on the
Sponsor's behalf, the Ethics Committee and the regulatory authorities will not
need my permission to look at my health records both in respect of the current
study and any further research that may be conducted in relation to it, even if I
withdraw from the trial.
I agree to this access. However, I understand that my identity will not be revealed
in any information released to third parties or published. [ ]
(iv) I agree not to restrict the use of any data or results that arise from this
study provided such a use is only for scientific purposes [ ]
(v) I agree to take part in the above study. [ ]

Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:

Date: _____/ ____ /
Signatory’s Name: __________________________________________________
Signature of the Investigator: _____________ Date: ____ / ____ /
Study Investigator’s Name: ___ ___________________
Signature of the Witness ______________________________ Date: ____ / ____ /
Name of the Witness:________________________
Note: Copy of the Patient Information Sheet and duly filled Informed Consent Form
shall be handed over to the subject his or her attendant.