INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed consent documents 1.1 Essential elements: 1. Statement that the study involves research and explanation of the purpose of the research 2. Expected duration of the Subject's participation 3. Description of the procedures to be followed, including all invasive procedures 4. Description of any reasonably foreseeable risks or discomforts to the Subject 5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected, Subject should be made aware of this. 6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject. 7. Statement describing the extent to which confidentiality of records identifying the Subject will be maintained and who will have access to Subject's medical records 8. Clinical investigation treatment schedule(s) and the probability for random assignment to each treatment (for randomised clinical investigation) 9. Statement describing the financial compensation and medical management as under:— (a) In case of an injury occurring to the subject during the clinical investigation, free medical management shall be given as long as required or till such time it is established that the injury is not related to the clinical investigation, whichever is earlier. (b) In the event of an investigation related injury or death, the Sponsor or his representative, whoever has obtained permission from the Central Licensing Authority for conduct of the clinical Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 192 of 248 investigation, shall provide financial compensation for the injury or death. 10. An explanation about whom to contact for clinical investigation related queries, rights of Subjects and in the event of any injury. 11.The anticipated prorated payment, if any, to the Subject for participating in the clinical investigation. 12. Subject's responsibilities on participation in the clinical investigation. 13. Statement that participation is voluntary, that the Subject can withdraw from the clinical investigation at any time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise entitled. 14. Statement that there is a possibility of failure of investigational medical device to provide intended therapeutic effect. 15. Any other pertinent information.