Format of informed consent form for Subjects participating in a clinical investigation Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 193 of 248 Informed Consent form to participate in a clinical investigation Clinical investigation Title: Clinical investigation Number: Subject's Initials:................................... Subject's Name:........................... Date of Birth/ Age:................................ Gender:...................................... Address of the Subject:........................ Qualification:.................................... Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the Subject:.................................... Name and address of the nominee(s) and his relation to the Subject............................ (for the purpose of compensation in case of clinical investigation related death). Place initial box (Subject) (i) I confirm that I have read and understood the information sheet dated.........................for the above clinical investigation and have had the opportunity to ask questions. [ ] (ii) I understand that my participation in the clinical investigation 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 investigation, 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 clinical investigation and any further research that may be conducted in relation to it, even if I withdraw from the clinical investigation. 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 [ ] Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 194 of 248 arise from this clinical investigation provided such a use is only for scientific purpose(s). (v) I agree to take part in the above clinical investigation. [ ] (vi) I understand that in case of an injury occurring during the clinical investigation [ ] (vii) I understand that in the event of an investigation related injury or death [ ] Signature (or Thumb impression) of the Subject/Legally Acceptable Representatives.............................................................................. Date:........../........../.......... Signatory's Name:............................................................................. Signature of the Investigator:.................................................. Contact Details (Telephone Number/mobile) on which Subject may contact: Date:........../........../.......... Clinical investigation Investigator's Name: Signature of the Witness.......................... Name of the Witness:.................................... Address and contact details of the Witness:......................................... Copy of the Patient Information Sheet and duly filled Informed Consent Form shall be handed over to the Subject or his/her attendant).