2023-06-02T04:50:11
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).
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