Informed consent documentation

1)subject Arrival time to site
2)To whom sub met
3)Sub was examined by Prinicipal Investigator
PI checked Medical History,Past History must be recorded.
4)PI felt that he was suitable for Particular Study.He has explained all the study related procedures,Study Details,Benifits,Risks of the Study.
5)Note the Version No xxx
Language ?
of ICF given.
6)Give ample time to decide to participate or not
7)Any quries raised by the patient for that what are the answers given by the PI
must be recorded in the IC docmentation.

8)Then take SUB Consent if he is able
9)If the Sub is unable to give consent take LAR. here note the relationship to the sub
Ex:If the sub is father Then LAR has write SON at the Relationship to the sub.
10)If both are illeterates then Take Impartial witness taken
These are documented.

Give one copy to Sub
Note:If a Patient Sign in Telugu ICF When Sub keeps Consent in English PI Add a comment:-Sub is comfortable in signing in English.

definitions of ICH-GCP alone to substantiate each of the roles of an impartial witness and a LAR.1.26 Impartial WitnessA person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
1.37 Legally Acceptable RepresentativeAn individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.With this it is clear, the situations in which either a LAR / an impartial witness be considered during an informed consent process

if subject is Illiterate who will come into picture LAR or IW or they can overlap in the case ? (tht's the reason i asked the Question ) Generally LAR comes into picture when subject's enrollment is depended upon LAR's consent ( like minors, unconscious subjects, mentally retarded, etc ) & IW comes into picture juz indicating that whatever has been told to subject is same as that written on Informed consent (or patient information sheet) In case of illiterate subjects ( who just cant read & write but is able to take his own decision ) if LAR fits into IW definition, we don't think there is any problem if LAR acts as a IW (sign, date as a IW) & you can document in source note with reason .

If subject is illiterate you will take who's sign along with thumb impression of Subject ..... LAR or IW or LAR will sign as IW ?

excerpt from Schedule Y

ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering from severe mental illness or disability), the same may be obtained from a legally acceptable representative (a legally acceptable representative is a person who is able to give consent for or authorize an intervention in the patient as provided by the law(s) of India). If the Subject or his/her legally acceptable representative is unable to read/write – an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.So, in the case that you have mentioned, I will consider an impartial witness to be present during the informed consent process.