Speaker 1: That time the subject is not willing to participate, then we have to withdraw the subject from the class. Then, impartial witness. So, we are taking the help of impartial witness, if your subject is illiterate, they are not educated, they do not know to read the content, they do not know to write the details. So, in that case, impartial witness help, we can take it, impartial witness. Can be any person, can be act as an impartial witness, but who cannot influence by the trial team members or who is not a part of the trial team members. Anyone can be impartial witness. Okay, can be anyone, like the relative of the subject also can be this impartial witness, or any other outside of the person also can be this impartial witness. The thing which is that who should be independent of the trial, can be any family member, but it should not be any member of the side staff.

Speaker 2: It should not be... The relatives cannot become LARs, right?

Speaker 3: Relatives means that close relative, like the husband and wife, legally valid.

Speaker 2: Okay. So, they can become LAR and witness, both, they are eligible for both. Yes, right.

Speaker 1: Okay. Thank you. Okay. So, which is required in case if the subject is illiterate. Okay. If the subject is illiterate, then we are taking impartial witness course. Okay. Because if you inform some information about the trial, the subject can understand all the information. But the thing is that they cannot write and they cannot read the content, that is it. But they can understand whatever the information which we are providing, and they also have the ability to take the decision to be participate in the trial. But as per the rule, subject should be read the content, subject have to fill the details in the content. So, for that, they are not able to do it. But other things they can understand, right? If someone is not able to read and write, but if you provide some information, they will be able to understand the information, right? So, in that situation only, we are taking the impartial witness, in case if anything will happen. But nowadays, it's not always like the impartial witness, it's not usually we can see. Most of them have some qualifications, at least they go to the schools. Okay. So, previously, this equation happened. Now also, for just like a 1% situation, we are facing for impartial case, like who have any old age people, like who is like more than 70 years old, for that case only, which I saw for this case is applicable. Okay. So, who is independent, this person impartial witness, who should be dependent of the trial, who cannot be any trial team members or the hospital staff. Okay, because that institution is always a part of the trial, right? So, it cannot be any trial team members or any other representative of that institution. So, who cannot unfairly influenced by the people involved with the trial, cannot be influenced by the investigator or any other coordinators, they should not influenced by any other people also. Then who should be attend at the time of informed consent procedure, then not only for the subject, in case, for example, your subject have Alzheimer's, okay, so, in that case, we require the help of LAR, but that LAR is also illiterate, then what to do, then that time also we can take the help of impartial witness, the subject LAR, they also illiterate, so, we can take the help of impartial witness, okay. Yes, ma'am. So, who attend the informed consent procedure, if the subject or the subject legally acceptable profession may be taken off free, so, what to do, on behalf of the subject, this person will raise the consent document and whatever the information investigators provided during that time also this person and the subject will be present and both these persons and impartial witness and the subject will discuss about the trial, then who will raise the consent also on behalf of the subject and in the consent some information where subject may feel it, but subject is illiterate, so, they cannot feel that it is, so, that also this impartial witness, they will, right. So, I have a doubt. So, here in this case, subject, there is a section for the subject signature. So, in that case, what we will do, there is a section for the subject signature, so, here what we will do? Thumb impression can be. Thumb impression, yeah, we can provide the thumb impression of the subject, okay, we can provide the thumb impression of the subject also, okay, so, that we are doing, but there is a certain situation which we face that even the subject is literate, someone, they know to do the signature, like for the signature, there is no language, if you provide just a plus mark, then also it is a signature for someone, okay. So, for someone, they will be illiterate, but they can do the signature. So, in that case, they can put their signature, but in the source document, we should be document that subject just know to do the signature, so, subject and the signatures in that case, but the date that we can keep as blank, okay, the portions have the name of the subject, signature of the subject or the thumb impression, then take. So, the name and the date which we can be keep as blank, then that signature or the thumb impression we can provide, okay. So, this is the requirement of this impartial business and a layer. Then, next is about, this is the one which is present in your informed consent form, okay, what is present in informed consent form? So, here in the informed consent form, it contains some information which our subject or their LAR or their impartial business, which need to fill it. So, it contains name of the subject, the full name of the subject, okay, first name, middle name, last name, full name, that should be, okay, then initials of the subject, how we can write the initials of the subject, like we provide the first name, middle name, last name, then what is the initials of the subject? Any idea?

Speaker 2: Some people will not have middle and last name. So, they will have initials, only the first name and the initials.

Speaker 1: It is not that initial.

Speaker 2: And signature, it should be. Mr. Mrs. No.

Speaker 1: Enrollment number. Here initial, it is like a short name of the subject, okay, first letters, right. So, my full name, which is OJ Jacob. So, my initial, which is S dash J, because I do not have any middle name, I have this first name and last name only. So, my initial S dash J, okay, so like that we have to provide the initials, first letter of the first name, first letter of the middle name, first letter of the last name. There is no middle name. We can provide just that type of. Clear? Clear? Yes, ma'am.

Speaker 2: Yes, ma'am.

Speaker 1: So, that is like that initials we have to provide. Not only here, in your delegation law also, for you, if you are a coordinator, for you also, you have to put their initials. Again, a short signature or initials you have to provide. Then, date of birth, complete date of birth, it should be contained year, month, then date, everything. But in certain subjects, they may know, do not know what is their correct date of birth. But in their other code, ordinary identity proof, some year will be there, but the date and month, it will be at this. So, do you have any idea what we will do in that case? We will consider that year, not a year, that date and month as first gen.

Speaker 2: Ma'am, because we will take the year and then we write one gen or 30.

Speaker 1: One gen, one gen than a year.