Filing of PIS in ISF with original consent

Good afternoon,

We have had heated discussions within our department about the statement in [COLOR=#ff0000]red [/COLOR]below.
The argument for not filing the subject information sheet in the ISF is that the one given to the patient “originally” may not be with them at the time of signing the consent form, they may have left it at home for instance. The other argument is if the subject information sheet was sent to the patient as an attachment in an email, if the patient does not print this out and bring it to the consent meeting, how can this be filed?

I think its fairly clear but colleagues do not! Thoughts?

Pg 375 2012 GCP Guide:

“In order to demonstrate that subjects were provided with the most up to date information (including safety information) for the trial, it should be clear which version of the subject information sheet subjects had given consent to. Issues can arise if for example, the informed consent form did not make reference to the version of the subject information sheet and the site did not retain a copy of the subject information sheet given to the subject. [COLOR=#ff0000]It is therefore recommended that a copy of the subject t information sheet and informed consent for are kept together in the medical notes, with the originals in the investigator site file[/COLOR]. A copy of both these document should be given to the subject.”