Hi everyone,

I have been posed a question that I am struggling to answer effectively, so hoping someone can help!

For a CTIMP that we will be coordinating, I have been told that (hypothetically) there could be a patient who did not enter the trial solely because they did not want to travel from their home to the site just to sign the ICF. The trial involves a rare disease so long distances can be involved.

In this scenario, they would be provided with the PIS and have a discussion with the PI via phone to discuss the trial in detail and have their questions answered.

Although I am aware that it is not good practice to do so (risk of falsification, etc), is there any regulatory/GCP reasoning to stop the patient signing the ICF at home and posting it back to the site, where the PI would then counter-sign?

If the full process was covered in detail in the medical notes to explain the discrepancies in dates, and how the patient was provided with the PIS etc, does this sound acceptable?

All thoughts are very welcome - many thanks in advance!