Good day,
I would like to have your opinion on a recent case, where the site PI believes there is no compliance issue in the way he handled the consent process. A non-significant protocol amendment was not timely included in the ICF. The change required 10 times creatinine tests instead of 8 without increased burden for the patient (same number of blood draws and same amount of blood). The PI believed it was beneficial for the patient to have the 2 additional measurement and verbally informed the patient who agreed to it. He documented per hand-writing in ICF and medical files.

We documented a deviation and informed PI, and asked him to inform EC as well.
I read in a training for investigators from a medical society that PIs are allowed to make hand-written notes in ICF (but mandatory to add that to source document). I discourage sites to do that as it might not be legible, clear and understandable, and the color can fade with time. Additionally, site should have a process for verbal consents (to be used on those categories where it is allowed).

Thanks in advance for any thoughts on that!
Kind regards,
C.S.