Hello, does anyone have any direct experience of how much information you can collect on a screening log ? I understand ICH E6(R1) 8.3.20 says we can keep a Subject Screening Log to document identification of subjects who entered pre-trial screening. On the majority of trials I have worked on they ask for patient initials and then basic information regarding eligibility and whether or not the patient went on to become enrolled.

I am receiving instruction from one particular Sponsor that we must remove the patient initials as this constitutes patient identifiable information (PII), in a pool of 300 screened patients with no other information (simply initials alongside eligible yes/no). Does this sound reasonable? Without the initials the screening log wouldn't make much sense or allow us to loosely track and avoid screening a patient more than once.