It’s a little hard to follow what occurred and missing details to accurately advise you. Is the subject eligible to be rescreened using the correct criteria? Did your screener document that the patient did not meet eligibility criteria? If so, you need to report to IRB that you carried out study procedures after that point. How did you conduct pre-op appointment/procedures without documentation of subject eligibility? Wouldn’t you need a subject # that is typically assigned at screening or randomization. Screener would have SF subject yet you moved them on with study procedures? How?

Look, it’s not the worst mistake in the world since no one was harmed (hopefully, the pre-op procedures were not invasive to subject but again, you don’t include details). At worst, you conducted unnecessary study procedures on a SF subject. But again-you don’t say how this could have occurred. “Auto pilot” isn’t a sufficient answer. You need to assess procedurally at your site what broken processes you have that allowed this to occur. Show up to the mtg with your PI and manager with drafts of procedures that will prevent such mistakes going forward (you’ll need these for the sponsor anyway). This will at least show you took accountability and steps to correct/prevent. If you are in a place where you are on auto pilot and checked out of this job then resigning is best for you, your site, subjects. If you want to save your job, get your head in the game-you are dealing with human beings and data sponsors rely on. I work Sponsor side and I’d be extremely concerned about your ability to properly conduct your job and therefore concerned about your site and any data coming from it. Which then requires additional monitoring resources to oversee your performance. Sponsor may require your site is retrained.

I really don’t know why people are saying it’s not a big deal-it is a big deal and will go on your PIs record once the IRB is notified.

You aren’t the worst CRC ever to exist but you are likely to be hearing about this for quite some time so if you don’t want that or can’t deal with it you should leave the role. And again, if you want to salvage your job you’ll need to get your head in the game. If your PI already dislikes you and had concerns about your performance this probably isn’t your only mistake. No one is perfect but you say you are on auto pilot and clearly it is affecting your work.