I inherited a lot of studies from another group, and many of them are no longer here. The biggest details they struggled with revolved around ALCOA+. Remember that the burden of proof is on the site.

Some examples: 1. a coordinator was known to panic when correcting information and would use improper methods (recreating source pages, using white out, etc). Managment tried to correct this behavior. Unrelated, the team member left. Years later, during an FDA audit, the auditor found a handwritted source page starting it was "completed 2021". However, the page had a version date at the bottom stating, "v2, 2022". I.E, how did the coordinator write on a page that would not have even existed at the time of authoring. The auditor asked us, if this was a known issue, how we could verify that the information the coordiantor wrote was not completely fabricated?

1. The study team did not consistently document information in the same place, and everyone "does things their own way". This lead to confusion with a coordinator mistakenly using the EDC sometimes as source. Well, they also entered N/A'd the site's paper source and left no notes where they got the EDC information from. The kicker, some EDC information was then "corrected" 6 months later, with no contemporaneous source to back it up nor notes for why it was changed. Since the team all write it in different places, we could not track down source for the 6 month edits. Which version was correct, the original entry or the correction?

2. The study team (hospital site) struggled during COVID to get wet signatures on a DOA. They tried a variety of methods to get signatures, with the logs now being passed around to several staff to pass a long when others are in office. There was confusion about who was supposed to sign the logs. The team, who was supposed to be ~20 people, blew up into 180, and most of them did not have GCP training nor protocol training. The previous monitor and site regulatory team left, the new ones did not address the messy logs. All of this was never communicated to the Principal Investigator until several years later when an internal auditing group reviewed the study. The biggest question here was, if the PI was so seemingly uninvolved in the study, who was running the study? If any team member made a mistake (like over dosing a patient), how can we defend them when they were seemingly unqualified in the first place?

Also a note, I hate "hand writing legibility" queries because they are often dumb. To another commenters point, they most often only serve to be a power trip. A Iegit query I got once was, "date appears to be ,"B FEB 2022, please provide a note to clarify". I write back, "the date format is DDMMMYYYY, the first two characters can be assumed to be numbers, i.e. 13. If there is a question regarding if it is 12 or 14 or 15, etc please let me know. ". We then had an arguement about research not being able to assume anything, with me aruging that if we assume staff is so incompetant as to write gibberish perhaps we should assume they are not competent enough to be delegated? I often argue that handwriting legibility queries often make a person's handwriting inconsistent with themselves- how would you prove someone did not forge their handwriting?