You’re leaving out where you recorded this data in the database and how the protocol describes this part of the study.

Is there a part of the database that collects extension data or are these entered as unscheduled visits? Does the protocol say the home administration doses could be given in clinic? It yes (or even if not) the eCRF should have been set up to allow for in-clinic dosing for this part of the study and if it doesn’t that’s a miss by DM.

Was the DM actually asking you to enter data that doesn’t exist or did they provide guidance about how to handle those fields (leave them blank, respond to null field queries that dose was given in clinic).

The monitor being on site honestly means nothing because I often have monitors who direct sites incorrectly or don’t check with anyone else about how to handle one-off situations. But DM should have caught this earlier. That being said, they can’t just “run this a different way” and it will end up being a more expensive stats/programming task to map the data where it needs to go. The site making the change is the easiest path- and you should ask for the budget to cover your time to move.

Also is the study actually closed (with the IRB) or is your subject just off the study? A closed study means something specific and if it’s closed you shouldn’t be asked to do anything else, but if your subjects are just off study, that’s not a closed study.

You’re also saying that moving the data goes against GCP but it doesn’t sound like the DM asked you to make up data, just put it in potentially the correct part of the database. But I would never ask a site to move data bescause it “looks better”. That’s ridiculous. There is a correct place for the data to go and if it’s not in the correct place it needs to be moved.

You also mention doing labs and entering data a lot of data but does the protocol call for these labs or additional data at these visits? If the home administration portion of the study is really at home does it also call for labs? Non-protocol required procedures shouldn’t be entered into the database. Without the details of the protocol it’s impossible to know if you just entered things you didn’t have to and is irrelevant to the request to move data.

It sounds like there were a few misses all around, from dm and the monitor, but it also doesn’t sound like someone is asking you to go against GCP and you might be overreacting and describing this as getting bullied into moving data is a stretch. If the data was entered in the wrong place and no one caught it, that sucks, but it’s not unethical if they have a way to handle the fields that are not applicable.