// I am hoping that the GP was confused as they just can't "do a trial"//
if they are gonna do it anyway, then they can - because it is not a trial, they were gonna do it ( Trials being radically different, dice and barred cages and fings oh and monkeys)
Collecting anonymised data after doing something you would do anyway is NOT a trial and is good practice
[have you audited XYZ? "oh no, it means collecting data which we cant do and so we have absolutely no idea if it is killing people or not. You see because the law says we cant do it!" is a well trodden path. - and is NOT a bar to audit]
the health care operative should have been counselled:
please do NOT say it is a trial when it is not, nor a secret experiment on ill little kiddies, nor that they have run out of rats, nor that you dunno why they are doing this you really dont, when in fact you know you are collecting safety data......