The term enrolled or enrollement is used many time in ICH E6 (R2) however this word is never defined in the glossary of GCP or other ICH related to Clinical trial.
is that on purpose to be flexible on the definition of enrollement as per protocol design ?
to which time point or clinical trial process do you define this process ?
enrollement : ICF signature by the patient or legal representative
enrollement : ICF signatue + obtaining Randomistion number or patient number (for randomised or open studies)
enrollement : ICH signature + eligibity crietria checked and verfied

We have find also sometimes defintion of Enrolled versus Included subjects in some trials
We have also the case of 2 ICF : one for the Elgibity criteria + one for Clinical trial so to which refers ICF signature regarding enrollement ?

Any thoughts/feedback on how do you use this term in clinical trials ?