In our system our participants must sign a consent form before they are entered into OpenSpecimen. The consented participants are added to a Collection Protocol called “CONSENTED”. For those participants that do not consent, they are stored in another system (Patient Registry System) until they consent. If they never consent, then they never get entered into OpenSpecimen.
We wish to have all participants entered into OpenSpecimen.
One possibility of handling unconsented participants is to enter them into OpenSpecimen under a Collection Protocol called “UNCONSENTED” and when they do consent, they are moved to the “CONSENTED” protocol.
Does this sound reasonable? How are other people handling situations similar to this?
Any suggestions would be appreciated.
Thanks in advance.
Note: This scenario was simplified for easy understanding.