Can AI do patient enrolment and a protocol visit?
An expert breakdown of a typical process from public sources, worked out by the same rules as your own check.
0 of 8 steps go to an agent
Goes to an agent (0)
An agent does these steps on its own.
No steps here.
AI drafts, a person checks (7)
AI prepares the work; a person reviews and confirms it.
Check eligibility against the inclusion criteria from the medical data
A person signs off: the law or a regulator holds someone accountable for it.
Informed consent: explanation, questions, signature before any procedures
A person signs off: the law or a regulator holds someone accountable for it.
Enrolment and randomisation by the protocol procedure
A person signs off: the law or a regulator holds someone accountable for it.
Record the source data at the time of performance
A person signs off: the law or a regulator holds someone accountable for it.
Transfer to the electronic form and raise the data queries
A person signs off: the law or a regulator holds someone accountable for it.
Document the protocol deviation and notify the sponsor
A person signs off: the law or a regulator holds someone accountable for it.
Monitoring visit: check the form against the source records
A person signs off: the law or a regulator holds someone accountable for it.
Stays with people (1)
These steps need a person's judgement or presence.
Record the adverse event and assess causality
Stays with people: it takes judgement that depends on your business context.
- Judging risk or priority in a business context
1 step outside what AI can work on
Physical work, or nothing AI could apply itself to. These steps count in no figure.
Conduct the visit per protocol: procedures, sampling, scales
Stays with people: someone has to be there in person.
- Instrumental reading of a value from an object
- On-site sensory assessment of the condition of an object or a person
Sources
- ema.europa.eu · Regulator
- irb.wisc.edu · Research
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