Section 06
Screening workflows
Screening states, permitted transitions, rationale and investigator referral.
States
- Awaiting Review
- More Information Required
- Potentially Eligible
- Referred for Investigator Review
- Not Eligible
Transitions
Coordinators move records from Awaiting Review to More Information Required, Potentially Eligible or Not Eligible, and refer Potentially Eligible candidates to an investigator. Investigators return, request information or record Not Eligible. Reopening a Not Eligible record requires a recruitment manager and a reason.
What screening states are not
They record operational decisions by people. They are not automated clinical determinations, and enrollment eligibility is confirmed by the investigator under the protocol in the study’s own systems.