[ SCENARIO · FREE · DETERMINISTIC ]
Clinical Trial Data Journey
Follow trial data from a participant’s source record through the EDC, queries, and database lock. Your choices decide whether the evidence a regulatory approval rests on is credible and defensible.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
A clinical trial’s data has to be complete, correct, and traceable back to what really happened to each participant. Your choices decide whether it holds up.
Under GCP, data must be attributable and traceable from source to submission, queries resolved, and safety-relevant discrepancies escalated — toward a clean, defensible database lock.
This is the evidence a marketing authorisation is built on. Its credibility is protected — or lost — in exactly these everyday data decisions.
You are a clinical data coordinator. A site has entered data into the EDC that does not match the source record you can see.
Choose what a GCP-compliant data process would actually do — each decision carries forward.
An EDC value does not match the participant’s source document. What do you do?
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across integrity · traceability · timeliness · oversight — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
WHAT THE CORRECT PATH RESTS ON
The primary sources behind the debriefs. The authoritative text lives at each official source.
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →DO IT FOR REAL
- HOW-TO GUIDEHow to Perform Source Data Verification →Check trial data back to source the way the scenario asked.
- TEMPLATESource Data Verification Plan →Decide in advance what is verified, and how much.
- HOW-TO GUIDEHow to Report a Serious Adverse Event in a Trial →Escalate safety findings on their own clock.
KEEP PRACTISING
A free account keeps what you save, remembers where you are across devices, and can send you the weekly regulatory briefing. Create a free account