Premature amendment distribution
Amendment v3 is sent to site S04 before the sponsor and Central IRB approvals are effective.
HELDDownstream blocked
Open the recordSynthetic demonstration. No real patient data and no clinical operations. This replay does not connect to an EDC, CTMS, IRB, sponsor, or patient system.
ICH E6(R3), 21 CFR Part 11, and 21 CFR 312.32 are informative references for this illustrative policy. They are not certifications and not a claim of regulatory approval, validated GxP use, or a real trial integration. Part 11 suitability needs controls beyond a demonstration signature and hash chain. No clinical recommendation is made.
Radien · Clinical trial authority replay
Fictional protocol PLT-001
Each row is proposed, then evaluated against the policy, credentials, protocol version, approvals, consent, and data-use rights that were effective at the action time. The simulated downstream step is recorded only after AUTHORIZED.
Sealed run f1f53746-01ff-475f-ad22-19a5d526d83c · 226 attempts · 183 simulated executions · 43 blocked
AUTHORIZED
183
HELD
30
ESCALATED
8
DENIED
5
By agent
| Agent | Authorized | Held | Escalated | Denied |
|---|---|---|---|---|
| agent.amendment | 4 | 5 | 0 | 0 |
| agent.reconciliation | 116 | 3 | 3 | 1 |
| agent.adaptation | 2 | 4 | 0 | 0 |
| agent.safety | 3 | 1 | 4 | 0 |
| agent.export | 3 | 4 | 0 | 2 |
| agent.site_activation | 5 | 2 | 0 | 0 |
| agent.arm_onboarding | 47 | 11 | 1 | 0 |
| human.dsmb | 1 | 0 | 0 | 0 |
| human.pi.S01 | 0 | 0 | 0 | 1 |
| human.operator | 0 | 0 | 0 | 1 |
| human.sac | 2 | 0 | 0 | 0 |
Rule coverage
| Rule | Pass | Fail | Indeterminate |
|---|---|---|---|
| CT-01 | 221 | 4 | 1 |
| CT-02 | 207 | 3 | 0 |
| CT-03 | 68 | 6 | 0 |
| CT-04 | 52 | 7 | 0 |
| CT-05 | 2 | 3 | 0 |
| CT-06 | 2 | 4 | 0 |
| CT-07 | 117 | 5 | 1 |
| CT-08 | 3 | 4 | 1 |
| CT-09 | 49 | 4 | 0 |
| CT-10 | 4 | 5 | 0 |
| CT-11 | 223 | 3 | 0 |
Disguised unblinding request
A quality-check label asks for treatment assignment. The field list is what the rule reads.
DENIEDDownstream blocked
Open the recordMismatched arm stop
An adaptation cites the sealed Arm B stop but applies it to Arm A.
HELDDownstream blocked
Open the recordLate, misrouted serious event
A serious event is sent to the data manager after the fictional 24-hour routing window.
ESCALATEDDownstream blocked
Open the recordCross-arm export
Arm A's data-use agreement is asked to release Arm B fields.
DENIEDDownstream blocked
Open the recordEscalation queue
An escalation is not access and not an authorization. A later resolution is a new record.
- SCN-LATE-SAEwaits for Dr. Owen Blake (medical_monitor)
Original verdict stays ESCALATED. Downstream status: blocked.
No later resolution is sealed for this item.
- BND-CT04-PENDINGwaits for Riley Chen (sponsor)
Original verdict stays ESCALATED. Downstream status: blocked.
No later resolution is sealed for this item.
- BND-CT07-ENDPOINTwaits for Dr. Priya Shah (sac)
Original verdict stays ESCALATED. Downstream status: blocked.
Later record SCN-ESCALATION-RESOLUTION is AUTHORIZED. It does not rewrite the original.
- BND-CT07-ELIGIBILITYwaits for Dr. Priya Shah (sac)
Original verdict stays ESCALATED. Downstream status: blocked.
No later resolution is sealed for this item.
- BND-CT07-SAFETY-FIELDwaits for Dr. Priya Shah (sac)
Original verdict stays ESCALATED. Downstream status: blocked.
No later resolution is sealed for this item.
- BND-CT08-LATE-1MSwaits for Dr. Owen Blake (medical_monitor)
Original verdict stays ESCALATED. Downstream status: blocked.
No later resolution is sealed for this item.
- BND-CT08-MISROUTEwaits for Dr. Owen Blake (medical_monitor)
Original verdict stays ESCALATED. Downstream status: blocked.
No later resolution is sealed for this item.
- BND-CT08-NONSERIOUS-LATEwaits for Dr. Owen Blake (medical_monitor)
Original verdict stays ESCALATED. Downstream status: blocked.
No later resolution is sealed for this item.
Decisions
| Attempt | Operation | Verdict | Downstream |
|---|---|---|---|
| SCN-PREMATURE-AMENDMENT S04 | distribute_amendment | HELD | Blocked |
| SCN-DISGUISED-UNBLIND S01 A | quality_check | DENIED | Blocked |
| SCN-MISMATCHED-ARM-STOP S01 A | implement_adaptation | HELD | Blocked |
| SCN-LATE-SAE S02 A | report_safety | ESCALATED | Blocked |
| SCN-CROSS-ARM-EXPORT S01 B | export_data | DENIED | Blocked |
| SCN-SITE-ACTIVATE-S01 S01 | site_activation | AUTHORIZED | Simulated only |
| SCN-SITE-ACTIVATE-S02 S02 | site_activation | AUTHORIZED | Simulated only |
| SCN-SITE-ACTIVATE-S03 S03 | site_activation | AUTHORIZED | Simulated only |
| SCN-SITE-ACTIVATE-S04 S04 | site_activation | AUTHORIZED | Simulated only |
| SCN-SITE-ACTIVATE-S05 S05 | site_activation | AUTHORIZED | Simulated only |
| BND-CT11-MISSING-TRAINING S06 | site_activation | HELD | Blocked |
| BND-CT11-BEFORE-CONTRACT S01 | site_activation | HELD | Blocked |
| SCN-DIST-V2-PASS S01 | distribute_amendment | AUTHORIZED | Simulated only |
| BND-CT03-BEFORE-SPONSOR S03 | distribute_amendment | HELD | Blocked |
| SCN-DIST-V3-PASS S01 | distribute_amendment | AUTHORIZED | Simulated only |
| BND-CT03-IRB-NOT-YET S02 | distribute_amendment | HELD | Blocked |
| SCN-DIST-V4-PASS S01 | distribute_amendment | AUTHORIZED | Simulated only |
| BND-CT03-V4-PREMATURE S05 | distribute_amendment | HELD | Blocked |
| SCN-DIST-V1-PASS S02 | distribute_amendment | AUTHORIZED | Simulated only |
| BND-CT03-V1-BEFORE-IRB S06 | distribute_amendment | HELD | Blocked |
| SCN-ARM-C-ACTIVATE S01 C | activate_arm | AUTHORIZED | Simulated only |
| SCN-ARM-C-ACTIVATE-S02 S02 C | activate_arm | AUTHORIZED | Simulated only |
| BND-CT04-PENDING S03 C | activate_arm | ESCALATED | Blocked |
| BND-CT04-SELF S01 A | activate_arm | HELD | Blocked |
| BND-CT04-BEFORE-SIGNOFF S05 C | activate_arm | HELD | Blocked |
| SCN-ARM-B-ACTIVATE S04 B | activate_arm | AUTHORIZED | Simulated only |
| SCN-ENROLL-S01-A-1 S01 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S01-A-2 S01 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S01-B-3 S01 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S01-B-4 S01 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S01-CONTROL-5 S01 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S01-CONTROL-6 S01 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S02-A-7 S02 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S02-A-8 S02 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S02-B-9 S02 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S02-B-10 S02 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S02-CONTROL-11 S02 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S02-CONTROL-12 S02 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S03-A-13 S03 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S03-A-14 S03 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S03-B-15 S03 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S03-B-16 S03 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S03-CONTROL-17 S03 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S03-CONTROL-18 S03 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S04-A-19 S04 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S04-A-20 S04 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S04-B-21 S04 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S04-B-22 S04 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S04-CONTROL-23 S04 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S04-CONTROL-24 S04 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S05-A-25 S05 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S05-A-26 S05 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S05-B-27 S05 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S05-B-28 S05 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S05-CONTROL-29 S05 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S05-CONTROL-30 S05 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S06-A-31 S06 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S06-A-32 S06 A | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S06-B-33 S06 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S06-B-34 S06 B | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S06-CONTROL-35 S06 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| SCN-ENROLL-S06-CONTROL-36 S06 CONTROL | enroll_subject | AUTHORIZED | Simulated only |
| BND-CT09-RECONSENT-HELD S01 A | enroll_subject | HELD | Blocked |
| BND-CT09-RECONSENT-PASS S01 A | enroll_subject | AUTHORIZED | Simulated only |
| BND-CT09-NO-AUTO-RECONSENT S01 B | enroll_subject | AUTHORIZED | Simulated only |
| BND-CT02-ARM-C-TOO-EARLY S01 C | enroll_subject | HELD | Blocked |
| BND-CT02-GLOBAL-V4-NOT-AT-SITE S04 A | enroll_subject | HELD | Blocked |
| BND-CT04-ARM-B-STOPPED S01 B | enroll_subject | HELD | Blocked |
| BND-CT01-NARROW-SCOPE S02 A | enroll_subject | HELD | Blocked |
| BND-CT01-EXPIRED-EXACT S01 A | enroll_subject | HELD | Blocked |
| BND-CT01-EXPIRED-BEFORE S01 A | enroll_subject | HELD | Blocked |
| BND-CT01-CREDENTIAL-MISSING S03 CONTROL | enroll_subject | HELD | Blocked |
| BND-CT01-RECORDED-BEFORE-ACTION S01 A | enroll_subject | HELD | Blocked |
| BND-CT05-DSMB-PASS S01 A | request_unblinded_data | AUTHORIZED | Simulated only |
| BND-CT05-PI-DENY S01 A | request_unblinded_data | DENIED | Blocked |
| BND-CT05-ESCALATION-DOES-NOT-GRANT S01 A | resolve_escalation | DENIED | Blocked |
| BND-CT05-SAC-PASS S03 B | request_unblinded_data | AUTHORIZED | Simulated only |
| BND-CT06-EXACT S01 B | implement_adaptation | AUTHORIZED | Simulated only |
| BND-CT06-WRONG-PARAMETER S01 B | implement_adaptation | HELD | Blocked |
| BND-CT06-NOT-YET S03 B | implement_adaptation | HELD | Blocked |
Showing 80 of 226. Narrow the filters to see the rest.