Site activation gates
Track IRB/EC approval, required documents, activation state, and user access against a per-Site checklist.
CTMS
CTMS for activation, delegation, monitoring, and evidence.
Track startup work, DOA currency, training, monitoring findings, and amendment impact without rebuilding the story from trackers.
CTMS operations map
Start-up, delegation, monitoring, amendments.Study startup and Site activation
Activation status should name the blocker and the owner.
Site activation covers feasibility, contracts, budget, IRB/EC approval, required documents, training, access, and first-subject-ready state. CRO operations sees blocker owner and aging; Sponsors see portfolio readiness and country/Site variance.
Essential document dependencies
Keep site activation package status and its document expectations tied to startup work.
Milestone tracking
Record milestone dates against the study plan, with changes captured in the audit trail.
DOA, training, and access
Delegation is checked, not just recorded.
DOA assignment, role access, training currency, and signature evidence move together. When training currency lapses, the delegation is suspended automatically and the delegated task is refused rather than quietly allowed.
Delegation-gated tasks
A delegated task checks the acting person's delegation and training currency at the moment of the act.
Signed delegation log
The DOA log is signed electronically, preserving meaning, signer identity, and date against the Site record.
Suspension trail
Training lapse, suspension, and reinstatement leave audit events rather than an edited delegation history.
Monitoring
Monitoring work should stay tied to its findings.
CRAs plan visits, capture findings, and route follow-up by study, country, and Site. CRO managers see workload and overdue actions; Sponsors see monitoring evidence.
Visit and follow-up planning
Plan monitoring visits, capture findings, assign owners, and preserve closure evidence in the study context.
Findings and follow-up
Findings, action items, owners, due dates, and closure evidence stay in the study context instead of a separate tracker.
Sponsor/CRO oversight
Use permission-scoped views so Sponsor and CRO teams see the same trial state at different responsibility levels.
Amendment impact
Amendment impact should be visible before teams chase the wrong version.
Protocol-version changes show affected countries, Sites, documents, training, consent, EDC forms, RTSM cohorts, and budgets. Per-Site effectiveness stays visible.
Site-level effectiveness
Track IRB/EC approval state and country and Site effective dates by Protocol Version.
Training impact
An effective protocol version raises the training its change requires, rather than leaving it to email coordination.
Connected downstream effects
Activation events refresh eTMF expected-document rules and inform reporting and site payment work.
Integrations and evidence
Connected CTMS keeps record ownership clear.
CTMS reads operational context from eTMF, EDC, identity, and learning, and publishes its own operational status for reporting. Each link keeps source owner, study scope, and audit evidence.
eTMF and CDISC TMF Reference Model alignment
Activation and amendment events refresh EDL expectations, filing needs, document follow-up, and inspection proof.
EDC and protocol context
Subject, visit, and Protocol Version context inform operational work.
Operational reporting
Export study and Site operational status without rebuilding a manual tracker.
First rollout
Bring the study question your team keeps rebuilding.
We will review the product path, system context, owners, evidence, and rollout approach that fit the trial work in front of you.