Site activation gates
Track IRB/EC approval, required documents, contract and budget state, user access, milestone readiness, and blocker ownership.
CTMS
CTMS for activation, delegation, monitoring, and evidence.
Track startup blockers, DOA currency, training, RBM signals, monitoring findings, amendment impact, and Sponsor/CRO acceptance without rebuilding the story from trackers.
CTMS operations map
Startup, 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 package status, eTMF filing needs, training prerequisites, and approval evidence tied to startup work.
Milestone history
Show effective dates, source evidence, aging, owner, and reason-for-change rather than only a status label.
DOA, training, and access
Delegation controls access, not a side tracker.
DOA assignment, role access, training currency, procedure eligibility, and signature evidence move together. Training expiry suspends delegated activity. Retroactive gaps become protocol deviations, not edited history.
DOA-derived access
Study permissions follow delegated responsibility, role assignment, Site scope, and procedure eligibility.
Signature evidence modes
Native e-signature, delegated e-signature, and external upload routes preserve meaning, signer, date, and source evidence.
Inspector query
Find activity performed outside valid delegation or training currency without reconstructing the DOA log manually.
Monitoring and RBM
Monitoring work should stay tied to risk signals and findings.
CRAs plan visits, capture findings, route follow-up, and review RBM signals by study, country, and Site. CRO managers see workload and overdue actions; Sponsors see risk posture and monitoring evidence.
Visit and follow-up planning
Plan monitoring visits, capture findings, assign owners, and preserve closure evidence in the study context.
RBM signal review
Review enrollment, query, deviation, safety, visit, and site-performance signals without separating them from action ownership.
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, monitoring plans, budgets, and activation gates. Per-Site effectiveness stays visible.
Site-level effectiveness
Track IRB/EC approval state, country and Site effective dates, and procedure eligibility by Protocol Version.
Training and re-consent impact
Show training assignments, consent-version impact, safety-relevant changes, and Site follow-up without email coordination.
Connected downstream effects
Activation events refresh eTMF EDL expectations and inform EDC, RTSM, monitoring, and reporting work.
Integrations and evidence
Connected CTMS keeps record ownership clear.
CTMS reads operational context from eTMF, EDC, RTSM, identity, learning, Site source, labs, safety, and reporting systems. Each connection keeps source owner, data class, study/Site scope, run history, review status, 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, RTSM, and protocol context
Subject, visit, query, randomization, cohort, and Protocol Version context inform operational work.
BI and inspection evidence
Export operational status, record ownership, and evidence 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.