Amendment release
Check ethics approval, site training, and protocol version before an amendment reaches a site.
Clinical trial operations
Release protocol amendments to ready sites without chasing every sign-off
The trial operations agent releases an amendment when a site is ready. It stops when ethics approval is pending, and a site with open training goes to clinical operations to decide.
Connecting the agent? See the developer guide for Clinical Trials
One amendment across many sites
The study team wants the new version live wherever it is allowed to be.
Study manager
Wants the amendment released at every ready site without tracking each one by hand.
Clinical operations lead
Reviews the sites the agent held for training and decides which can go ahead.
Quality assurance
Approves changes to the release rules before they reach the production agent.
Auditor
Reviews the release history inside an engagement scoped to the study application and its dates.
Trial work where an agent can help
The agent handles the checks. Clinical judgment and regulated approvals stay with your trial professionals.
Eligibility pre-screening
The agent flags likely candidates with the criteria it used. Enrollment stays a clinical decision.
Protocol-deviation review
Keep a proposed correction linked to its protocol version, so a reviewer can see the basis for the change.
Where amendment rollouts slow down
Each site moves at its own pace, and the release decision depends on approvals held in different systems.
Which sites have ethics approval for this version, and who confirmed it?
A site with incomplete training needs a decision, not another reminder email.
During an inspection, the release history has to show which protocol version applied at each site.
Built-in handoff
Quality assurance approves release rule changes
Quality assurance approver
A change can run in Shadow first, showing which site releases it would stop. An engineer’s change to the production agent waits for quality assurance to approve it.
See the six role portals and how work moves between themYour trial systems stay the source
Links, not copies
Point to records in your data capture, trial management, and safety systems instead of copying them.
Pseudonymous references
Participant identities and unblinded details stay in the systems that control access to them.
Sponsor oversight
Records support the sponsor oversight described in ICH E6(R3). Regulated decisions stay with your team.
Try it on your next amendment
Start with one study and the release rules your sponsor team already follows.