What is due today
Document requests reach the site in one list, each carrying the study, the document asked for, who wants it, and when it is due.
Sites
Site work queues tied to delegation, training, and protocol version.
PIs, coordinators, research nurses, and site managers need one clear queue for what is due, which study it belongs to, which protocol version applies, and whether the person assigned is allowed to act.
Coordinator queue
Sites need fewer duplicate requests and clearer authority.
Show each coordinator what is due before the next visit: study, protocol version, consent state, source question, owner, and whether DOA and training allow action.
Allowed to act
Delegation, training currency, Site role, and protocol version are visible before work begins.
Coordinator question
Which study is this for? Which protocol version applies? Is this person delegated and trained to do the work?
PI accountability
PI oversight needs live delegation and source evidence.
PI accountability is not satisfied by a DOA log discovered at close-out. Delegation, source evidence, signature meaning, training currency, and monitor follow-up need to be visible during the trial.
DOA and signatures
Delegation changes, signature evidence mode, meaning, signer identity, and effective dates stay connected to the Site record.
Source and consent
Source evidence, consent-version context, eISF exchange, and monitor follow-up stay tied to the right subject, Site, and trial.
PI oversight question
Who was delegated when the work happened? Which consent version was active? What evidence supports the Site response?
Sponsor and CRO work
Site collaboration should reduce portal fatigue.
Sponsors and CROs need evidence, but Sites need the work to arrive in a way that respects staffing, source systems, IRB cadence, and patient-care interruptions.
Fewer repeated asks
Site requests carry study, Site, artifact, owner, due date, protocol version, and source context instead of arriving as disconnected messages.
Site portfolio context
High-performing Sites can see cross-study obligations without losing Sponsor-specific permissions or trial boundaries.
Site burden question
Which requests are duplicates? Which work is patient-facing? Which evidence flows to the Sponsor, CRO, or eTMF?
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.