A site is opened in two separate acts by two separate people, and neither can do the other's. Registering a site gives it no ability to do anything; adding a coordinator gives them no access. Both are deliberate.
The flow
The handoffs
| # | Who | Does | Result |
|---|---|---|---|
| 1 | Project Manager | Registers the site and names the principal investigator (Open a site) | The site exists and can do nothing; the investigator has a site account with the investigator role |
| 2 | Project Manager | Records the IRB or IEC approval and the training confirmation, and activates | The site can screen and enroll |
| 3 | Project Manager | Provisions the coordinator, the pharmacist and other staff (Staff a site) | They appear on the site team as Pending delegation, with no access |
| 4 | Principal Investigator | Signs each person's delegation of authority with a fresh code, their typed name and the confirmation that the person is trained and qualified | Their access begins on the entry's start date |
The two gates
Activation needs evidence, not a decision. A site moves from registered to active only when an approval reference and date are recorded and the protocol training is confirmed. There is no override. Reinstating a suspended site does not run the gate again: it was already cleared.
Whoever provisions cannot authorize. The study team adds the people; only the site's principal investigator can make them able to work, by signing a delegation of authority. Until that signature exists the person can sign in and see nothing of the study. Nobody signs their own entry, the Project Manager included. The investigator named when the site is registered signs for themselves, so there is no delegation to wait for.
This is the separation of duties an inspector looks for: the person granting access and the person accountable for the site's conduct are not the same person.
The delegation log
Each person has a log of entries with the tasks delegated, dates and status. Access to participant data begins only when an entry has been signed and covers today. An amendment to a delegation (other tasks, other dates) is a new entry that takes effect when the investigator signs it and ends the one in force; an entry can be ended with a reason.
Who may and may not be site staff
Site staff and sponsor staff are never members of the organization, and organization members are never site staff; a person has one role on a study and cannot be on two sites of the same study. The Add dialog refuses before anything is sent, and the server and the database refuse too (Who can and cannot).
What suspension and closure mean
Suspension is reversible and holds the site's work; closure is final. Neither deletes anything: a closed site keeps its participants, its data and its history. Both need a written reason. Nothing about a person's assignment is deleted either: someone leaving a site is retired, and the record of what they did stays attached to the trial.
Test sites and production sites are different sites
A site registered while the study was in UAT belongs to the test workspace. Production sites are registered fresh in Live, before the first go-live: the go-live checklist needs at least one active Live site with an investigator at every active one. Do not plan to promote your UAT sites.
Where this goes wrong
| Symptom | Cause |
|---|---|
| "The site can't enroll anyone" | It is registered, not active. Record the approval and confirm the training |
| "The coordinator sees an empty study" | The investigator has not signed their delegation yet, or its dates do not cover today |
| "Our UAT sites are not in Live" | Expected. Register the production sites before go-live |
| "I can't provision this person" | They are an organization member, or already hold a role on the study, or are on another site of it |