Sites and team
Sites, investigators, roles, site access, invitations.
Roles
- Project administrator: settings, team, launch and database lock. Whoever creates the project becomes its administrator; a project may have several.
- Data manager: data and queries, audit trail, exports.
- Investigator: data entry at their sites.
- Monitor: data review and queries.
- Viewer: read only.
- Statistician: downloads data cuts de-identified, sees no patients and no sites (Data cuts).
Site access
By default a person sees all sites. Tick specific sites and they see only those. Useful for investigators and monitors.
The Sites page
Sites in the study menu lists every site with its status, principal investigator, enrolment target and team. A site is being activated (no enrolment yet), enrolling, or has enrolment closed; patients are enrolled only while it is enrolling. Open a site to change it or to invite people straight to it: an investigator invited there sees only that site. A new site is first looked for in your organisation's site directory, so the same hospital is not entered twice.
The sites and people of all your studies at once: the “Sites”, “People in my studies” and “Invitations pending” numbers on the home page open one list with filters: sites without a principal investigator, people who have never signed in, invitations not accepted yet (the oldest first), people of one role. The lists cover the studies where your role sees the team.
Many sites from Excel
On Sites, Many sites from Excel adds a whole list: one row per site with the number in the study, name, department, city, ИНН, principal investigator, the PI's e-mail, target and status (download the Excel template there). Each row is found in your organisation's site directory or gets a new card; a row that only may be a card already there is not added but shown to you, to add by hand. A site already in the study or a number already taken is skipped with the reason.
The principal investigator invites the site team
When a row has the PI's e-mail, the PI gets an invitation as the principal investigator of the site (the badge “site PI”). In the study they see My site: their site with its team, and they invite investigators and coordinators of their site themselves and revoke those invitations. People they invite are investigators of that site only; the PI cannot invite to other sites, give another role or change the study team. The manager makes any investigator a site PI with “site PI” in the team, or takes it away; every change is in the audit trail.
Invitations
Enter an e-mail and a role. The portal sends a letter with a link; you can also copy the link and send it yourself. Someone without an account signs up through that link. An unused invitation can be revoked. Invitations older than 7 days show up on the desk.
Inspectors and auditors
For an inspection by an authority or an audit by the sponsor, invite the person with the role Inspector / auditor and the last day of access (required, at most 120 days ahead). Tick the sites under review, or none for all sites; tick “unblinded” only if they must see the arms. The inspector sees every page of the study a project administrator sees (patients, forms, queries, the audit trail, the eCRF and its versions, documents, YouEDC Safety), changes nothing and takes no file out: the copies they ask for are made by the team. A banner reminds them of this and of the last day.
The team page shows the study's inspectors and auditors, how many pages each opened and what they opened last, so the team knows what is being looked at. Each visit is in the audit trail. After the last day the study no longer opens for them and the portal closes the access by itself, with a record in the audit trail; to give access again, invite them again with a new last day. Any member can also get a last day of access (“until” when you edit them), for example a monitor from a CRO whose contract ends.
Access review
Every 3 months (or 1, 6, 12, or never: Review every on the review page) a study manager goes through everybody who can open the study: role, sites, unblinding, last sign-in, second factor and last day of access; no sign-in for more than 90 days and no second factor are marked in red. Keep each access the person still needs, close the rest (invitations are revoked the same way), add a comment and sign with your e-mail and password. The closed accesses close at once and are in the audit trail; the signed review keeps the list as it was with your decisions and its SHA-256, ready to print for the inspection. When a review is due, the team page and the desk say so. A manager never closes their own access in a review.
The Portal Owner also sets in Administration › Settings after how many days without a sign-in (60, 90, 180 or 365) the portal closes an account nobody uses. The person gets a warning letter a week before; a closed account keeps its data and its place in the studies, and the Portal Owner opens it again on its page. Portal Owners and the demo accounts are never closed.
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