DM workspace

DM projects

A study in another system: team, tasks, checklists, status, archive.

A DM project is a study that runs in another system (Rave, InForm, Vault, OpenClinica, REDCap, Excel) and that you manage as a data manager. It is the same kind of project as a youEDC study: a team with roles, an audit trail, admin limits. Only its purpose differs: the data is not entered here, you work with its exports, protocol, reconciliations and reports.

Creating one

DM workspace → “New DM project”, or “New project” and the card “Work with data from another system”. Give a name, a code (usually the protocol number, for example ONC-301), the system, the phase and the dates. The creator becomes the project manager.

Team and roles

Project manager: settings, team, all tools.
Data manager: works with the data and the tools, keeps the task list; cannot change the team.
Sponsor / viewer: sees the overview and the results, changes nothing.

Invitations work as in a study: by e-mail or by a link. A DM project has no sites, so there is no site access to set.

Tasks

A shared task list with categories (start-up, conduct, lock) and due dates, plus two checklists in one click: start-up (DMP, eCRF and edit check specifications, UAT, go-live) and database lock (12 standard items; the due date is the planned lock date). Every change to the list goes to the project’s audit trail with the person and the time.

Status

Start-up, conduct, close-out, database locked: set it by hand as the study moves in the other system. Unlike an EDC study, the lock does not freeze a DM project: final listings and archiving go on after it.

Archive instead of delete

A project is never deleted, because its audit trail must stay. Archive it in Settings: it becomes read-only and leaves the lists (the “Archived” filter shows it). A project manager can restore it.

Tools

The project menu holds the task list and the tools on exports: what changed, query report, SAE and vendor reconciliation, data review, cross-form checks, overdue visits, check effectiveness. Inside a project they work exactly as in the DM workspace and still keep none of the uploaded data, but every run goes to the project’s audit trail with the person and the time, and the Excel report name starts with the project code (for example ONC-301_what-changed_….xlsx). Project managers and data managers run them; a sponsor or viewer sees the pages but cannot upload.

Earlier “external studies” became DM projects automatically, with their tasks, notes and dates. Their codes were kept where possible; if a code was already taken on the portal, a number was added, for example ONC-301-2.