YouEDC Studio

DM projects

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

A DM project is a study that runs in another system (MainEDC, Rave, InForm, Vault, 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, Portal Owner limits. Only its purpose differs: the data is not entered here, you work with its exports, protocol, reconciliations and reports.

Creating one

YouEDC Studio → “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 administrator.

Team and roles

Project administrator: 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 administrator 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 YouEDC Studio, but take their files from the project data with no second upload, and 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 administrators and data managers run them; a sponsor or viewer sees the pages but cannot upload.

Project data: which tools you can use already

On the project page, above the tool tiles, there is the Project data strip. Press Upload the export and give the study export from your EDC: a ZIP with a file per form, one Excel workbook (for example MainEDC ProjectToOneFile or Modular), CSV or SAS XPT, several files at once are fine. The portal reads which data it holds and lights up the tools that data already allows. The other tiles turn grey but open as usual: you can upload the file they need by hand. A grey tile says what is missing.

The data map keeps only the structure of the export: the tables, the data kinds and the number of rows, patients, sites and visits. The files themselves are kept only with “Keep the files in the project” ticked (see Project data). Uploading and clearing the data map go to the project’s audit trail. Project administrators and data managers upload the export; after a new export from the EDC, upload it again.

When a tile lights up:

Tasks and Lock readiness are always available.
Data review: the export has patient numbers.
What changed: a second export was uploaded, or the previous and the current export of one listing were uploaded together.
Query report and Check effectiveness: there is a query listing.
SAE reconciliation: there are adverse events.
Vendor reconciliation: there are lab results.
Cross-form checks: there are patients and at least one of: AEs, medications, visits with dates, consent dates.
Overdue visits: there are visits with dates.
Lab normal ranges: there are lab results, or the project already keeps normal ranges.
Medical coding: there are AEs, medications or medical history.

On the YouEDC Studio home the tiles light up from all your DM projects together: a tool is lit when at least one project has the data for it. There, MainEDC export lights up for a project whose system is MainEDC, and CDISC and Export to CDISC ODM for any export with patients; the data profiler, the specification check and the protocol analysis are always available. Demo projects get their data map by themselves.

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.

Your organisation’s own items. The Checklists block has “Your organisation’s own items”: an item added there goes into the start-up or database lock checklist together with the standard items, in every DM project of your organisation. Adding and removing items is in the audit trail.