Project data: deliveries and history

Upload an export once, every tool takes it; YouEDC Studio inside a Capture study.

A data manager runs the same export through many tools: data review, reconciliations, the query report, overdue visits. Before, the file had to be uploaded into each tool again. Now the export is uploaded to the project once, kept there with its history, and every tool takes it from a list. In YouEDC Capture studies there is nothing to upload at all: the Studio tools work on the study's live data.

Deliveries and history

Open the DM project and click the “Project data” strip above the tool tiles. Upload the study export: a ZIP with a file per form, an Excel workbook, CSV or SAS XPT, several files at once are fine. With “Keep the files in the project” ticked the upload becomes a numbered delivery (#1, #2…). You can add a note, for example “weekly export, cut-off 30 Sep”.

The table “Deliveries and their history” shows every delivery: when and who uploaded it, where from (the data page, a tool, a snapshot of the study), its files with their size and SHA-256. The SHA-256 always proves which exact file a report was made from. The portal still reads which data the exports hold and lights up the tools that data allows.

The tools take files from the project

Under every upload field of a project tool there is a list “Take from the project data”. Pick a file of the delivery you need and run the tool: nothing to upload again. For “What changed” pick the previous file from an older delivery and the current one from the newer. A file uploaded right in a tool, with “Keep the uploaded files in the project data” ticked, becomes a delivery too. A file the project already has is not kept twice.

YouEDC Studio in Capture studies

A Capture study's menu has a YouEDC Studio item. It shows the study's live data as files: the forms, the patients, queries, visits with dates, page status and the audit trail of data changes. In a tool, pick such a file in the group “Live data of this study”, with no export. One sees what the study export would give: only one's own sites, the forms for the unblinded team hidden, patients who withdrew the use of their data left out.

The button “Keep a snapshot of the data” keeps the current data as a delivery. A week later “What changed” compares the snapshot with the live data and shows what changed. Files from other systems (a safety database, a central laboratory) are uploaded on the same page and kept with the study. The study manager and data managers see the YouEDC Studio item: they have the rights to the DM tools and to export the data.

Rights, audit and removal

Only the project manager and data managers open, download and use the files. A sponsor or a viewer sees the history, not the files.
The project's audit trail records keeping a delivery, downloading a file, every tool run on a file from the project and removal.
A delivery is removed only with a reason. Its files are deleted at once, and its row stays in the history: who removed it, when and why.
The room per project is limited (500 MB compressed by default); the administrator changes it in “Functions and limits”.

Personal data. Upload only pseudonymised exports, with no names or contact details, patients only by their study codes. Even such data is still personal data: keep it on the portal under an agreement with the client (a data processing agreement) and only as long as the work needs it. Remove deliveries you no longer need.