Patient files

All the files the sites uploaded into the eCRF in one place: what is expected, the check for personal data, the reading of images by central readers.

The Patient files section gathers in one place every file the sites uploaded into the patients’ forms: DICOM studies, photos and PDF from the fields of the type “Files and images”. The documents of the Trial Master File and of the site file are not here: only what the doctor attached to the patient’s eCRF. Everyone sees the files by their rights: the patients of their sites, without the forms hidden by blinding. Rejected and withdrawn files are seen by the site and by those who close queries.

What the widgets show

• Files: how many files stand in the forms (accepted and on check), for how many patients, their size and kinds.
• Required files expected: required file fields in the forms of visits that took place or whose window has opened, with no file. A form saved complete expects no file: it has the file, a “no data” mark, or the field is hidden by its condition. A field shown on a condition is expected only once the form is saved. The tab Expected, not uploaded lists them, overdue visits first, each with a link to the form.
• On check for personal data: photos, PDF and ultrasound wait for a data manager or a monitor to make sure the picture shows no patient’s name. While a file is on check, only the site and they see it.
• Image reading and Readers differ: when the study has central reading (see below).
• Rejected and withdrawn: with the reasons; a rejected file’s contents are deleted, its record and audit lines stay.

The list of files

One line is the files of one field at one visit of a patient: a CT series of three hundred slices is one line with the number of files, the modality and the size. The line shows the state of the personal data check, of the reading and of the form itself (draft, complete, verified by SDV, approved, locked). List unfolds the file names with links to the viewer; the visit’s name leads to the form. The marks “study date outside the visit window” and “sex differs from the patient card” come from the DICOM checks at the upload.

Filters: patient ID, site, field, kind, status and reading. Register (Excel) downloads the list by the filters: every file with its SHA-256, who uploaded and checked it and when, a sheet of the reading and a sheet of the expected files. Files (ZIP) gives the files themselves that you may open, in folders site / patient / visit / form; the site team (its sites), those who export the study’s data and the central readers (their images) download files in bulk. Patients who withdrew the use of their data stay out of the downloads. Every download, every opening of a file in the viewer and every file downloaded go to the audit trail.

The lab and medical documents that forms were filled in from have their own pages: links to them with the number of documents stand above the list.

Central reading of images

The project administrator or a data manager chooses for each file field in the block Central reading of images at the bottom of the section: not read, one reader, or two independent readers, an adjudicator when they differ. The readers are invited to the team with the role Central image reader: they see only the files of the chosen fields, released from the check for personal data, and nothing else about the patients; blinding holds.

1. The reader opens Image reading in the menu: it shows what waits for their read. Read opens the set.
2. The viewer in the browser is for orientation, not for diagnosis. When the protocol asks for a diagnostic workstation, Download the set (ZIP) gives the DICOM files without the patient’s identity.
3. The reader marks the image quality and the result (within normal limits; abnormal, not clinically significant; abnormal, clinically significant; not evaluable), writes the findings and saves. A read is never changed and goes to the audit trail with their name.
4. In double reading the second reader does not see the first one’s result until the set is decided. If they agree, the set is read. If they differ, the set waits for the adjudicator: a third reader who sees both reads, chooses the result and must write why.

Reading starts once every file of the set is released from the check for personal data. If the site later adds or withdraws a file, the set is read again: the earlier reads stay in the set’s history, marked that the files have changed since.