YouEDC Trials for monitors, ePRO with a QR code, a CDASH form library and second-level coding review

YouEDC Capture

• The “Files and images” field in the eCRF builder: at a visit the site uploads DICOM studies (CT, MRI, ultrasound, a whole folder from a disc), photos and PDF right from the browser, in pieces that resume. DICOM tags are cleaned by the PS3.15 profile, photos lose their metadata, the original is not kept; photos, PDF and ultrasound wait for a personal data check by the data manager. A DICOM viewer in the browser (slices, window and level, zoom), the study date checked against the visit window and the sex against the card. Example files in the demo projects Files and images in forms
• A new website page about ePRO in YouEDC Capture: how the patient answers from the phone, what the site and the data manager see, how the patient’s answer is protected and what comes in the next updates. Linked from the home page and at the bottom of every page
• Investigator signature on the patient's card: for an investigator with the right to sign, the “sign again” mark leads to the usual signing page (password, meaning, statement, audit). Anyone who cannot sign (manager, monitor, administrator, investigator without the right) sees why, and the manager also gets a link to “Settings and signers” Signature électronique de l'investigateur
• In the data quality report every number opens the patients behind it: a completeness cell, the pages where the field is not filled at that site or at all of them; the cards, every gap, the outliers, the pages entered later than 30 days, the patients lost and withdrawn; from there one click to the patient or the page Data quality report
• A patient search by ID in the top bar of a study: suggestions as you type, from the start of the ID or any part of it, with the site and status; the arrows and Enter open the card, the “/” key jumps to the search; only the patients of your own sites, nothing written to the audit trail, fast with 50 000 patients Patients et matrice des visites
• ePRO: sign-in with a QR code and a 4-digit PIN (five wrong tries lock it for 15 minutes, a new link clears the PIN), a printable leaflet with the QR code in the patient card, one question per screen with a progress bar and an “All correct?” screen before sending; every answer keeps when it was opened and received, the phone's clock, the duration and the kind of device, shown to the site and the data manager on the form Questionnaires patient (ePRO)
• Medical coding, stage 2: a second-level review of the coder's decisions (a DM, the manager or the safety physician, never one's own decision, a rejection with a reason); a query to the site on an unclear term right from the queue; the organisation's decisions for all its studies; moving to a new MedDRA version with an impact analysis before the move; WHODrug Global B3 uploads; coding figures and the YouEDC Safety cases whose PT differs from the coding Codage médical
• One YouEDC form library: 47 standard forms in seven groups (CDASH core forms, laboratory, study drug, registries, questionnaires, oncology, vaccines) with CDASH variable codes, short answer codes matched to CDISC CT, texts in Russian and English and edit checks verified on test cases. The builder searches by name, question and code, filters by group and study type, previews in two languages and takes a single field into your own form. Race and ethnicity are not added with the form (152-FZ). New-study templates and “protocol → study” take their forms from the same library, and the study remembers which library version a form came from Form library, copying and eCRF from Excel