YouEDC Biostat, the sixth section of the portal; “Save and send for review”; website texts for the six sections

YouEDC Capture

• YouEDC Biostat is the sixth section of the portal: a tab in the left menu and its name in the header. The section's first page shows the YouEDC Capture studies where you are the manager, a data manager, the statistician or the sponsor's viewer: patients, sites, randomised, by arm or blinded, whether the variables were chosen, the Report and PDF buttons. A study's report opens in the section's colours. In both demo studies (diabetes and hypertension) every chart is there right after creation: enrolment, taking part, age and sex, the key variables over the visits, the change from baseline, adverse events, safety variables, and the PDF YouEDC Biostat: the study's statistics by itself
• Data entry in YouEDC Capture: the main button of a form reads “Save and send for review” (in a study without SDV, “Form complete”). The label is changed in the eCRF builder, Data entry section, in Russian and in English; the change goes to the audit trail. After saving, the next form of the same visit opens (the patient's ePRO forms are skipped), after the last one the patient card at the next visit. If the form opened an automatic query, the investigator stays on it and sees which field the query is on Saisir les données dans un formulaire · Constructeur d’eCRF
• Tables in a form now reach the export, the casebook PDF and CDISC ODM. Each table has its own sheet (a file in the CSV): a line per test or record, with the row's code, unit and normal range, like the LB domain. A grid's values are also on the form's sheet, a column per cell (LBORRES_GLUC). In ODM a table is a repeating group. The casebook prints a table as a table, with the deleted rows and the reasons; the investigator's signature covers the cells too Export de données · Casebook du patient (PDF) · Constructeur d’eCRF
• The test environment of a study in YouEDC Capture: a linked copy of the study for test patients (a code like REG-DIAB-01-TEST, an orange frame and the TEST badge). The eCRF draft is published to it as a candidate without a signature, the test patients stay from version to version, and the working study releases the same snapshot with the same SHA-256 and records “tried as candidate N” in the version. A release without the test needs a tick and the reason. While the study is being set up, patients are enrolled only in the test environment, so the working study starts with no test patient. Test data never reach the exports, YouEDC Biostat, counts or letters QA environment of a study · Versions de l’eCRF
• ePRO: a screen pack for the ethics committee. In the eCRF builder, the “ePRO screens for the ethics committee” button gathers every patient screen from the eCRF in force, in order: the PIN, the list of questionnaires, each question with its answers and codes, the check before sending, the reminder letters and the unsubscribe page. A PDF/A in Russian or English for the ethics committee and the scale's owner. And time travel: while the study is being set up (and in demo projects), a test patient's ePRO calendar moves 1, 7 or 28 days ahead, to see questionnaires open and close, reminders go out and the adherence board change; the time stamps of answers stay real Questionnaires patient (ePRO)
• The lab table of a form takes the site's ranges from the Lab normal ranges page: by the patient's sex and age and the visit date, converted into the row's unit (mg/dL into mmol/L). The site's range replaces the builder's expected range: it opens the query and gives the L / N / H flag in the form, the export (the NRIND column) and the casebook PDF. Calculated rows: eGFR by CKD-EPI 2021 and LDL by Friedewald fill in by themselves when the form is saved. The ranges page is in YouEDC Capture studies too Saisir les données dans un formulaire · Constructeur d’eCRF · Valeurs normales de laboratoire
• Demo studies: the lipid panel is a table in the form, with the sites' laboratory ranges (one site reports in mg/dL), L / H flags and LDL by Friedewald Projet de démo