Formulas in the eCRF, DSUR, Kaplan–Meier and RWE tools

YouEDC Capture

• Validation and archive of a study. On the new page Validation and archive (the last section of the study settings and a button on the eCRF versions page) every released eCRF version has its validation kit as one ZIP: the specification, the DVP of that very version, the signed snapshot, the changes, the UAT scripts and results with the executor's and the approver's signatures, the traceability, the release record (whether exactly what was tried was released) and the audit trail of the QA environment, every file with its SHA-256. The UAT scripts download as a blank sheet in PDF and Excel to run them on paper. The archive of the whole study is built in the background in ZIP volumes of up to 2 GB and is read without YouEDC: every eCRF version, the data in ODM, Excel and CSV, the data cuts, the casebooks by site, the audit trail with its chain check, the signatures, the team, the validation kits, the files and DICOM when asked. Before the database is locked the archive is marked interim; building it and every download go to the audit trail, and the admin's page that deletes a study for good shows whether its archive was built and downloaded Validation kit and study archive · QA environment of a study
• Why the data is as it is. An unscheduled visit may ask why the patient came: planned follow-up, worsening or new symptoms, an administrative reason, or other with a note; the site gives the reason with the visit date, and the audit trail keeps every change. A “no data” mark may say why the value is missing: not measured in routine practice, measured but not in the medical record, the patient refused, not applicable, unknown. The export has VISIT_REASON on the Events sheet and a sheet of the “no data” marks with their reasons, the export builder puts <VARIABLE>_NDREASON next to <VARIABLE>_ND, and the data quality report counts the missing values of each variable by reason and the unscheduled visits by why the patient came. A de-identified cut keeps the reason codes and drops the free text. In the demo some patients come to unscheduled visits, and the missing values have reasons Entering data into a form · Events, the patient timeline and the visit calendar · Data quality report · Data export · Export builder and formats for statistics
• The organisation's form library. A form finished in one study can be proposed to the library of the organisation with “Propose to the library” on the form's page: as a new form or as the next version of one already adopted. A steward of the library (an admin of the organisation or a person the admin names) sees the fields and what changed against the last version and approves the version with an electronic signature over its SHA-256, or rejects it with a reason; with two stewards nobody approves their own version. Approved forms are offered in the Form library of the builder of every study of the organisation and stay linked to the library like the YouEDC standard forms: what the team changed and whether a newer version is out. A form can be retired, another organisation never sees the library, every step is in the audit trail. The demo has an invented sponsor's library with a form you approve yourself. Form library, copying and eCRF from Excel
• Visit document for the medical record. The doctor fills the registry visit once, and under the visit on the patient card there is a Document for the medical record (PDF) button: an A4 examination note with the site, the visit date, the visit's forms as readable sections, the records since the previous visit and the doctor's signature line. The doctor writes in the full name, date of birth and medical record number by hand: the portal does not keep them. The forms for the unblinded team are never printed, and the randomisation arm is not read. The study chooses the forms and the title of each visit, for example “Discharge summary”. The document is signed by hand, and every printout goes to the audit trail with the SHA-256 of its content Document for the medical record
• The patient sees their own data in ePRO. The study picks up to six variables (numbers from repeated visits and the patient's questionnaire scores) and switches My data on, and the site's investigator approves it for each patient on the patient card. On the personal link the patient sees a chart and the values with dates, checked ones only: the form is complete and no query is open on the value. There are no norms, no red or green, no comparison with others and no interpretation; forms that could reveal the treatment arm are never shown. A fixed note asks to discuss the values with the doctor, and “How your data helps” says how many patients take part. Switching on, approving and withdrawing go to the audit trail; the diabetes and hypertension demos have it on The patient sees their own data (ePRO)
• Form packs by disease: type 2 diabetes, arterial hypertension, chronic heart failure and chronic kidney disease. The library has 19 new forms: diabetes history, a log of hypoglycaemia by level, complications, the summary of continuous glucose monitoring; hypertension history, office blood pressure of three readings with the mean, 24-hour monitoring, a home blood pressure diary for the patient, organ damage; heart failure history and phenotype with a check of the ejection fraction, NYHA, echocardiography, NT-proBNP, congestion, the six-minute walk, a log of heart failure events; kidney disease history and categories, kidney function and electrolytes, a log of kidney replacement therapy. Each pack is the forms of the disease with visits for a year: choose it as the template in the new study wizard or add it to a study with “Add the pack” in the form library of the builder; the forms the study already has do not come twice. Form library, copying and eCRF from Excel · eCRF builder
• Pack scan of drugs and devices. A code field in the eCRF reads the DataMatrix of a drug pack (Russian labelling under Decree 1556, the European FMD) or the UDI of a medical device: from a phone photo (read by the browser itself, nothing installed), a 2D scanner or the digits typed by hand. The portal checks the GTIN's check digit and the dates and fills the product, INN, batch and expiry date in the same form. The product of a GTIN comes from the study's list: the data manager uploads it from Excel or CSV, or the site names a new product once at its first scan. Only the GTIN, the batch and the expiry date are kept; the pack's serial number and crypto elements are left out, and the portal does not query МДЛП. In the demo studies the packs of the background drugs are scanned, with invented trade names Scanning drug packs and devices
• Formulas in the eCRF. A calculated field can now compute a free formula, the way a spreadsheet does: SQRT(HEIGHT * WEIGHT / 3600), IF(SMOKER = 1, CIGS * YEARS / 20, 0), DAYS(AE_START, AE_END). An “if - then” check can be written as a formula too, with the field the query or the error goes to: “SBP - DBP < 20 AND PATIENT.SITE = "01"”. A formula names the fields of this and other forms and the patient's card, which now has the site number: a field, a check or a visit can apply at some sites only. The builder checks the formula as it is typed, shows it in words, refuses what the form may not name or a circle, and values of a test patient typed under the formula show the result at once. A formula is a small language of its own that the portal reads and never runs as a program; the browser and the server compute alike, changes of formulas and calculated values go to the audit trail, and the DVP shows the formulas with the form codes Data entry checks · eCRF builder · AND / OR conditions and checks across forms