Consent from home, a tablet at the site, a safer sign-in

YouEDC Capture

• ePRO on the site’s tablet. The site pairs its tablet with the study by a one-time code on the new page “Site tablets” (from “ePRO adherence”); pairing signs out of the portal in the tablet's browser, and the tablet never keeps a team member’s access. In the patient’s card a team member presses “Hand over” next to the tablet: the tablet shows the patient’s code and the team member’s name to check, and after “Start the questionnaires” only this patient’s open questionnaires, one question per screen, with the same checks as on the phone. “Finish”, 5 minutes without a touch, “Take back” in the card or a handover to another patient send the tablet back to its lock screen, which shows nothing about the patient. The answers stay the patient’s own; the form shows that they came from the site tablet and who handed it over, and the audit trail keeps every handover and the end of each session with its reason. Patient questionnaires (ePRO)
• My studies: a working study and its QA environment are now one card with a Production | QA switch. The black stripe and Open production mean real patients, the orange one and Open QA test data. The environment whose team you are not in is greyed out with a lock and no link. The count, the search and the status filter count the study once.
• Patient files. A new section of YouEDC Capture gathers in one place every file the sites uploaded into the patients' forms (DICOM, photos, PDF), by each person's rights and without the forms hidden by blinding. Widgets on top: how many files, how many required files are still expected at visits that took place or whose window is open (with a list and links to the forms), how many are on check for personal data, the reading of images, rejected and withdrawn. Each line shows the personal data check, the reading and the form's status (SDV, approval, lock). A register in Excel and the files themselves in a ZIP by folders; every download, opening and file download goes to the audit trail. Central reading of images: a field is read by one reader or by two independent readers with an adjudicator when they differ; the new role Central image reader sees only those images, a read is never changed and goes to the audit trail. Patient files · Files and images in forms
• Remote electronic consent (eConsent). The project manager adds to a consent version the text approved by the ethics committee and questions on understanding; once saved, the text never changes, and its SHA-256 fingerprint is on the page. The investigator creates a link and a 6-digit code on the patient's page (shown once, the portal keeps only their fingerprints) and gives them to the patient in two different ways. The patient enters the code, reads the text, answers the questions (a wrong answer shows the explanation), can ask the doctor to call or decline, then signs: the full name, the code again, a handwritten signature if they like. The investigator checks the patient's steps and countersigns with their password; the consent is recorded with the date the patient signed, and the same link keeps the patient's copy with both signatures as PDF. Five wrong codes close the link for 15 minutes; every step is in the audit trail, and the patient's name never goes into the audit trail or exports. Remote electronic consent · Informed consent
• Forms in several languages. The eCRF builder has a Languages page: the forms' source language and up to eight translations (Russian, English, Hebrew, Arabic, German, Kazakh and others) with a table of how much of each form is translated. Only texts are translated: questions, hints, units, answer options, the form's name, the messages of checks and the visit names; the codes of fields and answers do not change, so exports and statistics do not depend on the language. The patient chooses a language at the top of the ePRO page (or the site, in the patient card), Hebrew and Arabic are shown right to left, and a questionnaire opens in the patient's language only when it is translated in full. The language of the answers is kept with the time and the device. A translation is part of the eCRF: after a release it waits in the draft until the next version, a reworded question marks its old translation as out of date, and every change goes to the audit trail. A licensed questionnaire (EQ-5D, SF-36) takes only the owner's official translation with its source, and the locked texts of a scale lock its translations. For a language the portal does not speak, the study also translates the buttons of the patient's pages Forms in several languages
• A study's validation package. Every study has its own package: the client's validation plan and summary report, the eCRF specification, the UAT scenarios and protocol, the traceability matrix and the release note of the version, all from the eCRF and the UAT runs. The platform's package the study relies on is shown alongside. “Send to the TMF” files each document in the study's eTMF; sending again changes only the documents that changed. Validation package
• Signature and lock of a single form. The signature settings get a third choice, “Every form”: the investigator signs a saved form on its page or from the Signatures list, and a change of the form's data withdraws the signature. “The whole patient” and “Every visit” stay. The new page Form locks: the data manager locks forms by a filter (visit, form, site, patient; clean, approved or all) with a reason such as “Interim analysis 1”, or one form on its page. Nobody changes the data of a locked form: not from the browser, an import, the API or ePRO; queries, SDV and signatures go on. Unlocking needs a reason, every step is in the form's audit trail. Lock of single forms · Investigator electronic signature
• Actions on event. The form's page in the builder, under its checks, gains rules “when the form is saved and the condition holds, then…”. The condition is the same as for checks: fields of this and other forms, the site, sex, the enrolment date. The first action sends the patient a questionnaire of an event “On event” a set number of days after the save or after a date of the form (“7 days after discharge”), open for the days set and repeated as many times as set. It appears on the patient's ePRO page, and the e-mail reminders come as usual. The second action opens a query to the site on a field of the form with its own text, such as “Serious event: send the SAE report within 24 hours”. When a correction makes the condition no longer hold, the action withdraws itself: the query is closed and a questionnaire not yet sent leaves the patient's page. Every run and withdrawal is in the patient's audit trail, and the page “Actions on event” shows what was sent to whom. An action works on new saves and reaches the QA environment at once Actions on event · Patient questionnaires (ePRO)
• A read API. A manager who may export the data makes a key that reads, or writes and reads, and the sponsor's warehouse, a CTMS or a statistics program takes the patients, the saved forms with their values and table rows, and the queries of its sites. The answer comes in pages, with filters by patient, site, visit, form and status, and updated_since gives only the changes since the last load. The key sees what the export gives: no forms for the unblinded team and no patients who withdrew the use of their data, no e-mail, date of birth or initials. Every read is logged (key, call, filters, rows), the last reads are on the API page. All the calls are described in OpenAPI 3.1 at /api/v1/openapi.json. API for hospital, laboratory and sponsor systems
• ePRO without the internet and as an app. The patient's link can go on the home screen: an icon called “Questionnaires”, with no study name. On a phone the patient calls their own, the questionnaires open now and in the next 7 days are kept; without a connection the patient answers, the answers are encrypted with the server's key at once and sent by themselves when the internet is back. The server accepts them only if, by the phone's clock, the questionnaire was filled in within its window, not before the copy was made and not more than 7 days ago. If the connection drops while an ordinary questionnaire is being sent, the answers are kept too. The form's record says “filled in without the internet” with the phone's time. The patient's phone as an app: without the internet and with notifications
• ePRO notifications on the phone. The patient switches them on after the PIN: when a questionnaire opens and on its last day. A notification is empty, with no study, questionnaire or data. The delivery service is chosen by the browser (Google, Apple, Mozilla), so the function is off by default: the admin switches it on once the lawyer agrees. The site sees on how many phones notifications are on and can switch them off; a new link switches them off by itself. The patient's phone as an app: without the internet and with notifications
• Data from any medical document. Every form has “Fill in from a medical document”: a discharge summary, a test report, a conclusion or an outpatient record as a PDF or a photo. Rules find what doctors write the usual way (“АД 142/88”, “вес”, the dates of the stay in one sentence, the ICD-10 code after the diagnosis, conditions in a list and their negation), and the local language model, which reads free text too, will be switched on after the move to the production server. The model's value is taken only when its quote stands in the document. The investigator ticks each value, next to its quote and the piece of the photo; the audit trail says “proposed by the machine (rules / local model) from document MD-n, checked by the investigator”. No outside AI service: the model may run only on the installation's own server or private network, every call is logged with the model's fingerprint, and the text itself is not kept Data from a medical document