Site payments, medical review and data entry without the internet

YouEDC Capture

• Scheduled data delivery: a plan says what goes to whom (the statistician, the DSMB, the medical monitor), de-identified or as it is, in Excel, CSV, SPSS, Stata, SAS XPT or R, daily, weekly or monthly; the recipients in the team get a letter with a link and download the file on the portal, or the file and its “.sha256” go to their SFTP server (the server's host key is checked and pinned, internal addresses are closed, data as it is goes there only with a second confirmation). The delta export: only the rows added or changed since the previous delivery, a sheet of changes with the old and new value and the reason from the audit trail, and the rows removed. Each run freezes a data cut, the file is kept with its SHA-256, all in the audit trail; the demo has a weekly delta to the statistician and a monthly file for the DSMB. SDTM is not part of the delivery yet Scheduled data delivery and delta export
• Bulk data change requests (DCR): the data manager prepares one change of a field for many records, chosen by visit, site and the value now, and sees the list before making it. Each site compares its records with the source documents and confirms them as a batch or rejects single ones with a reason. Only confirmed records change, each with the request number in the audit trail; a record that changed in the meantime is not overwritten Bulk data change requests
• Visit reminders to the patient: a few days before the window of a planned visit opens, the patient gets one SMS or e-mail with the dates of the window only, with no name, study or site, through the channel already set up for ePRO. The study manager switches them on and chooses how many days before; each reminder shows in the patient's calendar, the study's list and the audit trail Visit reminders to the patient
• YouEDC Capture: medical review. The new medical monitor role reads the adverse events, lab results outside the normal range (L/H) and therapy of every patient on live data in three listings, marks lines reviewed one by one or many at once and raises medical queries to the site. A line the site changes after the review comes back; serious events come first; Excel; every mark and query is in the audit trail. In the demo study the medical monitor has already done two reviews Revue médicale
• YouEDC Capture: outcome adjudication. The new endpoint committee member role classifies the study's events blinded to the treatment: two members review each event independently without seeing each other's review, a third decides with a required reason when they differ. An event changed by the site is read again, the earlier reviews stay in its history. The event forms and the charter's categories are the study's; Excel; all in the audit trail. In the demo a committee of three cardiologists meets every week Outcome adjudication
• YouEDC Capture: biosample tracking. The site registers each tube by its barcode with the patient, the visit, the sample type and the time of collection, packs the tubes into a shipment to the central laboratory with the storage temperature, the courier and the tracking number, and prints the manifest. The data manager records the receipt and the condition of each tube, and the laboratory's file is reconciled with the tubes: unknown barcodes, another patient, shipped but not received, no result. Tubes kept at the site for over a week show at once; all in the audit trail. In the demo the sites ship every week, one site is late Biosamples
• Data entry without the internet, the first step: for a district hospital or a home visit. The investigator marks their own device and, before the outing, keeps empty copies of the simple forms of the chosen patients on it. Without the internet the forms are filled in as usual and wait on the device encrypted; when the internet is back and they sign in, they go to the server. A form that got data meanwhile is never overwritten: the investigator chooses the values field by field. The audit trail names the device and its time for each value; a lost device is revoked Data entry without the internet
• YouEDC Capture: the DM assistant on the local language model of the installation's own server; no data leaves it. “Ask the study”: a question in words, in Russian or English (open queries by site, forms not entered after visits, visits out of window, who waits for SDV, enrolment against the plan and more); the model only picks one of the safe questions, and the portal counts the answer itself for your sites and blinding, with links into the eCRF and how it counted; without a model keywords read the question, and every question is a button. “Review a patient”: the model reads the patient's data and proposes inconsistencies across forms and visits, quoting the stored values, with a draft query; a proposal with a value the patient does not have is dropped. You open the query or dismiss the proposal with a reason, and the audit trail records the model's call. The demo has a past patient review DM assistant on the local model
• Double data entry from paper CRFs: for registries, post-authorisation and academic studies on paper. The study chooses the forms typed twice. A second operator, never the one who saved the form, types the same paper form into an empty copy without seeing the first entry. The differences go field by field to the data manager, who looks at the paper and takes the first or the second value with a comment; the second value corrects the form through the normal save with a reason. A value changed by the site after the decision is compared again. In the demo the data managers type two forms again every week, with typos and decisions Double data entry