A study from its protocol, lab results from the laboratory's PDF, site statistics in YouEDC Trials

YouEDC Capture

• Lab results from the laboratory's PDF. A form with lab results has the button “Fill in from the lab's PDF”: the investigator uploads the PDF the laboratory sent and sees each row of the form next to the document's line. The laboratory's own names (“Alanine aminotransferase (ALT)”) are found by themselves, a result in mg/dL is converted into the form's mmol/L or µmol/L, and the value is checked against the range and arrow on the sheet itself (a lost decimal comma shows at once). The investigator ticks doubtful values one by one, then confirms that it is the patient's document and when the sample was taken; the form is filled in, but the investigator saves it as usual, and each value has the document in its history. If the sex or year of birth in the document differs from the card, the page warns. A name the investigator matched by hand once is remembered for the site (the lab profile). The PDF is not stored: the result lines and the file's fingerprint stay. The “Lab documents” page shows the data manager the documents and the share of corrections by site. A demo study has a report of the invented “Демо-Лаб”. No AI Lab results from the laboratory's PDF or a photo
• An eCRF amendment and the data already collected. The “Run the draft over the working data” button on the versions page checks every saved page of the changed forms twice, with the version in force and with the draft, and shows by site: new errors, completed forms that will need adding to, new automatic queries and the queries that will close. The run only reads: data and queries stay as they are, one line goes to the audit trail. After the release completed forms stay completed and keep their SDV mark, and the forms without a new required field go to the list “To add after an amendment” of their sites. In both demo studies the eCRF is released as version 1 at the launch, an amendment a month ago added the required “Neck circumference”, and the draft of version 3 narrows the expected blood pressure range QA environment of a study
• A study from its protocol. Upload the protocol as DOCX or PDF (New study → “Set up from the protocol”), and YouEDC Capture sets the study up from it: the visits with their days and windows from the schedule of activities, the forms from the form library, the study profile, the test environment with the draft published to it and the protocol in the TMF inbox. The auto-setup log says row by row what was done, what was done on an assumption, what to set up by hand and what needs a licence, quoting the protocol and its page; contradictions between sections (the age range in the synopsis and in the criteria, say) are shown on their own. While rows “to check” and “contradiction” wait for a decision, version 1 of the eCRF is not released, and every decision goes to the audit trail. No AI: the same file always gives the same set-up, and the log keeps the SHA-256 of the file and the version of the rules. Try it on the training protocol YE-330-302 (type 2 diabetes, 10 visits, two contradictions left in on purpose): the study is your demo and is deleted in one click. The Create a study button of Protocol to study build now does the same A study set up from its protocol · Protocol to study build