Repeating groups of fields, remote SDV and inspectors

YouEDC Capture

• Repeating groups of fields in a form: the site adds a block of fields for each record (earlier lines of therapy, lesions, relatives), the fields stand one under another, a long text may be among them, and a field can be shown on a condition inside its own block. A ready-made group “Previous lines of therapy” with the regimen, dates, best response and why it stopped. A block is deleted with a reason; checks, queries, SDV, the audit trail and the export are those of a growing table, and a growing table becomes a group and back. The type 2 diabetes demo has earlier glucose-lowering therapy in the medical history eCRF builder
• A note on a field without a query. The site, the monitor or the data manager explains a value, for example “the patient fasted only 6 hours” or “the value confirmed by phone with the lab”, and nobody has to answer it. The note shows under the field to everyone who opens the form, and on the new Notes tab next to the queries. It changes neither the data, SDV, the approval nor a signature, and can be written on a locked form too. A note is never edited or deleted: its author withdraws it with a reason, and everything goes to the audit trail. Notes are in the export (the Notes sheet) and in the casebook. The demo studies have notes of the sites and the monitors Notes on fields · Entering data into a form
• Remote SDV by copies of source documents: the site uploads to a visit copies of documents with the personal data blacked out and confirms it with a box, the monitor compares the forms with them from the office. The copies are deleted once the visit is verified, by the monitor's button or by the study's limit (30 days), and a copy where a name shows is deleted at once. Only the site and the monitors open copies, every opening is in the audit trail; the data manager, the sponsor and the export never see them Remote SDV by copies of source documents