YouEDC Capture

Scanning drug packs and devices

The DataMatrix of a drug pack or the UDI of a device read from a photo: the product, the INN, the batch and the expiry date in the eCRF without typing.

A concomitant drug or a device is written more accurately from its pack than from memory. The pack scan reads the code printed on the pack: the DataMatrix of a drug (Russian labelling under Decree 1556, the European FMD) or the UDI of a medical device. From the code the eCRF fills the product, its INN, the batch and the expiry date. Nothing is installed: the photo is read by the browser itself, a 2D scanner types the code into the field, and the digits printed on the pack can be typed by hand.

The code names a product and a batch; the serial number of one pack is not needed by the study.

Setting up the form

In the eCRF builder, open a text field for the code and choose Pack scan: the code of the pack (DataMatrix). In the same form, give the fields it should fill their roles: the product from the code and the INN from the code (text), the batch from the code (text) and the expiry date from the code (a date). Each role is taken by one field per form, and none is required: a form may keep only the code. The demo studies have it in Concomitant medication: the code field sits under the drug's name, which takes the INN.

Scanning at a visit

The code field has a Photo of the code button. On a phone it opens the camera; on a computer it takes a picture file. Hold the pack flat and close, so that the code is sharp. A 2D scanner works in any browser: it types the code into the field and presses Enter, and the portal reads it instead of sending the form. When the browser cannot read a photo (some browsers lack the reader), the page says so and the scanner or the typed digits remain.

The portal checks the GTIN's check digit and the dates, and shows what it read under the field. The other fields fill by themselves and can still be corrected by hand. What the form keeps is (01)GTIN(10)batch(17)expiry: the serial number of the pack and its crypto elements are left out, and the portal does not query the national track and trace system (МДЛП).

The study's list of products

Products by pack code keeps the products by GTIN. The manager or the data manager uploads a list (Excel or CSV, with the GTIN and the name; the INN, strength, form and manufacturer are optional) or corrects one product in the table. A GTIN the list does not know yet is named once by the site team, right under the code field, and every next scan of that pack fills the product at once. The page shows which fields take part, how many times each product was scanned and where it came from; CSV downloads the list.

The audit trail

Every product named, uploaded or corrected is a record in the audit trail with its GTIN, who did it and when. The value in the form has its own history like any other field. Whoever enters data in the study can name a product; the monitor and the viewer only read the code.