Biosamples

Tubes registered by their barcode, shipments to the central laboratory with a manifest, the receipt and the reconciliation with the laboratory's results.

Many studies send blood and urine to a central laboratory: the results come from the laboratory, and a tube that is lost, thawed or put under the wrong patient means a missing value. Biosamples follows each tube from the site to the laboratory by the barcode on its label and checks the laboratory's file against the tubes.

The Biosamples page of the demo study: a tube kept at the site for over a week is highlighted.

Who does what

• The investigator and the site team register the tubes of their patients and ship them.
• The data manager records the laboratory's receipt, reconciles the laboratory's file with the tubes and sets the sample types and the laboratories; the project administrator can do everything.
• The monitor sees the tubes and the shipments of their sites, without changing them.

Register a tube

1. Open Biosamples. The cursor is already in the Barcode field: scan the label with a barcode scanner or type it.
2. Choose the patient, the visit and the sample type, check the time of collection (it cannot be in the future) and press Register.

A barcode is 4 to 40 letters, digits, dashes, dots or underscores and is registered once in the study: a second tube with the same barcode is refused. A tube broken or spilled at the site is marked destroyed with the reason.

Ship to the laboratory

On the Shipments tab each site sees its tubes not shipped yet. Leave ticked the tubes going into the box, choose the laboratory and the storage temperature, write the courier and the tracking number and press Ship the chosen tubes. The shipment gets a number (SH-0001) and a manifest: the list of tubes to print and put in the box, or to send in Excel.

Receipt

When the laboratory confirms the delivery, the data manager opens the shipment and marks each tube: fine, haemolysed, thawed, leaked, too little, or that it did not arrive, then presses Record the receipt. The tiles on the page count the tubes at the site, on the way, at the laboratory and lost.

Reconciliation with the laboratory

On the Reconciliation tab upload the laboratory's file (CSV or Excel). It needs a column of barcodes; the patient, the date of receipt and the result are used when present. Nothing is saved; the page shows what differs:

• Another patient on the barcode: the laboratory has the tube under a different patient;
• Not known to the study: barcodes no site registered;
• Shipped, not in the file: tubes sent that the laboratory does not list;
• Received without a result and at the site for over 7 days: tubes to chase.

In a demo study the link An example file of the laboratory gives a file with typical mistakes to try it.

Settings

The sample types are written one per line as CODE|name|storage, the storage one of ambient, refrigerated, frozen, deep_frozen; the laboratories one per line. By default: serum, EDTA plasma, whole blood, urine and plasma for pharmacokinetics.

Audit trail

Every tube registered, shipped, received or destroyed is a record in the audit trail of its patient; each shipment, receipt, reconciliation and settings change too. The menu item shows how many tubes have been at the site for over a week.