YouEDC Supply

The study drug from the depot to the patient: setup, shipments and receipt, dispensing on the visit form, the site's shelf, the movement of kits.

YouEDC Supply is the sixth section of the portal: the study drug of a YouEDC Capture study from the depot to the patient. Batches, shipments to the sites, receipt, quarantine, resupply, kits dispensed at the visits and returns. Every movement of every kit goes to a journal that cannot be changed. A blinded study stays blinded: the blinded team sees kit numbers and expiry dates only.

The system is not validated. Before use in a real study the customer validates it. For explanations, contact the developer: contact@youedc.com.

The Movement screen of a demo study: where the kits are now, the depot with its kits by expiry date and every site's shelf with a 90-day chart.

Where to find it

The YouEDC Supply tab in the left menu lists all your studies with a supply. Inside a study it is the “YouEDC Supply” menu item. The manager, data manager, investigator, monitor, viewer and supply manager see the section. An investigator limited to their sites sees only those sites' shelves. The supply manager (the “Clinical supply manager” role) or the manager keeps the depots and shipments; in a blinded study they also need the unblinded flag in the team.

Setting up the supply

The Setup page goes step by step. Kit types: what is in a kit and for which randomisation arm; kits of all types look the same and the label carries a blinded name. A depot. Batches with their expiry: a batch is released by someone other than the person who added it (the qualified person), and only a released batch goes to the sites. Give comparable batches of different types the same expiry. The kit list: numbers run in a row and the types are mixed in blocks, so a number tells nothing about the contents. The dispensing schedule: at which visit, how many kits and on which form the button is. Last come the settings: how many days before expiry a kit is not dispensed, the storage temperature, the delivery time, the resupply levels.

Shipments and receipt

A site is opened for supply when it is ready (contract, ethics, initiation visit): the first shipment brings each kit type up to its maximum. Then the system resupplies the site by itself: when the stock minus the kits for the patients' coming visits falls below the trigger, a shipment is prepared. Kits leave the depot by expiry: what expires first goes first, with a margin for the delivery and the shelf. The supply manager sends the shipment with a waybill, the site receives it kit by kit and marks what is damaged or missing. If the logger shows a temperature out of range, the kits go to quarantine until the supply manager decides. Every night expired kits are taken off the shelves.

Dispensing at the visit

On the form of a visit from the dispensing schedule the investigator sees the “Kits to dispense” block: which numbers to take from the shelf. The system chose them by the patient's arm, the expiry and the site's stock, at random among kits of the same expiry. The Dispense button records it. A damaged or lost kit is replaced by another, and a kit the patient brings back is recorded with the units left in it. When no suitable kit is there, the system does not say which kind is missing: that would tell the arm.

The block on the visit form: the patient's kit numbers, the dispense button and the return of earlier kits.

The site's shelf

The site card shows the doctor how many kits can be dispensed, what is on its way, how many were dispensed since the site opened and what needs attention: quarantine and kits close to expiry. The chart shows the shelf over 120 days. Below are the kits on the shelf with their expiry, a folded list of the kits returned by patients, the site's shipments and the latest movements. The supply manager changes the resupply levels here and can resupply the site at once.

The site's shelf as the doctor sees it: four numbers and a 120-day chart of the shelf.

A kit's way and the journal

A kit number opens its passport: where it is now, when and to whom it was dispensed, what came back, and its whole way from the kit list to the patient with dates and people. The Journal tab shows every movement of every kit, newest first. Journal rows are never changed or deleted; the database itself refuses to edit them.

The kit passport: from the depot to the site, quarantine after a temperature excursion, the manager's decision, dispensing and return.

Blinding

Blinded members see kit numbers, expiry dates and totals. Kit types, batch numbers and counts by type are for unblinded members only. The audit trail records kit numbers and places, never a type, a batch or an arm. Kit numbers are shuffled, and the choice among kits of the same expiry is random.

Not there yet

Returns to the depot and destruction, batch recall, dosing by weight, transfers between sites, a barcode scanner, labels and Excel export are planned for the next stages. Russian drug track-and-trace (MDLP) is not supported, and narcotic and psychotropic drugs are not kept in the section.