Trial Kits

A kit is a packaged supply of medication, placebo or supporting material that a patient receives at a visit. The Kits step (step 3 of trial setup) is where you define every kit your trial dispenses. Later steps build on these definitions: treatment arms dispense kits at each visit, label groups and production plan lots of each kit, and every forecast, inventory and cost figure is counted in kits.

See Study setup for an overview of all setup steps.

Add a kit

1. Open the Kits step. A trial with no kits yet starts with one kit, New Kit, ready to fill in. (If the step shows no kits, click Add Your First Kit.)
2. To add more kits, click the + button (Add kit) at the end of the kit tab bar.
3. Fill in the kit's fields (see Kit fields). Each kit has its own tab; the tab shows the kit name, or "Kit 1", "Kit 2" and so on if the name is blank.
4. Repeat for every kit in the trial, then click Continue.

Each kit you add is named New Kit 1, New Kit 2 and so on, and starts with an amount of 1 tablet, a shelf life of 1 month, no cost and US dollars as the currency. It has no kit type until you choose one, and the kit shows "Please select a kit type to continue." until you do.

Tip: Drag kit tabs to reorder them. The new order is saved automatically.

Kit fields

Each kit's Primary tab has six sections: Basic Information, Quantity Details, Dose Strength, Expiration Details, Pricing Details and Administration Details.

Basic information

Quantity details

Note: Amount describes what is inside one kit, not how many kits you need. Prognosis forecasts the number of kits from your recruitment, treatment and visit schedule.

Dose strength

Dose strength is used to calculate dispensed quantities automatically in the Titration sub-step. Leave it blank if your trial does not use titration.

Expiration details

Shelf life sets how long each lot of the kit remains usable after manufacture.

Pricing details

Administration details

Administration records how the kit is given to patients: On site (administered at the site) or Take-home. Prognosis pre-selects it from the unit type — Vial, Ampoule and Injection pre-set to On site; every other unit type except Other pre-sets to Take-home. Hover the info icon next to the label to see whether the current value came from the unit type or from your choice. A choice you make is kept even if you later change the unit type.

When Site Shipments is on for the trial, administration also sets the kit's DND (do not dispense) default, and:

• Administration is required for every kit. If any kit is missing it, the step shows "Site Shipments needs an administration method for every kit." with the kits to fix, and Continue stays disabled. This only happens for kits with unit type Other that you have not answered.
• An Effect on DND button opens a read-out of the kit's current DND, DNC (do not count) and DNS (do not ship) values. By default, DND is the longest interval between two visits (including visit windows) for a take-home kit, and 3 days for an on-site kit. Click Open DNx Settings to change them.

Note: Effect on DND and the required-administration check appear only when Site Shipments is on for the trial. With it off, Administration is still shown but optional, and your choices are kept when you switch. See Site Shipments add-on.

Configure secondary packaging

Secondary packaging is optional. Use it if your team tracks inventory in boxes or cartons rather than individual kits. Analytics then includes a Secondary Packaging Summary for the trial.

1. In the kit's panel, click the Secondary (Optional) tab on the right. A dot on the tab shows whether packaging is configured.
2. Turn on the switch in Secondary Packaging Configuration. Prognosis starts you with one level, a Box that holds 10 kits, laid out in a 2 × 5 grid.
3. Under Packaging Hierarchy, set each level's Package Level Name (for example Box, Carton or Pallet) and Quantity. The first level contains Kits; each level you add with Add Packaging Level contains the level before it. The summary under each level reads, for example, "1 Box = 10 Kits".
4. Under Box Layout Configuration, set Number of Rows and Number of Columns (1 to 20 each), then click cells to mark where kits sit. Use Fill All or Clear All to fill or empty the grid.

The first level's Quantity should match the number of filled cells. If it does not, the step shows how many cells are missing or extra and offers a link to set the quantity to the filled count; this does not block Continue. If the quantity is larger than the grid can hold, increase the grid size or reduce the quantity.

To remove secondary packaging, turn the switch off.

Set local sourcing and availability

Each kit has an optional Local sourcing / availability card below its fields. Click Configure to open it.

Locally sourced kits

Select Locally sourced for a kit that is supplied locally, outside the central supply chain. Prognosis packages no kits and creates no lots for it, and assumes unlimited local supply.

1. Under Sourced in, select the countries where the kit is sourced locally, or leave them all unselected to source it locally everywhere.
2. For each selected country, optionally set Per-country settings:
   • End date — No end — always local, Ends on date (pick a date), or Ends after FPI (a number of days, weeks or months after the country's FPI; available once the country has an FPI date). After that point, the kit is supplied through the clinical supply chain in that country.
   • Local cost / kit — the kit's cost while locally sourced. Leave it blank to use the kit's Cost Per Kit.

Limited local availability

Select Limited local availability to restrict where the kit can be dispensed, then choose countries under Available only in. You must choose at least one country but not all of them, and the trial needs at least two countries. To cover the remaining countries, pair this kit with another kit in the dispensing rules in later steps; the forecast then uses the right kit for each country.

Copy settings between kits

When the trial has two or more kits, a Copy to ... button appears in the kit's header.

1. Open the kit whose settings you want to copy and click Copy to ....
2. Review the summary of settings that will be copied, and select the kits to copy to.
3. Click Copy to n kits (the button counts the kits you selected).

Copying replaces every setting on the selected kits except their names, including kit type, country availability, local sourcing and packaging. It cannot be undone. If the source kit's administration was never answered, each target keeps its own.

Load and save kit templates

Use the step's template actions to reuse kits across trials:

• Load kit… — pick a saved kit template, then choose Add as new to add it as a new kit or Replace to overwrite the currently selected kit's settings. Other kits on the trial are not affected.
• Save kit as template… — save one or more of this trial's kits as templates. A kit needs a name and a kit type before it can be saved.

See Master data for managing saved templates.

Delete a kit

1. Click the × on the kit's tab (Delete kit).
2. Confirm with Delete Kit.

Deleting a kit cannot be undone. Treatment arms are kept, but the kit is removed from their dispensing and from every later setting that refers to it.

Add cost details

Below the kits, the optional Cost Analysis card tracks trial costs beyond the cost per kit. Click Configure to open Additional Cost Details.

• Charges — supply-chain charges for the trial. Click Add Charge and choose a Charge Type: Accountability & Destruction, COG, Courier Costs, Data Management Services, Depot Management, Distribution Management, Packaging & Labeling Costs, Per Unit Fees, Pick and Pack Costs, Project Management Fees, Project Management Materials, QP Services/Release Costs, Secondary Packaging, Storage Costs, Study Setup Costs or Other.
• Other Charges — patient- and site-level charges: Cost per Patient, Cost per Site or Other.

Every charge has:

Use Load costs… to replace all current charges with a saved cost template or the account's Fixed Costs catalog, and Save costs as template… to reuse this trial's charges. Cost details feed the Cost Analysis tab in Analytics.

Saving and continuing

Kit changes save automatically about 1.5 seconds after you stop editing, and the wizard's save indicator shows the status. A kit tab with a problem shows a red dot.

Continue stays disabled until:

• The trial has at least one kit.
• Every kit has a name, a kit type, an amount, a unit type and a shelf life.
• Kit names are unique ("Kit names must be unique. Please ensure each kit has a different name.").
• Every kit with a cost has a currency, and every kit with unit type Other has a custom unit name.
• Local sourcing and limited availability selections are complete.
• With Site Shipments on, every kit has an administration method.

Related guides

• Countries and depots — the network your kits move through.
• Label groups — group countries that share kit labeling.
• Treatment arms — dispense kits at each visit.
• Cohorts and titration — where dose strength drives dispensed quantities.
• Production constraints — plan lots of each kit.