Recruitment Configuration
Set each country's patient target, enrollment window and recruitment pattern so the forecast knows when patients arrive.
Recruitment is step 2 of the trial wizard. For every country you added in Country and Depots, you set how many patients will enroll, when enrollment opens and closes, and the shape enrollment follows over that window. This is the demand signal behind every forecast: kits are only needed once patients arrive.
Use this step for your planned enrollment. Enrollment that has already happened belongs on the trial's Actuals page, which the forecast reads alongside this plan.
Before you begin
- Add at least one country in step 1, Country and Depots. Until you do, the step shows Countries Required with a button back to step 1.
- Set the number of sites for each country in step 1. The site count appears on each country card, and the Patient/Site/Month input needs it.
- The Site strategies pointer appears only when Site Shipments is on for the trial. Site activation is available for every trial.
How the step is laid out
From top to bottom, the step shows:
- Recruitment Curve — a chart previewing enrollment over time. Filter it to one country or All Countries, and switch between Absolute and Cumulative.
- A toolbar with Enrollment defined at, Recruitment type and Region, plus running totals for Countries, Total Patients and Total Sites. With more than one country, Expand All / Collapse All opens or closes every card.
- Study defaults — trial-wide dates that countries fall back to.
- Patient Enrollment — one card per country (or per region, if you group countries). Collapsed cards show the date range, patient count and site count; a card missing patients or dates shows an amber edge and Set dates.
Changes save automatically as you edit.
Choose where enrollment is defined
Enrollment defined at sets whether recruitment is planned once for the trial or separately for each cohort.
| Option | What happens |
|---|---|
| Study (default) | You plan recruitment per country on this step. Patients are then distributed across treatment arms and cohorts using the allocation you define in later steps. |
| Cohort | Each cohort recruits independently, with its own enrollment plan. This step becomes read-only and shows Enrollment is managed by the Cohorts step; you set dates and patients for each cohort in the Cohorts sub-step under Treatment. |
Choosing Cohort also turns on the Cohort dimension if it was off. Turning the Cohort dimension off later resets enrollment to Study.
Note: Cohort is not available for multi-cycle trials. Prognosis shows "Cohort-level enrollment is not available for multi-cycle trials." and keeps Study.
Choose a recruitment type
Recruitment type controls what the patient target on each card means.
| Type | Patient target means | Extra field |
|---|---|---|
| Enrollment (default) | Enrolled patients per country. | None |
| Screened | Screened patients per country. | Screen Failure % on every card |
In Screened, the forecast uses enrolled patients: screened patients minus screen failures, rounded. Each card shows the result, for example "Forecast will use 80 patients after 20% screen failure", and the collapsed card shows both Screened and Enrolled counts.
Switching from Screened to Enrollment clears every country's screen failure percentage. If any country has a screen failure percentage, Prognosis asks you to confirm first, and the change cannot be undone. Switching the other way needs no confirmation.
Configure a country
- Expand the country's card in Patient Enrollment.
- Enter the Target Patient Count, or a rate if you use Patient/Site/Month (see below).
- Set First Patient In (FPFV, the date enrollment opens in the country) and Last Patient In (LPFV, the date enrollment closes).
- In Screened, enter the Screen Failure %.
- Under Recruitment Pattern, pick how patients arrive over the window.
Country fields
| Field | What it does | Notes and validation |
|---|---|---|
| Target Patient Count | Total patients to recruit in the country. | Required. Must be between 1 and 99,999. With the Monthly pattern it is the sum of the monthly counts and can't be typed. |
| First Patient In | Date enrollment opens (FPFV). | Required. |
| Last Patient In | Date enrollment closes (LPFV). | Required. Must be after First Patient In: "Last Patient In date must be after First Patient In date". A country with no date of its own takes the study default (see below). |
| Screen Failure % | Share of screened patients who fail screening. | Screened only. 0 to 100. |
| Recruitment Pattern | Shape of enrollment between the two dates. | Required: "Please select a recruitment pattern to continue." |
Enter a rate instead of a total
Above the patient field, switch between Total Count and Patient/Site/Month. The choice applies to every country card.
With Patient/Site/Month, enter patients per site per month (decimals allowed). Prognosis calculates the target as rate × sites × months between First Patient In and Last Patient In, rounded to a whole patient, and shows the working, for example "1.5 × 4 sites × 12 months = 72 patients". It needs the country's site count from step 1 and both dates; until then the card tells you which is missing.
The toggle is hidden when the country uses the Monthly pattern.
Recruitment patterns
| Pattern | Shape | Suited to |
|---|---|---|
| Monthly | You enter the exact number of patients for each month. | Enrollment plans that are already known month by month. |
| Standard | Symmetric bell curve: gradual ramp-up, peak in the middle, gradual ramp-down. | Most trials with standard site activation. |
| Slow Start | Left-skewed curve: a long ramp-up with the peak later. | Complex protocols, regulatory delays or hard-to-reach populations. |
| Fast Start | Right-skewed curve: rapid early enrollment, then a gradual decline. | Established sites or urgent recruitment. |
| Linear | Constant rate across the whole window. | Sites with steady, predictable patient flow. |
Reshape a curve
For Standard, Slow Start and Fast Start, a Recruitment Curve panel appears below the patterns once the card has both dates and a patient count. It shows the patients expected in each month.
- Click the chart to add a control point, and drag a point to reshape the curve. Hover a month to see its patient count.
- Hover a point to reveal its delete button (available when there is more than one point).
- Select Reset to return to the pattern's default shape. Picking a different pattern also resets the curve.
A pattern you have reshaped shows a dashed border.
Note: If the country has recruitment actuals, those months are locked to the actual numbers ("N months locked from actuals"). The curve spreads the remaining patients across the other months.
Plan month by month
Choosing Monthly opens Monthly Recruitment Breakdown:
- Set First Patient In and Last Patient In, then select Generate Monthly Grid from Dates. You get one cell per month, grouped by year.
- Type a Patient count in each month, or enter a value in Patient Count: and select Fill All (every month) or Fill followed by a year (every month in that year).
- Use Delete All to clear the grid, or the delete control on a year to remove that year. Only the first or last year can be deleted.
When you change the dates, the grid adjusts to the new range and keeps the values you already entered; Update Grid regenerates it on demand. The target patient count is the sum of all months, and a Patient Recruitment Forecast chart shows the period, total and monthly average.
Months before the current month are read-only and show 0. Record past enrollment on the Actuals page instead.
Note: The Monthly pattern needs at least one month in the grid before you can continue.
Copy one country's setup to others
- On the source country's card, select Copy to ... (or the copy icon on a collapsed card).
- In Copy recruitment config, pick the target countries.
- Select Copy to followed by the number of countries, for example Copy to 2 countries.
The target countries receive the source country's patient target, dates, recruitment pattern, curve shape, monthly breakdown and screen failure percentage. Each target keeps its own region membership.
Group countries into regions
Regions let several countries share one recruitment setup. A region appears as its own card in Patient Enrollment and as its own series in the chart.
- In the toolbar, select Add Region.
- Enter a Region name and tick its Countries. A country that already belongs to another region can't be selected.
- Select Add Region.
On a region card, you set one Target Patient Count, First Patient In, Last Patient In, pattern and, in Screened, Screen Failure % for the whole region.
- The patient target is split evenly across the member countries, with any remainder going to the first countries. For example, 100 patients across 3 countries become 34, 33 and 33.
- A monthly breakdown is split evenly the same way, month by month.
- Dates, pattern, curve and screen failure apply to every member.
To change a region, open it with its edit button: rename it, change its countries and select Save Changes, or select Delete region. Deleting a region moves its countries back to the main list without changing their recruitment settings.
Regions are available with either Enrollment defined at option. With Cohort, they group the enrollment lines you set in the Cohorts sub-step.
Set study defaults
Study defaults sits above the country cards and holds dates that apply to the whole trial.
| Field | What it does | Notes |
|---|---|---|
| Last patient in | The trial-wide last patient in date. | Any country or region without its own Last Patient In takes this date. A country that sets its own date keeps it; select Use study default under its date to follow the study again. While unset, the field shows the latest country date. |
| All sites active by | The trial-wide date by which every site is active. | While unset, it shows the latest country First Patient In. |
A study Last patient in must come after the first patient in date of every country that would take it.
Plan site activation
Site activation is available for every trial. With Site Shipments on, each site gets its own initial shipment when it activates. With Site Shipments off, each site's seed ships when the site activates, or when the country first needs the kit if that is later. Leave every site active from the first patient in, the default, and the seed ships all at once, as it always has.
Each country card (and each region card) gets a Site activation panel that spreads the country's sites over an activation window:
- Set All sites active by, or use Or set it to to pick 3 mo, 6 mo or 12 mo after the first patient in, or LPI. Leaving it unset uses the study default, or the first patient in date if there is none.
- Review Sites activating per month. Sites are spread evenly across the window; type a different number in any month to move sites there. A month you change is held at that number; release it to spread its sites again.
- Optionally turn on Individual site dates and type over a site's date to pin it. The other sites re-space around it.
Reset returns the country to the study defaults. All sites must be active by the country's Last Patient In.
Changing a country's first or last patient in date can move its activation dates. Prognosis shows This also changes site activation, where Change both dates applies both, or Keep or adjust site activation? when the new first patient in date falls after the country's All sites active by date, so you can choose Keep site activation or Adjust site activation.
With Site Shipments on, the Site strategies card below the countries has two buttons: Open Site Strategies, where you group sites by how fast they enroll, and Site Shipments.
Continue to the next step
Continue is available once every country has a valid target, both dates in the right order and a recruitment pattern. If something is wrong after you have started editing, Please fix the following issues lists the problems. An error in the site activation plan also blocks Continue.
With Enrollment defined at set to Cohort, there is nothing to fill in here and Continue moves straight on.
Related guides
- Countries and depots — add countries and set their site counts before planning recruitment
- Cohorts and titration — define enrollment per cohort when Enrollment defined at is Cohort
- Treatment arms — allocate enrolled patients to arms and set dropout rates
- Actuals — record enrollment that has already happened
- Shipments — DNx cut-offs and the site shipment settings used when Site Shipments is on