A recruitment plan turns a target such as 60 participants into numbers you can manage: how many people to reach, screen and consent, through which channels, by whom and by when. This template gives you the sections, the funnel arithmetic and a worked example, ready to adapt for a funder, an ethics submission or your own use.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Target
60
Consented
21
Screen-fail rate
36%
Behind plan
5
On plan
Slow
Behind
Ramping
Key points
Purpose
Three audiences read a recruitment plan. A funder or sponsor wants to see that the target is realistic for the budget and timeline. An ethics committee wants to see how you will approach people, what you will say, and that no one is pressured. Your own team uses it as the operating manual: who calls whom, which clinic list is checked each week, and what triggers a change of tactic.
This page is a document template. It sits alongside the patient recruitment playbook for small trials, which explains the thinking behind channels and the funnel. If you are choosing tools rather than writing the plan, see patient recruitment software for clinical trials. The plan is also an input to the budget in the clinical trial budget template and to the timeline in the protocol template.
Keep the plan short. Four to six pages is plenty for most academic and early-phase studies. Longer plans are rarely read after approval, and the point is to be able to change them when the numbers say so.
The template
Copy the left column as headings. The middle column says what the section must contain; the right column is a prompt for the tough questions an ethics committee or funder will ask.
| Section | What to include | The question it answers |
|---|---|---|
| 1. Summary | Study, population, target number, recruitment period, sites. | Can a reader grasp the plan in one paragraph? |
| 2. Eligible population | Key inclusion and exclusion criteria in plain words; where such people are found; estimated size. | How many people could qualify, and how do you know? |
| 3. Targets and timeline | Number to enrol per site and per month; start and end of recruitment; milestones. | What is the pace needed, and by when? |
| 4. Funnel arithmetic | Reached, expressed interest, pre-screened, screened, screen-failed, consented, randomised, with assumed rates. | How many people must enter the top to reach the target? |
| 5. Channels | Each route: clinic database review, referral, registry, community, advertising, social, patient groups. Owner and expected yield per channel. | Where will participants actually come from? |
| 6. Materials and wording | List of every flyer, ad, script, web page, message; version and approval status. | What will people see, and has it been reviewed? |
| 7. Approach and consent process | Who makes first contact, how, with what information, and how much time people get to decide. | Is any approach pressured or misleading? |
| 8. Inclusion and equity | Groups who may be missed; steps to reach them; language, access and travel support. | Will the enrolled group reflect those who have the condition? |
| 9. Incentives and reimbursement | Expenses, payments, timing, approval status. | Could payment unduly influence a decision? |
| 10. Screening and pre-screening process | How candidates are checked and logged; where the screening log is kept. | Can you show why people were not enrolled? |
| 11. Retention | Steps to keep people in the study: reminders, flexible visits, contact schedule. | How will you avoid losing participants after enrolment? |
| 12. Monitoring and triggers | Metrics, review frequency, owner; thresholds that trigger action. | What do you do when you are behind? |
| 13. Data protection | What contact data are held, where, for how long, and who can see it. | Are candidate details protected before consent? |
| 14. Roles and budget | Owner for each channel and task; cost lines. | Who does what, and what does it cost? |
| 15. Version history | Version, date, change, approval. | Which version was used when? |
Adapt the headings to the funder or ethics template you are given. Local regulation and ethics rules decide what must be approved before use.
Worked example
All numbers are invented to show the method. Real rates depend on the condition, the criteria and the channel; use your own site data.
| Step | Assumption | Number needed |
|---|---|---|
| Target randomised | Protocol sample size | 60 |
| Allowance for drop-out before randomisation | 5% of those consented do not reach randomisation | 63 consented |
| Screen-fail rate | 40% of those screened do not qualify | 63 / (1 − 0.40) = 105 screened |
| Pre-screen pass rate | 50% of those who express interest pass a phone check | 105 / 0.50 = 210 pre-screened |
| Response rate to first contact | 25% of those contacted express interest | 210 / 0.25 = 840 contacted |
| Recruitment period | 10 months, 4 sites | 84 contacted per month, 21 per site per month |
| Screening workload | 105 over 10 months | About 10 screening visits per month across sites |
Round up at each step and add a buffer for the slow first two months. If the numbers shock you, that is the point: better now than at month six.
Channels
List each channel with an owner and an expected share of the target, then check that the shares add to at least 100% with a buffer. Do not assume every channel works for every site. A clinic with an electronic list of patients can review it each week; a site with no such list will rely on referral and community activity.
Direct approach through the care team is usually the most efficient and the easiest to defend ethically, because the patient is approached by someone they know. Advertising widens the reach and carries more review work. In the United States, FDA has an information sheet on recruiting study subjects that says direct advertising should be reviewed by the IRB and that ads should not be coercive or promise outcomes beyond those in the study materials; check the current text and the equivalent rules where you work.
A simple version for the plan:
Contacted
840 people reached
Interested
210 expressed interest
Pre-screened
105 passed a phone check
Screened
105 screening visits, 42 screen failures
Consented and randomised
63 consented, 60 randomised
In the free sandbox you can set up a screening form, test site-level numbering and try QR-code enrolment, so your plan describes a process you have already rehearsed.
How to use it
Translate inclusion and exclusion criteria into questions a clinic list or a phone check can answer. Estimate how many people qualify at each site.
Use the worked example. Take screen-fail and response rates from previous studies or site data, and state where each number came from.
Each channel has one named owner and a review frequency. Check that the plan fits within staff time; E6(R2) 4.2.2 expects the investigator to have enough time for the trial.
Wording, version, approval status. Do not use unapproved materials. See the IRB submission checklist.
Decide in advance what happens if the site is below 70% of plan for two months: a call, extra support, a new channel, or an added site.
Record changes and approvals. Material changes may need ethics notification, so check the rules that apply.
In Capture
Capture is an all-in-one clinical trial platform, so the recruitment numbers can sit with the study data instead of a separate spreadsheet. Participants can enrol through site-specific or study-specific QR codes with no app install, site-level participant numbering keeps counts separate by site, and a separate site coordinator portal lets sites work without seeing the whole study. By-site filtering and exports give you the monthly figures your plan asks for.
Now recruiting
Sleep and Recovery Study
A 12-week study of sleep quality after surgery. Takes 5 minutes a day on your phone.
Check if you can take partScan to join
Print it on posters and clinic flyers
Before submission
Same numbers as the protocol and funding application.
Each rate has a stated source or is marked as an assumption.
And a review date.
And approval status. Nothing live that has not been approved.
First contact by the care team or an approved route; time to decide is built in.
Language, travel, disability, groups at risk of exclusion.
Monthly review, by site and by channel.
Staying on plan
Compare plan with actual every month, by site and by channel, and by step in the funnel. If screening volume is fine but screen failures are high, the problem is the pre-screen. If interest is low, the problem is reach. If consented numbers are fine but randomisation lags, look at the time between consent and baseline. Each pattern has a different fix, and a single enrolment total hides all of them. A forecast helps: the enrolment forecast calculator projects the end date from current pace.
Retention belongs in the same conversation, because a participant who drops out is a participant you have to recruit again. See participant retention strategies and the clinical trial pre-screening tools overview for the front of the funnel.
A recruitment plan is the document that sets out how many participants you need, where they will come from, who will approach them, with which approved materials, and how progress will be monitored. It turns a target into a funnel with numbers and owners.
Eligible population, targets and timeline, funnel arithmetic, channels with owners, materials, approach and consent process, inclusion and equity steps, incentives, screening process, retention, monitoring triggers, data protection and version history. The table on this page gives the sections.
Ethics committees review recruitment procedures and materials such as advertisements; ICH E6(R2) 3.1.2 lists them. Whether they want the whole plan or only the materials depends on the committee, so check its requirements.
Divide your target by one minus the expected screen-fail rate, after allowing for drop-out before randomisation. For 63 consented and a 40% screen-fail rate you need about 105 screened. Then work back through pre-screening and contact response rates.
The playbook explains strategy and trade-offs. This is the fill-in document that records your decisions, numbers and owners for approval and day-to-day use.
Often reimbursement or compensation is allowed, but amounts and timing must be reviewed so payment does not unduly influence consent. Follow your ethics committee and local rules, and state it in the plan.
Monthly is a common rhythm, by site and by channel, with predefined triggers for action. Review sooner during the first two months when numbers are small and changes are cheap.
Capture supports enrolment through QR codes, site-level participant numbering, a site coordinator portal and by-site exports. It does not run advertising campaigns; you plan and approve those yourself.
Keep exploring
Patient recruitment playbook for small trials
The strategy behind the plan.
Patient recruitment software
Choosing tools.
Screening and enrollment log template
Where the funnel is recorded.
Enrollment forecast calculator
Project the end date.
QR code participant enrollment
Enrol without an app.
Participant retention strategies
Keeping people in.
Clinical trial budget template
Cost the plan.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.