Recruitment and retention are often discussed as separate performance measures. For the participant, they are one experience. The expectations set during an initial conversation influence whether screening feels manageable, whether follow-up visits fit everyday life and whether concerns are raised before an appointment is missed.
During feasibility, sponsors and CROs can examine that experience before asking a site to commit to a number. The aim is to understand how people move through the study, where delays are likely and what the team will do when a promising referral does not become a completed visit.
Where will potential participants actually come from?
A list of channels is not yet a recruitment plan. Practice records, physician referrals, community outreach and advertising each require different work. Ask which pathways are active for the proposed population, who manages them and what has to happen before a person can be approached.
For a referral pathway, ask whether the referring practice understands the key study requirements and how questions return to the investigator. For an existing patient population, ask how current clinical information will be reviewed. For advertising, ask who will handle responses when they arrive and whether the staffing plan matches the expected activity.
FDA's recruitment guidance describes IRB review of recruitment methods and materials, including direct advertising. Plans should allow time for the applicable review and use the approved materials. A proposed campaign should not be counted as an available source of participants before the necessary steps are complete.
What happens after someone expresses interest?
An inquiry can stall without anyone formally deciding to stop. A person may be waiting for a call while the recruiter assumes the coordinator will follow up. A referral may lack relevant treatment history. A scheduled appointment may be held before the clinical team has enough information to assess whether screening is appropriate.
Ask the site to explain the next action at each stage, using an anonymous example rather than identifiable patient information. Who contacts the person? Who requests records through the appropriate process? Who reviews the clinical information? Who schedules the visit? Who notices when an expected response never arrives?
WCR's recruitment and retention approach separates outreach, records readiness, scheduling, screening and enrollment. The sponsor's question should be whether each handoff has an owner and an observable completion point. A single label such as 'in recruitment' conceals too much to support useful troubleshooting.
How will the team discuss the real visit burden?
A participant may be interested in the study and still find the visit schedule impractical. The difficult appointment may be an early morning blood draw, a long observation period, a procedure requiring an escort or repeated visits during a working week.
Ask how the team will explain those requirements before screening. The discussion should include likely visit duration, preparation, travel, time away from work, caregiving arrangements and any additional appointments outside the research clinic. Avoid assuming that an available calendar slot is a workable appointment for the person attending.
Then distinguish what can be adjusted from what cannot. Scheduling within an allowed window is different from changing a protocol requirement. If the sponsor offers transportation or reimbursement, confirm how it works and when it becomes available. Staff should be able to explain the actual arrangement without promising support that has not been approved.
What does bilingual support cover in practice?
Translated materials are one part of communication. Sponsors should also ask who can answer questions, discuss visit preparation, arrange follow-up and route clinical concerns in the participant's preferred language.
Consider the full sequence of contact. An initial Spanish-language conversation can be undermined by English-only reminders or unclear instructions from an outside provider. Ask how the site coordinates those handoffs and checks understanding, particularly when the visit requires fasting, medication documentation or travel to another facility.
These questions are relevant across WCR's South Florida and Puerto Rico network. The public workflow describes English- and Spanish-language communication and practical scheduling support. For any proposed protocol, the sponsor and site should confirm the specific materials, personnel and services needed.
How will retention be measured fairly?
A completion percentage is difficult to interpret without a denominator and a clear endpoint. Ask whether the figure describes all randomized participants, participants who began treatment, those who completed treatment or those who completed follow-up. These populations may differ.
Separate missed visits, treatment discontinuation, withdrawal from the study and loss to follow-up. A participant who stops investigational treatment may still contribute follow-up information when the protocol and consent allow it. Combining every outcome into a single 'dropout' category can obscure both the reason and the available response.
Review the timing and practical context of prior losses rather than treating one percentage as a guarantee. A short vaccine study, a long obesity study and a procedure-heavy gastrointestinal study place different demands on participants. Historical results are most useful when the team explains what was comparable and what will require a different plan.
What support is available when plans change?
Ask how the site responds to a missed appointment, an unreachable phone number or a participant who is considering leaving. A useful answer identifies the responsible person, the approved contact process and how medical concerns reach the investigator.
Support should help participants make informed choices and manage practical barriers. It should not pressure them to remain. FDA's payment guidance distinguishes reimbursement from participation payments and states that payment should accrue as participation progresses rather than depend on completing the entire study.
Discuss the expected reporting process as well. Sponsors need enough detail to identify recurring problems without receiving unnecessary personal information. A pattern of missed morning visits may call for a scheduling discussion. A pattern of missing outside records may require a different records workflow.
Ask for an operating plan, not just a recruitment target
Close feasibility with a small set of agreed definitions and actions. The following questions help keep the discussion practical:
- Which recruitment pathways are ready, and which still depend on setup or approval?
- What information is needed before clinical review and screening can proceed?
- Which visits are likely to create the greatest practical burden?
- Who owns follow-up when records, contact or appointments stall?
- How will screening, enrollment, discontinuation and completion be reported?
- What finding would cause the team to revise the recruitment estimate?
Connect feasibility to the participant experience
The resulting plan should explain both how people enter the study and how the team will support them afterward. This is also a useful way to review patient-access assumptions: a database identifies possibilities, while the operational pathway determines which possibilities can progress.
To discuss a protocol's enrollment window, participant requirements and support needs, submit a study to WCR. A realistic plan starts with the people and work behind the target.