Three examples of clinical study decisions

How to use these examples

Follow each hypothetical example from the advertised offer to the missing details, questions for the team, and next step. Use your own study’s documents to check whether the same issue applies.

Example 1: study tasks conflict with rotating shifts

Assumptions: A randomized behavioral study lists four in-person visits, thirty days of evening diary entries, two remote coaching calls, and a wearable used during two one-week periods. The participant works rotating shifts.

First impression: Four visits appear manageable.

Schedule conflicts: The diary opens from 7–10 p.m.; seven work shifts overlap the window. The wearable requires daily charging and cannot be worn during one job task. Two clinic visits begin within two hours of the participant’s daytime sleep period.

Questions: Can diary windows follow shift schedules? How are missed entries handled? Can the wearable be removed for safety equipment? Which visits can move?

Action: Ask the site to confirm the actual windows and device rule before screening. Put the seven shift conflicts and two sleep conflicts on a calendar and note any overlap. Enter active task, visit, travel, and recovery hours in the calculator.

Decision: If the diary window conflicts with required work shifts, ask whether an approved alternative exists before agreeing to screening.

Example 2: check what “up to $1,800” includes

Assumptions: An advertisement says “up to $1,800.” Consent materials list $100 for screening, $200 after each of six visits, $300 for a diary period, and a $200 completion incentive. Travel reimbursement requires preapproval.

First impression: The total amount can dominate attention.

Payment calculation: Screening plus six visits totals $1,300. The diary payment adds $300 and the completion incentive adds $200, bringing the maximum to $1,800. After screening and three visits, those completed items total $700; diary payment and the completion incentive need separate checks. In this example, travel is outside the headline and requires preapproval.

Questions: When is each amount issued? What happens after investigator removal or withdrawal? How is incomplete diary participation handled? Which travel costs need approval?

Action: Copy the schedule into the payment ledger. Ask the site to identify accrued compensation, reimbursement, incentive terms, and the IRB-reviewed completion amount.

Boundary: For FDA-regulated research, pause if the written terms make all visit compensation contingent on completion; compare them with FDA payment guidance (opens in a new tab) and raise the discrepancy with the site or rights contact.

Example 3: a remote study uses five outside vendors

Assumptions: A decentralized drug study uses a central research site, eConsent platform, home-health service, courier, wearable vendor, and electronic diary app. A recruiter asks for records by email.

First impression: Home visits reduce travel.

Record request: Each vendor may receive a different set of identifiers, clinical data, device data, or shipping details. The email request does not identify the record scope or receiving site.

Questions: Which company performs each task? Which recipients see identifiers? What permissions does the app use? How are home visitors verified? What happens to app and device data after withdrawal?

Action: Call the research site through its official number. Confirm the recruiter and the companies involved. Ask: “Which records and date range do you need, who will receive them, and which upload address should I use?” Read the participation consent and any medical-information authorization before sending records.

Boundary: Do not send records until the site confirms the recipient, scope, purpose, and channel.