Database Design in REDCap: Summary and Assessment
Practical Exercise: Designing a REDCap Project for a Multisite Cohort Study
Exercise
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Practical Exercise: Designing a REDCap Project for a Multisite Cohort Study
Exercise
Practical Exercise: Designing a REDCap Project for a Multisite Cohort Study
### Scenario
A research team is conducting a prospective cohort study in three hospitals. The study enrolls adults admitted with severe respiratory infection and follows them for 28 days after discharge. At screening, staff assess eligibility and consent. At enrollment, they collect demographics, comorbidities, vital signs, laboratory results, and treatment information. During admission, participants may experience adverse events and may receive multiple medications. At discharge, staff record discharge status and discharge date. On day 28, study staff call participants to determine survival status, readmission, symptoms, and clinic attendance. Each hospital should see only its own participants, while the central data manager should see all records.
### Tasks
1. Choose the most appropriate REDCap project type and justify your choice.
2. List the main instruments that should be created.
3. Identify which instruments should be assigned to scheduled events and which should be repeating instruments.
4. Propose at least five validation rules for key clinical variables.
5. Provide three examples of branching logic that would improve usability.
6. Define at least four user roles and describe their permissions.
7. Explain how Data Access Groups should be configured.
8. Draft a short User Acceptance Testing plan with at least five test scenarios.
### Suggested Response Structure
Learners should prepare a REDCap design brief with sections for project type, event structure, instruments, repeating instruments, validation rules, branching logic, user roles, Data Access Groups, reports, and testing. The response should show that the learner understands how protocol requirements become REDCap design decisions.
### Instructor Guidance
Strong responses should select a longitudinal project because the study has scheduled timepoints. Learners should identify instruments such as Screening, Enrollment, Vital Signs, Laboratory Results, Treatment, Adverse Events, Medications, Discharge, and Day 28 Follow-up. Adverse Events and Medications should usually be repeating instruments because participants may have multiple occurrences. Data Access Groups should be configured for each hospital, and users should be assigned according to site. User roles should follow least privilege. UAT scenarios should include an eligible participant, a screen failure, multiple adverse events, multiple medications, a missed day 28 follow-up, a death before follow-up, and site-level access testing.