Protocol Translation and CRF Design: Summary and Assessment

### Scenario A research team plans a prospective cohort study of adults presenting to outpatient clinics with suspected respiratory infection. The study objective is to determine whether baseline oxygen saturation predicts hospitalization within seven days. Participants will be enrolled at three clinics. At enrollment, staff will record demographics, symptoms, oxygen saturation, respiratory rate, temperature, comorbidities, and whether the participant was referred to hospital. Follow-up will occur by phone on day 7 to determine whether the participant was hospitalized, recovered, still symptomatic, lost to follow-up, or died. The principal investigator asks the data manager to design the first version of the CRFs and data dictionary. The statistician notes that the primary outcome is hospitalization within seven days, and that the analysis will adjust for age, sex, clinic, baseline oxygen saturation, respiratory rate, temperature, and comorbidity status. ### Tasks 1. Identify the primary outcome and at least three secondary or supporting variables. 2. Create a small protocol-to-variable mapping table with at least eight variables. 3. Draft a data collection matrix showing which variables are collected at enrollment and which are collected at day 7 follow-up. 4. Propose clear variable names and labels for oxygen saturation, respiratory rate, temperature, hospitalization status, and follow-up date. 5. Identify at least three validation rules that should be applied in REDCap. 6. Identify two fields that should use coded options rather than free text. 7. Explain how CRF version control should be handled if the study later adds a day 14 follow-up. ### Suggested Response Structure Learners should prepare a short design document containing three sections. The first section should summarize the objective, primary outcome, and key variables. The second section should include a table mapping protocol requirements to variables, forms, source documents, and timepoints. The third section should describe design decisions, including coding standards, validation rules, missing value handling, and version control considerations. ### Instructor Guidance Instructors should encourage learners to justify each variable. A strong response should avoid collecting unnecessary data while ensuring that the primary outcome and adjustment variables are fully supported. Learners should be reminded that hospitalization status should not be captured only as a free-text note. It should use structured coded options, with date of hospitalization captured separately if required. Oxygen saturation should include units or percent notation, a plausible range, and guidance on whether room air or supplemental oxygen status should be recorded. If a day 14 follow-up is added, learners should recognize that this is a protocol and CRF change requiring version control, communication to sites, possible database modification, and documentation of the effective date.