Why write it first
The protocol is the operational contract for the study. It allows ethics/governance reviewers, collaborators and statisticians to evaluate what will be done before the results influence decisions.
Protocol structure
- Title page: title, short title/acronym, version, date, PI, sponsor/institution, collaborators.
- Synopsis: design, setting, population, exposure/intervention, comparator, primary outcome, duration.
- Background and rationale: what is known, the gap, why this study is needed.
- Objectives/hypotheses: one primary objective and prespecified secondary objectives.
- Study design: exact design and conceptual framework.
- Setting: facilities, departments, recruitment/data period.
- Participants: inclusion/exclusion, screening, recruitment, consent.
- Variables/interventions: operational definitions and timing.
- Outcomes: definition, measurement method and time point.
- Sample-size rationale: assumptions, power/precision or feasibility justification.
- Data sources and collection: CRF/extraction form, source documents, quality checks.
- Bias and confounding: anticipated risks and mitigation.
- Statistical/qualitative analysis: primary model/method, covariates, missing data, sensitivity analyses.
- Data management: identifiers, storage, access, retention, sharing, destruction.
- Ethics and governance: approvals, consent/waiver request, privacy, vulnerable groups, safety.
- Monitoring and amendments: deviations, adverse events where relevant, protocol changes.
- Dissemination: authorship, publication, registration, data sharing.
- Timeline and roles: milestones, responsible person, dependencies.
Mediclinic Middle East publicly states that research projects carried out at MCME are to receive approval from its internal Research and Ethics Committee and applicable local regulatory authorities before initiation. The exact route varies by project, facility and emirate. Dubai projects may involve DSREC depending on applicability. This hub must therefore route users to the Research Office and current local forms rather than declaring a project “ethics exempt.” Institution-specific forms and contacts will be inserted after verification.
Version-control rule
Every approved protocol should display a version number and date. Never overwrite the approved copy. Save amendments as new versions and retain a change log showing what changed, why, when and whether approval was required.
Protocol completion checklist
- Primary objective and outcome fixed.
- Eligibility operational.
- Sample-size assumptions recorded.
- Data dictionary/CRF attached.
- Analysis plan specific enough to execute.
- Privacy/storage route approved.
- Consent/waiver route described.
- Roles/timeline assigned.
- Version/date on every protocol page.
Attachments that should exist before submission
- Data collection form / case report form or survey instrument.
- Data dictionary with definitions and coding.
- Statistical analysis plan when the analysis is complex enough that one paragraph in the protocol is insufficient.
- Participant information sheet and consent form for participant-facing research.
- Recruitment materials and interview guides where applicable.
- Investigator brochure/device information or intervention manual for trials when required.
- Full search strategy for evidence syntheses.
- Budget/resources and study timeline if required by the institution.
- Data-management/security plan and data-sharing plan where applicable.
Protocol quality test
- A new team member should be able to determine exactly who is eligible without asking the PI.
- A data collector should know exactly where every variable comes from and how it is coded.
- A statistician should be able to identify the primary analysis without seeing the results.
- An ethics reviewer should be able to understand every participant/data interaction and privacy risk.
- Any future amendment should be identifiable by comparing two version-controlled protocols.