Protocol template sections
1. Administrative information
Study title; protocol number/version/date; principal investigator; co-investigators; institutions; funder; sponsor; conflicts of interest.
2. Scientific background
Rationale, literature gap, preliminary data and justification for the study.
3. Objectives and hypotheses
Primary objective and hypothesis; secondary/exploratory objectives; prespecified endpoints.
4. Study design and participants
Design, setting, eligibility criteria, recruitment, sample-size justification and withdrawal criteria.
5. Specimens and laboratory methods
Collection, processing, storage, transport, chain of identity, assay method, controls, QC thresholds, repeat rules and equipment/reagent traceability.
6. Data and statistical analysis
Variables, coding, missing-data plan, statistical tests/models, multiplicity, subgroup analyses, sensitivity analyses and software/version.
7. Ethics and governance
Consent, ethics approval, privacy, genomic-data governance, incidental findings, data sharing, sample retention and publication policy.
8. Quality and dissemination
Monitoring, deviations, audit trail, authorship, publication plan, data/code availability and record retention.
Research-use note: This resource is educational and methodological. Study-specific protocols require scientific review, appropriate ethics approval, validated laboratory methods and a prespecified statistical plan.
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