research-protocol

Research Protocol Skill

Produces structured research protocols for academic, clinical, social science, or market research studies.

Required Inputs

• Research type (clinical trial / observational / qualitative / systematic review / survey)
• Research question or hypothesis
• Setting and population
• Proposed methodology
• Timeline
• Funder or institution (if applicable)

Output Structure

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Research Protocol: [Study Title]

Version: 1.0 | Date: [Date] | PI: [Name, institution]

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1. Background and Rationale

• What is already known
• What the gap in knowledge is
• Why this study is needed now

2. Research Objectives

Primary: [One clear answerable question or hypothesis]

Secondary: [Additional questions]

3. Study Design

• Design: [RCT / cohort / qualitative / mixed methods]
• Setting: [Where]
• Duration: [Total period and recruitment window]
• Rationale: [Why this design fits the question]

4. Participants

Inclusion criteria: [List]

Exclusion criteria: [List]

Sample size: [n] — Basis: [Power calculation or saturation rationale]

Recruitment: [Method and source]

5. Methodology / Intervention

For interventional: intervention description, control, randomisation, blinding

For observational/qualitative: data collection methods, tools, data collectors

6. Outcomes / Measures

Primary outcome: [Measure], assessed by [method], at [timepoint]

Secondary outcomes: [Measure], [method], [timepoint]

7. Data Management

• Storage: [Where and anonymisation method]
• Access controls: [Who can access]
• Retention: [How long]

8. Analysis Plan

Quantitative: [Statistical test], [missing data handling], [software]

Qualitative: [Framework — e.g. Braun & Clarke], [quality assurance]

9. Ethical Considerations

• Ethics approval: [Body / reference]
• Informed consent: [Process]
• Confidentiality: [How maintained]
• Risk to participants: [Assessment and mitigation]

10. Dissemination Plan

• Target journals: [2-3 relevant]
• Conference presentations
• Public/patient summary

11. Timeline

| Phase | Activities | Start | End |

|---|---|---|---|

| Setup | Ethics, approvals, tool development | | |

| Recruitment | | | |

| Data collection | | | |

| Analysis | | | |

| Write-up | | | |

Quality Checks

• [ ] Primary objective is singular and answerable (not compound)
• [ ] Sample size has a stated basis (power calculation or saturation rationale)
• [ ] Ethical considerations section is complete
• [ ] Analysis plan is pre-specified (not "to be determined")
• [ ] Timeline includes all phases from ethics approval to write-up

Anti-Patterns

• [ ] Do not write an analysis plan as "to be determined" — the analysis approach must be pre-specified before data collection
• [ ] Do not skip the ethical considerations section — all research involving human participants requires ethical review
• [ ] Do not define research questions so broadly that the study cannot answer them within scope and budget
• [ ] Do not conflate the research question with the hypothesis — state them separately and clearly
• [ ] Do not omit sample size justification — an underpowered study wastes resources and produces inconclusive results

Example Trigger Phrases

• "Write a research protocol for [study]"
• "Help me design a study to investigate [question]"
• "Write the methodology for my research proposal"