The protocol (or synopsis) is the most consequential document of your residency: it is reviewed by your guide, the scientific committee and the institutional ethics committee (IEC), and once approved it becomes a contract — your final thesis is evaluated against what you promised here. Here is each component, with what reviewers actually look for.
1. Title
Specific, self-explanatory and honest about the design: "A hospital-based cross-sectional study of vitamin D deficiency among patients with type 2 diabetes mellitus attending a tertiary care centre." Avoid abbreviations and question marks.
2. Introduction and need for the study
One to two pages: the burden of the problem (global → India → your region), what is known, what gap remains, and why your setting matters. End with one explicit sentence beginning "Therefore, this study was planned to…" — reviewers look for it.
3. Aims and objectives
One aim, stated broadly. One primary objective — specific, measurable, matching your sample size calculation. At most two or three secondary objectives. Every objective must have a corresponding method, a planned analysis and (eventually) a results table.
4. Brief review of literature
For the protocol, 1–2 pages and 15–25 key references suffice — the full 60–80 reference review comes in the thesis itself (see our RoL guide). Prioritise the study you cite for your sample size assumptions.
5. Materials and methods — the heart of the protocol
- Study design: name it precisely — use our Study Design Finder if unsure.
- Study setting and duration: department, hospital, and the data-collection window.
- Study population with explicit, unambiguous inclusion and exclusion criteria. ("Age > 18 years, diagnosed T2DM on treatment for ≥ 6 months" — not "diabetic patients".)
- Sample size with justification: formula, assumed values, cited reference study and dropout allowance. This is the most-queried item in IEC meetings — our free calculator writes this paragraph for you.
- Sampling method: consecutive, simple random, systematic — name it and say why.
- Data collection procedure: step-by-step, including who collects what, with which instrument, at which visit.
- Study tools: name validated scales with citations; attach your proforma as an annexure.
6. Statistical analysis plan
Name the software (SPSS version/R), the descriptive statistics, the normality test, and the specific tests per objective — our Statistical Test Chooser helps. A protocol that says only "appropriate statistical tests will be used" invites a query.
7. Ethical considerations
Informed consent process, confidentiality measures, risks and benefits, and a statement that the study will begin only after IEC approval. Attach the consent form and patient information sheet in English and the local language.
8. References, proforma and annexures
Vancouver style, numbered in citation order. Attach the proforma, consent forms, information sheets and any validated questionnaires.
Why protocols get rejected
| Mistake | Fix |
|---|---|
| No sample size justification | State formula, assumptions and cited reference — generate it here |
| Objectives don't match methods | Map each objective to a method and an analysis before submitting |
| Vague inclusion/exclusion criteria | Make every criterion measurable and unambiguous |
| Missing consent documents | Attach consent form + information sheet in English and local language |
| "Appropriate tests will be used" | Name the exact tests per objective |
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