What Is a Research Protocol?
Looking for the full method? Read the detailed guide: What Is a Clinical Research Protocol?.
A research protocol is a written plan that describes why a study is being done and exactly how it will be carried out, analysed and monitored. It is the reference against which readers and ethics committees can judge whether the study followed its plan.
Example
A protocol for a chart review states eligibility criteria, the primary outcome, the variables to be collected, how missing data will be handled and who will analyse the data. If the outcome changes later, the change is recorded as an amendment.
Common misunderstanding
A protocol is not the same as a proposal: a proposal persuades a funder, while a protocol is a detailed operating plan. Nor is it a document you can write after seeing the data.
Learn more
Read the full guide: What Is a Clinical Research Protocol?
References and further reading
- Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207. doi:10.7326/0003-4819-158-3-201301080-00007
- International Committee of Medical Journal Editors (ICMJE). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Link
Related reading
This page is general educational information about research methods. It is not medical, legal or regulatory advice; follow your institution's ethics board and your target journal's instructions.