Protocol

Research

A detailed written plan for a study, fixed in advance — increasingly registered publicly (pre-registration) to separate confirmatory from exploratory findings.

Sources

1. ICMJE Recommendations — Clinical Trial Registration icmje.org accessed 22 September 2026

Public registration of a study plan in advance is a formal requirement in clinical research. The International Committee of Medical Journal Editors requires registration of clinical trials in a public registry “at or before the time of first patient consent for enrollment”, and gives the reason first: to “prevent selective publication and selective reporting of research outcomes”. Registration after the fact cannot do that job, which is why the rule is prospective.

The ICMJE requirement governs clinical trials. Pre-registration in other fields follows the same logic by convention rather than by that rule; the broader usage in the definition above is this lexicon’s.

Related terms

• Abbreviation
• Abstract
• Abstraction
• Academic Database
• Analysis
• Annotation

From the AJG lexicon archive (July 2026).