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Dictionary termTrack AProposedv2026.2

Protocol paper

A peer-reviewed publication that fully describes the methodology of a planned or ongoing research study (clinical trial, systematic review, cohort study, laboratory protocol) prior to or alongside execution, sufficient to enable replication and to fix the methods against post-hoc revision.

ByCASRAI Editorial Board
· Last updated 22 Aug 2026
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Examples

Worked examples

  • Is an instance

    A published PRISMA-P systematic-review protocol registered in PROSPERO before searches began

Counter-examples

Looks similar, but isn't

  • Not an instance

    A methods section of a results paper is not a protocol paper (it is a section of a different publication type)

Editorial commentary

A protocol paper is a peer-reviewed publication that fully describes the methodology of one specific, planned or ongoing research study — a clinical trial, systematic review, cohort study, or laboratory protocol — prior to or alongside execution, in enough detail to enable replication and to fix the study’s methods against undisclosed post-hoc revision. Its defining feature is scope: a protocol paper documents the plan for a single study, not a generalisable method other researchers would adopt across different studies.

Where protocol papers are published

Dedicated venues exist specifically for this format — BMJ Open, Trials, and Systematic Reviews are established examples — reflecting that publishing a study’s protocol is treated as a citable, first-class contribution distinct from the eventual results paper. Systematic-review protocols are commonly registered in PROSPERO in addition to, or instead of, standalone journal publication; clinical-trial protocols are commonly registered on ClinicalTrials.gov alongside any published protocol paper.

How this differs from adjacent publication types

  • Versus a methods paper. A methods paper’s contribution is the method itself — a new or refined analytic technique, instrument, or computational approach intended for other researchers to adopt across their own, different studies. A protocol paper’s contribution is the pre-specified plan for one particular study; the methods it describes may be entirely standard, and its value lies in fixing them in advance for that specific study, not in the methods being novel.
  • Versus a working paper. A working paper is research circulated in progress through an institutional series, at any stage of completeness, without the pre-registration function a protocol paper serves — it is not tied to a formal commitment to a pre-specified plan.
  • Versus a Registered Report / Stage 1 protocol. A Registered Report’s Stage 1 protocol is peer-reviewed specifically for in-principle acceptance by a participating journal, with the journal committing in advance to publish the eventual Stage 2 results paper regardless of outcome. A protocol paper can exist entirely independently of the Registered Reports mechanism — published in a dedicated protocol-focused journal with no linked in-principle-acceptance commitment from the venue that will eventually publish the results.
  • Versus a methods section. A methods section embedded within a results paper is not a protocol paper — it is a section of a different publication type, written after the fact and not independently peer-reviewed or citable as its own record.

Why researchers publish protocols separately

Publishing the protocol ahead of or alongside execution serves the same core purpose pre-registration generally serves: it commits the research team publicly to a specific design and analysis plan before outcomes are known, making later deviations visible and reducing the scope for undisclosed post-hoc changes to methods or endpoints that would otherwise be invisible to readers of the eventual results paper.

References

  • Center for Open Science, Registered Reports initiative, cos.io/initiatives/registered-reports.

Also known as

Study protocol publication · Method protocol paper

Machine-readable encodings

Use in your systems

JATS XML <role> element
xml
<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="Protocol paper"
      vocab-term-identifier="https://casrai.org/dictionary/term/protocol-paper" />
Schema.org DefinedTerm (JSON-LD)
json
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  "@type": "DefinedTerm",
  "@id": "https://casrai.org/dictionary/term/protocol-paper",
  "name": "Protocol paper",
  "identifier": "https://casrai.org/dictionary/term/protocol-paper",
  "description": "A peer-reviewed publication that fully describes the methodology of a planned or ongoing research study (clinical trial, systematic review, cohort study, laboratory protocol) prior to or alongside execution, sufficient to enable replication and to fix the methods against post-hoc revision.",
  "inDefinedTermSet": "https://casrai.org/dictionary/domain/research-outputs#set",
  "url": "https://casrai.org/dictionary/term/protocol-paper",
  "sameAs": [
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    "Method protocol paper"
  ],
  "license": "https://creativecommons.org/licenses/by/4.0/",
  "publisher": {
    "@id": "https://casrai.org/#organization"
  },
  "author": {
    "@id": "https://casrai.org/#editorial-team"
  },
  "datePublished": "2026-05-21T02:04:50",
  "dateModified": "2026-08-22T13:42:37",
  "inLanguage": "en-GB",
  "isAccessibleForFree": true
}

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