Why this discipline needs its own guide
Background
Clinical-trial papers operate under additional structural constraints: prospective trial registration before the first participant is enrolled, structured reporting against the CONSORT 2010 checklist, and protocol publication under the SPIRIT framework. CRediT slots into that scaffolding rather than replacing any of it.
Authorship on trial reports is governed by the trial protocol’s pre-specified publication policy plus the ICMJE criteria. The CRediT statement records what each author did within those bounds; trial-management roles that do not meet the ICMJE bar are recorded in the Acknowledgements with the trial registration number, sponsor and funder reference.
Key considerations
How to assign the roles
- Trial Conceptualization includes the original hypothesis and the trial design as registered in the protocol. Subsequent protocol amendments do not reset the Conceptualization role.
- Methodology in a trial paper covers the study design choices: randomisation, blinding, primary and secondary endpoint definitions, statistical analysis plan.
- Investigation covers participant recruitment, intervention delivery and data collection at each site. Multi-site trials typically have multiple Investigation contributors with the optional supporting qualifier.
- Data Curation is substantive in trials: managing case report forms, monitoring data quality, locking the database. Trial data managers who are named authors hold this role.
- The trial statistician is Formal Analysis. Pre-specified versus post-hoc analyses do not change the role assignment.
- Project Administration covers the trial coordinator and operational management; Supervision covers the chief investigator and steering-committee members with oversight responsibility.
- The trial registry identifier (ClinicalTrials.gov NCT, ISRCTN, EudraCT) belongs in the manuscript metadata alongside the CRediT statement and any PROSPERO registration for a systematic review.
Reporting Guideline Integration
CONSORT 2010 & SPIRIT to CRediT Crosswalk
Mapping Clinical Trial Protocols and Reporting to CRediT Roles
Clinical trials require strict coordination across PIs, site investigators, database managers, and trial coordinators. This crosswalk aligns the CONSORT reporting standards and SPIRIT protocol guidelines with specific CRediT roles to simplify authorship attribution in interventional trials.
| Checklist Item / Phase | Mapped CRediT Role(s) | Guidance & Practical Allocation |
|---|---|---|
| Title, Abstract & IntroductionScientific background, clinical trial rationale, and objectives. | ConceptualizationWriting – Original Draft | The underlying medical hypotheses and clinical goals are Conceptualization. Drafting the initial review of previous literature belongs under Writing – Original Draft. |
| Trial Design & ProtocolParallel, crossover, allocation ratio, and trial phase structure. | ConceptualizationMethodology | Formulating clinical objectives is Conceptualization. The structural engineering of the trial design, endpoint definitions, and randomization rules belongs to Methodology. |
| Participants & SettingsEligibility criteria, recruitment locations, and collection settings. | MethodologyInvestigation | Developing the screening protocol criteria is Methodology. Recruiting patients and interviewing subjects at active clinical sites maps to Investigation. |
| Interventions & DeliveryPrecise administration details of drug, device, or sham therapies. | InvestigationResources | Sourcing, compounding, packaging, and shipping the active treatments maps to Resources. Administering treatments to trial participants is Investigation. |
| Outcomes DefinitionPre-specified primary and secondary endpoints and assessment tools. | ConceptualizationMethodology | Integrating endpoint markers with clinical utility belongs to Conceptualization. Defining measurement tools, diagnostic criteria, and timing maps to Methodology. |
| Sample Size & PowerCalculations to show clinical trial statistical feasibility. | MethodologyFormal Analysis | Designing the statistical power framework belongs under Methodology. Executing the baseline calculations belongs to Formal Analysis. |
| Randomisation & AllocationSequence generation, concealment mechanism, and enrollment implementation. | MethodologyInvestigation | Constructing randomized sequences or block allocation maps is Methodology. Implementing the random envelopes or online random triggers at clinical sites is Investigation. |
| Blinding & MaskingProcedures for masking participants, providers, and outcome assessors. | InvestigationValidation | Executing masked protocols in the clinic is Investigation. Standardized verification of outcomes by a blinded adjudication board maps to Validation. |
| Data ManagementDatabase locking, CRF data entry, and database structural monitoring. | Data CurationProject Administration | Creating schemas, entering CRF data, checking data quality, and locking databases is Data Curation. Tracking overall site compliance maps to Project Administration. |
| Statistical AnalysisIntent-to-treat (ITT) analysis and post-hoc statistical modeling. | Formal AnalysisSoftware | Executing formal statistical models, hazard ratios, and ITT datasets is Formal Analysis. Writing custom software/scripts to process clinical databases is Software. |
Worked example
A representative CRediT statement
Author Contributions (CRediT) Principal Investigator (PI), J. Akande: Conceptualization, Methodology, Supervision, Funding acquisition, Writing – review & editing. Trial Statistician, M. Hoffmann: Methodology, Formal analysis, Writing – original draft. Site PIs (P. Singh, R. González, T. Yamamoto): Investigation, Writing – review & editing. Trial Manager, S. O'Brien: Project administration, Data curation. Data Manager, L. Chen: Data curation, Formal analysis. Trial registration: ClinicalTrials.gov NCT0XXXXXXX.
The role names above match the canonical wording at casrai.org/credit. Most publishers accept exactly this format.
Further reading
Discipline-specific sources
Common questions
Frequently asked
How do I assign CRediT roles for the trial statistician?
The trial statistician is recorded under Formal Analysis. This applies whether the analyses were pre-specified in the statistical analysis plan or run post hoc — the distinction belongs in the Methods, but it does not change the role assignment. The statistician may also hold Methodology if they helped design the analysis plan.
Does CONSORT replace the CRediT statement?
No — CONSORT 2010 is a structured reporting checklist for how the trial is described, not a statement of who contributed. CRediT slots into the trial-reporting scaffolding alongside prospective registration and SPIRIT, recording each author's contribution. Trial-management roles that do not meet the ICMJE authorship bar are recorded in the Acknowledgements with the trial registration number, sponsor, and funder reference.
