Why this discipline needs its own guide
Background
Clinical medicine research is highly regulated and peer-reviewed, requiring absolute transparency in attribution. The assignment of CRediT contributor roles must align seamlessly with international guidelines such as the ICMJE Vancouver criteria and study-specific reporting frameworks. These frameworks include CONSORT for randomized trials, CARE for clinical case reports, STROBE for observational studies, and PRISMA for systematic reviews and meta-analyses.
Integrating the 14 NISO CRediT roles within clinical trials and medical research prevents authorship disputes, ensures compliance with journal mandates, and clarifies the specialized roles of clinical trial coordinators, data monitors, biostatisticians, principal investigators, and patient-facing clinicians.
Key considerations
How to assign the roles
- Every co-author must meet the four ICMJE criteria for authorship. CRediT does not determine authorship eligibility, but details what each approved author contributed.
- Distinguish physical patient-facing clinical duties (Investigation) from administrative site oversight, trial logistics, or institutional coordination (Project Administration).
- Providing clinical laboratory space, patient referrals, or standard clinical facilities without active intellectual participation maps to Resources, and is not sufficient for co-authorship on its own.
- Designing clinical protocols and drafting institutional review board (IRB) ethical submissions belongs to Methodology, Conceptualization, and Project Administration.
- Conducting systematic literature searches and designing database queries for systematic reviews maps to Methodology and Data Curation.
- Performing medical chart reviews, collecting patient clinical data, and maintaining the trial registry maps to Data Curation and Investigation.
Reporting Guideline Integration
Clinical Reporting Standards to CRediT Crosswalk
Mapping CARE, CONSORT, STROBE, and PRISMA Reporting Elements to CRediT Roles
Clinical manuscripts are governed by rigorous reporting guidelines. This comprehensive crosswalk maps the critical elements of CARE (case reports), CONSORT (randomized trials), STROBE (observational studies), and PRISMA (systematic reviews) to their corresponding CRediT contributor roles.
| Checklist Item / Phase | Mapped CRediT Role(s) | Guidance & Practical Allocation |
|---|---|---|
| CARE: Clinical NarrativeSynthesizing patient demographics, medical history, physical exams, and clinical timelines. | InvestigationData CurationWriting – Original Draft | Extracting historical charts is Investigation. Structuring and anonymizing the data is Data Curation. Compiling the case narrative is Writing – Original Draft. |
| CARE: Diagnostic & Therapeutic ActionsFormulating diagnostic reasoning, administering pharmacological/surgical interventions. | MethodologyInvestigation | Establishing the diagnostic workup protocol is Methodology. Executing the procedures and treating the patient is Investigation. |
| CONSORT: Trial Randomization & DesignDesigning randomization sequences, allocation concealment, and study-arm blinding. | MethodologyFormal Analysis | Formulating the randomization and blinding scheme belongs under Methodology. Mathematically generating the random sequence maps to Formal Analysis. |
| CONSORT: Intervention ImplementationSourcing, preparing, and administering investigational medicinal products (IMPs) or placebo. | ResourcesInvestigation | Providing and compounding clinical materials maps to Resources. Physically administering the interventions to trial participants is Investigation. |
| CONSORT: Recruitment & FlowchartScreening participants, maintaining recruitment logs, and assembling the participant flow diagram. | InvestigationProject AdministrationVisualization | Patient screening is Investigation. Monitoring enrollment rates is Project Administration. Generating the CONSORT flowchart maps to Visualization. |
| STROBE: Observational Cohort SelectionDefining eligibility criteria, source populations, cohort selection, and follow-up methods. | MethodologyProject Administration | Designing epidemiological cohort parameters is Methodology. Managing the multi-site longitudinal tracking is Project Administration. |
| STROBE: Bias Control & ConfoundingAddressing potential sources of bias and executing statistical adjustments for confounding factors. | MethodologyFormal Analysis | Conceiving bias mitigation strategies belongs to Methodology. Running multivariate regression or propensity score matching is Formal Analysis. |
| PRISMA: Systematic Search StrategyFormulating comprehensive search strings and querying bibliographic databases (MEDLINE, Embase). | MethodologyData Curation | Designing the structured search queries is Methodology. Executing search strings, exporting citations, and removing duplicates is Data Curation. |
| PRISMA: Study Screening & EligibilityDual-blind screening of titles, abstracts, and full texts against inclusion/exclusion criteria. | InvestigationValidation | Independently screening citations against eligibility criteria is Investigation. Resolving screen conflicts and auditing inclusions is Validation. |
| PRISMA: Risk of Bias AssessmentAssessing study-level risk of bias and methodological quality (Cochrane RoB 2, Newcastle-Ottawa scale). | ValidationFormal Analysis | Performing formal quality risk evaluations is Validation. Synthesizing risk profiles into meta-analysis covariates maps to Formal Analysis. |
| PRISMA: Meta-Analytical PoolingStatistical pooling of clinical outcomes, heterogeneity assessment, and funnel plot generation. | Formal AnalysisSoftwareVisualization | Running statistical pooling, effect-size modeling, and sensitivity tests is Formal Analysis. Writing custom R/Stata scripts is Software. Drawing funnel or forest plots is Visualization. |
Worked example
A representative CRediT statement
Author Contributions (CRediT) Dr. J. Carter: Conceptualization, Methodology (protocol design), Writing – original draft, Supervision. Dr. A. Kovac: Investigation (patient-facing clinical care), Data curation. Prof. E. Vance: Funding acquisition, Supervision, Writing – review & editing. M. Ross: Project administration (trial site coordination), Data curation (database lock). T. Miller: Formal analysis (biostatistical modeling), Visualization. Dr. H. Choi: Validation (trial data monitoring), Writing – review & editing.
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
Can a clinician who only recruited patient cohorts qualify for CRediT Investigation?
Yes, patient recruitment, physical examinations, and delivering clinical interventions are recorded under Investigation. However, under ICMJE guidelines, they must also contribute intellectually (e.g., revising the manuscript and approving the final version) to be listed as an author; otherwise, they should be acknowledged under contributors.
How does CRediT map to the PRISMA systematic review guidelines?
Under PRISMA, defining the search strategy is Methodology. Running the search and screening abstracts is Data Curation and Investigation. Extracting data and checking quality is Validation, and running meta-analytical models is Formal Analysis.
What role is assigned to the clinical trial data monitor?
Independent trial data monitors who perform clinical data verification and audit compliance map directly to Validation and Project Administration.
