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.
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
