Specialty · Clinical trials
Clinical trials
Trial publishing is governed by a dense alphabet: ICMJE for authorship, CRediT for contributions, CONSORT 2010 for RCT reporting, SPIRIT 2013 for protocols, ICH GCP E6(R3) for trial conduct, CDISC SDTM/ADaM for data, prospective registration before recruitment. This page maps which standard applies at which lifecycle stage — and where CASRAI vocabulary fits.
By lifecycle stage
Which standard applies when
Design
- SPIRIT 2013 (+ AI / Hi 2024 extensions)Protocol template — what to include in your trial protocol; mandatory by some funders + journals.
- ICH GCP E6(R3)Good Clinical Practice; 2025 revision; mandatory for any regulated trial.
- Funder DMP (NIH DMSP, Horizon Europe DMP)Data-management plan submitted at application.
Registration
- ClinicalTrials.gov / EU CTIS / ISRCTNProspective registration before first participant enrolled; ICMJE requirement.
- WHO ICTRP-recognised registryFor trials not eligible for the above; any WHO-network member.
Conduct
- ICH GCP E6(R3)GCP throughout; sponsor + investigator + monitor accountabilities.
- CDISC SDTM during data collectionSubmission Data Tabulation Model — the structured-data submission format expected by FDA.
Reporting
- CONSORT 2010 (RCTs)Reporting standard for randomised trials.
- CONSORT-AI 2020Extension for trials of AI / ML interventions.
- ICMJE Vancouver authorshipWho counts as an author.
- CRediT contributor statementWhat each author and acknowledged contributor did.
- Data-availability statementMost journals + ICMJE require one.
Post-publication
- Results posting on the registryFDAAA 801 (US): 12-month results posting on ClinicalTrials.gov.
- Underlying-data depositCDISC-conformant deposit on Vivli / YODA / Project Datasphere etc., per journal + funder.
- Retractions / correctionsCOPE-aligned process; updated registry record.
Going deeper
