Working group Track D
Clinical research and clinical trials
The Clinical research and clinical trials working group defines the vocabulary that carries a trial from protocol through case report form to regulatory submission — IND/IDE filings, case report form (CRF) and eCRF design, electronic data capture (EDC) field definitions, CDISC-aligned datasets, and the HIPAA research-disclosure rules governing protected health information in a study record. It works with CDISC, ICH's E6(R3) Good Clinical Practice guideline, the FDA, and SCDM's Good Clinical Data Management Practice guidance to harmonise terminology across sponsors, sites, CROs and IRBs, so a data point captured on a CRF means the same thing from first-patient-in to database lock.
Charter and scope
What this working group covers
The Clinical research and clinical trials working group defines the vocabulary that carries a trial from protocol through case report form to regulatory submission — IND/IDE filings, case report form (CRF) and eCRF design, electronic data capture (EDC) field definitions, CDISC-aligned datasets, and the HIPAA research-disclosure rules governing protected health information in a study record. It works with CDISC, ICH's E6(R3) Good Clinical Practice guideline, the FDA, and SCDM's Good Clinical Data Management Practice guidance to harmonise terminology across sponsors, sites, CROs and IRBs, so a data point captured on a CRF means the same thing from first-patient-in to database lock.
- Case report form (CRF/eCRF) design and field-level data-element definitions
- Electronic data capture (EDC) system terminology and CRF-to-database mapping
- Clinical trial protocol structure and protocol-amendment vocabulary
- CDISC standards alignment (CDASH, SDTM, ADaM) for submission-ready datasets
- IND/IDE filing vocabulary and FDA-facing regulatory terminology
- HIPAA research-disclosure rules: minimum necessary standard, accounting of disclosures, authorization versus waiver
- ICH E6(R3) GCP roles, responsibilities and data-quality vocabulary across sponsors, sites and CROs
Composition
Current composition
Chair
Applications under review
Candidates are being assessed for the 2026 forming round. Two-year term, renewable once.
Submit your candidacy →Co-chair
Accepting candidates
Optional second chair, prioritised for regional or sector balance.
Submit your candidacy →Community seats
Accepting candidates for 12 seats
Seats are allocated against a published rubric covering domain expertise, institutional diversity, regional balance, and an explicit slot for early-career researchers.
Apply for a community seat →Deliverables
Planned and delivered deliverables
- CRF/eCRF field-naming convention aligned with CDISC CDASH
- Cross-walk: CRF field to CDASH variable to SDTM domain
- HIPAA research-disclosure vocabulary (minimum necessary, accounting of disclosures, authorization vs. waiver)
- IND/IDE filing terminology glossary for sponsors and CROs
- Implementer guidance for EDC field configuration and CRF design review
Recent activity
Working-group cadence and milestones
Illustrative working-group cadence for the 2026 forming round. Substantive deliverables and meeting minutes will be linked here as the group convenes.
2026-05-15 · Milestone
Working group forming — call for chair candidates
Open call for chair and co-chair of the Clinical research and clinical trials working group. Candidates are under review.
2026-04-22 · Release
Domain scope confirmed for v2026.2
Scope of the Clinical research and clinical trials domain confirmed against the v2026.2 dictionary release plan.
2026-03-10 · Added
Forming round announced
CASRAI announced the 2026 forming round for all 24 working groups, with seat allocations and review rubric published.
Open consultations
Currently in public comment
Currently none open. Subscribe via /get-involved/comment for future calls.
External bodies
Standards and organisations we work with
Going deeper on CASRAI
Related CASRAI guidance
Adjacent working groups
Related working groups
How to join
Apply to a seat on this working group
This working group is receiving candidates for the 2026 forming round. The application is short — name, institution, ORCID iD (optional), the seat you are applying for, and a paragraph on why this domain. Decisions are returned within four weeks of the close of the open-call window.
FAQ
Frequently asked
- What is eCRF in clinical trials?
An eCRF, or electronic case report form, is the electronic version of the paper case report form (CRF) used to capture participant data during a clinical trial through an electronic data capture (EDC) system. Sites enter protocol-specified data directly into the eCRF, which is then mapped to CDISC standards such as CDASH and SDTM for regulatory submission. eCRFs have largely replaced paper CRFs in modern trials because they support real-time data validation, audit trails and remote monitoring.
- What does CDISC stand for?
CDISC stands for the Clinical Data Interchange Standards Consortium, the nonprofit standards body that defines how clinical trial data — including case report form fields — is structured, named and submitted to regulators such as the FDA. Its standards include CDASH for data collection, SDTM for submission datasets and ADaM for analysis datasets. CDISC standards have been required for FDA study data submissions since December 2016.
- When does the minimum necessary standard apply to a disclosure?
The HIPAA minimum necessary standard applies whenever a covered entity uses, discloses, or requests protected health information, requiring that only the amount reasonably needed to accomplish the purpose be shared. It does not apply to disclosures for treatment, to the individual who is the subject of the information, or to uses made under a valid research authorization or an IRB/Privacy Board waiver. In clinical research, sponsors and sites document IRB or Privacy Board waivers to show that PHI accessed for a study meets this minimum-necessary requirement.
- What does this working group do?
The Clinical research and clinical trials working group is the community body that drafts, reviews and ratifies dictionary entries for the Clinical research and clinical trials domain. It maintains scope, cross-walks to adjacent standards and the cadence of public review. Its remit is summarised on this page; the canonical terms it stewards live at /dictionary/domain/clinical-research.
- Who can apply to join?
Working-group membership is open to qualified practitioners — researchers, research-office staff, librarians, publishers, repository managers, integrity officers, CRIS administrators, regulators and funders. Institutional membership is not required. The qualification test is competence and time, not affiliation. Apply via the working-group application form.
- What is the time commitment?
Cadence: Quarterly virtual sessions; two release windows per year (March and September).. Time commitment averages four hours per quarter for an active member, more for a chair. Asynchronous review happens between meetings via email. Chairs are recognised on the editorial masthead and serve a two-year term, renewable once.
- How are seats allocated?
Each working group has 12 community seats plus a chair and (optionally) a co-chair. Seats are filled by an open call reviewed against a published rubric: domain expertise, institutional diversity, regional balance, and an explicit slot for early-career researchers. Applications for the 2026 forming round are open and candidates are currently under review — see how to apply.
- Can my institution sponsor a seat?
Institutional sponsorship is welcome but is not a route to a guaranteed seat. Sponsors support meeting infrastructure, public-comment publication and contributor honoraria; they receive named acknowledgement on the working-group page and in release notes. Sponsorship enquiries go to [email protected]. Seat selection remains on merit.
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