- Identifier
- TC-P-003
- Version
- 1.0
- Date
- Author
- Rudolf Malle, Kirabi Works, Inc.
The standard was published under the company's former name. Kirabi Works, Inc. is the same company.
Summary
The standard behind the Passport Office is published separately as BORAKA-VCS-CR-001 version 1.0.0, Public Review Release, 2 September 2026, DOI 10.5281/zenodo.22256856, CC BY 4.0. This page is the plain summary; the version of record is the DOI.
What it is for
Evidence of job-relevant performance in clinical research, described, assessed, reviewed, verified and shared, because training completion and knowledge tests alone do not show that someone performed a responsibility to a defensible standard.
Ten domains
- Participant Rights, Ethics, and Informed Consent
- Protocol Interpretation, Eligibility, and Study Planning
- Participant Safety and Safety Reporting
- Study Conduct and Operational Execution
- Source Documentation and Data Integrity
- Clinical Systems and Data Workflow
- Investigational Product, Device, and Specimen Accountability
- Regulatory and Essential Records
- Quality, Risk, Monitoring, and Corrective Action
- Communication, Collaboration, and Professional Judgment
Five Evidence Assurance Levels
- EAL0 Reported exposure or claim: the person reports experience or exposure; no inference of demonstrated performance.
- EAL1 Knowledge demonstrated: knowledge or reasoning shown under declared conditions; limited inference about job performance.
- EAL2 Performance demonstrated: performance shown in a scored task, with incomplete verification controls.
- EAL3 Performance verified: a defined responsibility performed to a stated level under controlled, reviewable conditions, with a qualified human making the final decision.
- EAL4 Sustained verified practice: EAL3 plus governed, longitudinal evidence from repeated or live practice.
Six evidence types
- Knowledge
- Decision
- Work-product
- System-interaction
- Communication
- Longitudinal
How Trial City functions map to the standard's role families
| Trial City function | Role family |
|---|---|
| CRA or monitor | Clinical Research Associate |
| Study coordinator or site staff | Clinical Research Coordinator |
| Clinical research nurse | Clinical Research Nurse |
| Investigator or physician | Principal Investigator |
| Project or trial manager | Clinical Trial Manager |
| Data management or biostatistics | Clinical Data Manager |
| Regulatory | Regulatory Affairs |
| Drug safety or pharmacovigilance | Pharmacovigilance |
| MSL or medical affairs | not yet mapped |
| Decentralized trials or home visits | not yet mapped |
| Quality or audit | Clinical Quality |
| Lab or sample logistics | not yet mapped |
| Vendor or technology | not yet mapped |
| New to research | not yet mapped |
| Other | not yet mapped |
Read the standard
Limitations
Quoted from the standard: it has not completed independent attestation, universal jurisdictional mapping or large-sample psychometric validation; only three role profiles (CRC, CRA, CTA) are specified; specified does not mean validated or operational.
It is not an accreditation, licence, regulatory approval or claim of universal employer recognition.
Changes
- October 14, 2026: Version 1.0 published.
Cite this
Malle, R. (2026). BORAKA Verified Competence Standard for Clinical Research (BORAKA-VCS-CR-001, version 1.0.0). YANA Careers, LLC. https://doi.org/10.5281/zenodo.22256856