The BORAKA Verified Competence Standard for Clinical Research
A published, citable standard for how competence evidence is described, assessed, verified, and shared across clinical research.
- Author
- Rudolf Malle
- Publisher
- YANA Careers, LLC
- Published
- 02-Sep-2026, on Zenodo
- License
- CC BY 4.0
What the standard is for
The standard defines how evidence of job-relevant performance is described, assessed, reviewed, verified, and shared across clinical research. It is written to work the same way in biotech, pharma, academic, site, CRO, sponsor, and service-provider environments, so a piece of evidence means the same thing wherever it travels.
It does that by naming the competencies, the levels of performance, the types of evidence that count, and how far each piece of evidence has actually been taken. Two people can then look at the same record and agree on what it shows.
What the standard establishes
10
Operational domains
The areas of work competence is described against.
20
Canonical competencies
Named competencies shared across roles.
12
Registered role families
Roles the standard covers or reserves for development.
3
Specified role profiles
CRC, CRA and CTA, specified for public review.
4
Behavioral performance levels
How performance is described at each level.
5
Evidence Assurance Levels
How far a piece of evidence has been taken.
6
Evidence types
The forms evidence can legitimately take.
A claim and a verified performance are not the same thing
Five Evidence Assurance Levels, each one a step further than the last. The ladder is the heart of the standard: it says exactly how far a piece of evidence has been taken, and stops the word evidence from meaning everything and nothing.
- EAL 1
Reported exposure or claims
Someone states they have done the work. Nothing has been shown or checked.
- EAL 2
Demonstrated knowledge
The person shows they know what the work requires, under defined conditions.
- EAL 3
Demonstrated performance
The person produces the work itself against a defined task and criteria.
- EAL 4
Verified performance
A qualified reviewer assesses that work against the published criteria and records the result.
- EAL 5
Sustained verified practice
Verified performance repeated over time, in real practice, not a single occasion.
Read from the bottom up: reported exposure at the foot of the ladder, sustained verified practice at the top.
Three profiles specified, nine more registered
Version 1.0.0 specifies three role profiles in full for public review. The remaining role families are registered in the standard and reserved for development, so their names and scope are fixed before the detail is written.
CRC · Clinical Research Coordinator
CRA · Clinical Research Associate
CTA · Clinical Trial Assistant
- Investigator
- Clinical research nurse
- Clinical data management
- Clinical project and trial management
- Regulatory affairs and study start-up
- Pharmacovigilance and drug safety
- TMF and essential records
- Clinical quality and GCP audit
- Clinical scientist and medical monitor
Read the standard in full
Every file is deposited on Zenodo under the DOI, so what you download is the version of record.
The standard (PDF)
BORAKA-VCS-CR-001 version 1.0.0, the full specification.
Adoption guide (PDF)
How an employer, educator or assessor puts the standard to work.
Machine-readable JSON
Domains, competencies, levels and role profiles as structured data.
The full record
Every deposited file, the version history and the citation on Zenodo.
Citing the standard
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
What version 1.0.0 claims, and what it does not
A public review release
Version 1.0.0 is a public review release. It does not claim accreditation, regulatory approval, or universal employer recognition. It is a published specification, open for scrutiny, and it will change as that scrutiny comes in.
Review and comment
Practitioners, employers, and educators are invited to review and comment. The deposited record is the place to do it.
What the standard builds on
The standard is written to sit alongside existing frameworks rather than replace them.
- ICH E6(R3) Good Clinical Practice
- JTF/MRCT Core Competency Framework for Clinical Research Professionals
- 21 CFR (US Food and Drug Administration regulations)
- W3C Verifiable Credentials 2.0
- Open Badges 3.0
See the standard in practice
The free Role Readiness Scan uses the same competency structure the standard describes, so you can see how your own record maps onto it.