BORAKA Verified Competence Standard for Clinical Research

The BORAKA Verified Competence Standard for Clinical Research defines how evidence of job-relevant performance is described, assessed, reviewed, verified, and shared across clinical research, biotechnology, pharmaceutical, academic, site, contract research organization, sponsor, and service-provider environments. The standard addresses a persistent evidence gap. Training completion can establish exposure. Knowledge tests can establish recall or reasoning under stated conditions. Self-report can describe confidence or experience. None, by itself, establishes that a person performed a defined responsibility to a defensible standard under known conditions. Version 1.0.0 establishes ten stable competency domains, twenty canonical competencies, twelve registered role families, three specified role profiles, four behavioral performance levels, five Evidence Assurance Levels, six evidence types, an Assessment Integrity Profile, critical safety and integrity rules, qualified human review, a minimum portable evidence record, and candidate-controlled disclosure through the BORAKA Passport. The standard is aligned at a high level with ICH E6(R3) Good Clinical Practice and is designed for crosswalk to the Joint Task Force for Clinical Trial Competency Framework. It complements existing competency taxonomies by specifying what must be known about the evidence behind a competence claim. This release is published for public and subject-matter-expert review. It is not an accreditation, professional license, regulatory approval, certification by an independent standards body, or claim of universal employer recognition.

Clinical research depends on people making sound decisions, producing reliable records, using controlled systems, protecting participants, and escalating risk within the boundaries of their roles. Yet many workforce records primarily document attendance, course completion, years of experience, self-reported confidence, or selected-response knowledge. BORAKA-VCS-CR-001 provides a common architecture for answering a more specific question: What observable, reviewable evidence supports the claim that a person performed a defined clinical research responsibility to a stated level under known conditions? The standard is designed to support:

1. realistic practice and simulation;

2. structured and verified performance assessment;

3. qualified human review and moderation;

4. evidence quality that can be compared without hiding assessment conditions;

5. portable, candidate-controlled evidence records;

6. employer evaluation of job-relevant evidence;

7. responsible use of artificial intelligence in assessment;

8. longitudinal workforce analysis using appropriately governed data;

9. transparent adoption by sites, CROs, sponsors, biotechnology companies, pharmaceutical

companies, academic institutions, training providers, and professional bodies.

Version 1.0.0 applies to evidence produced in simulated, structured, supervised, or governed live-practice environments. It covers people who conduct, coordinate, monitor, manage, support, analyze, or oversee clinical trials and related clinical-development activity. The standard defines:

1. stable competency domains and identifiers;

2. a role-family registry and role-profile maturity rules;

3. initial CRC, CRA, and CTA role profiles;

4. observable behavioral performance levels;

5. Evidence Assurance Levels that describe the strength of a competence claim;

6. evidence types and minimum sufficiency rules;

7. assessment modes and integrity profiles;

8. scoring, safety-critical, and integrity-critical decision rules;

9. qualified human review and AI-use boundaries;

10. portable evidence records, consent, privacy, and disclosure controls;

11. governance, versioning, validation, adoption, and conformance expectations.

This version does not:

1. automatically certify or authorize any individual to practice;

2. replace employer qualification, delegation, or supervision decisions;

3. replace applicable law, regulation, protocol, sponsor procedure, institutional policy, or

professional scope-of-practice rules;

4. state that all registered role families have released or validated assessment instruments;

5. disclose BORAKA casebooks, scenario content, item banks, detailed scoring rubrics, model

prompts, reviewer calibration materials, operational thresholds, or verification technology;

6. claim that every competency, crosswalk, task, rubric, or threshold has completed independent

psychometric or jurisdictional validation.

The terms MUST, MUST NOT, REQUIRED, SHOULD, SHOULD NOT, and MAY describe levels of conformance:

1. MUST or REQUIRED: necessary for conformance.

2. SHOULD: expected unless a documented, justified alternative achieves the same purpose.

3. MAY: optional.

Informative examples illustrate possible implementations. They do not create a requirement unless a normative statement says otherwise.

BORAKA-VCS-CR-001 does not replace a professional competency taxonomy, applicable regulation, or GCP guideline. It adds a verification and evidence layer.

The Joint Task Force for Clinical Trial Competency Framework defines broad domains and leveled knowledge, skills, and attitudes for clinical research. BORAKA-VCS-CR-001 uses a separate set of operational performance domains and provides a high-level crosswalk to the JTF structure. An adopter MUST NOT imply JTF or MRCT Center endorsement unless formal authorization exists. ICH E6(R3) defines principles and responsibilities for ethical, scientifically sound, and reliable trial conduct. BORAKA-VCS-CR-001 uses those principles and responsibilities as alignment anchors. It does not create a new interpretation of GCP or substitute for local requirements.

5.1 Performance before verified claims

A verified competence claim MUST be tied to observable evidence. Course attendance, self-report, a resume statement, years of experience, or selected-response knowledge alone MUST NOT create verified performance evidence.

5.2 Participant protection and reliable results

Assessment design MUST prioritize the rights, safety, and well-being of trial participants and the reliability of clinical trial results. A high composite score MUST NOT override a safety-critical or integrity-critical failure.

5.3 Practice, assessment, and verification are distinct

Practice MAY be repeatable, coached, untimed, and immediately scored. Structured assessment uses defined tasks and rubrics. Verified assessment adds declared identity, administration, evidence-preservation, review, and appeal controls. The three modes MUST be labeled accurately.

5.4 Evidence provenance

Every assessed result MUST identify the task, casebook, source artifacts, rubric, assessment mode, integrity profile, and review version that produced it.

5.5 Human accountability

Artificial intelligence MAY support role-play, transcription, structured observation, or preliminary analysis. An AI system MUST NOT independently issue, deny, revise, or invalidate BORAKA Verified status.

5.6 Candidate agency

Evidence MUST remain private by default. A person MUST control whether eligible evidence is shared, with whom, for how long, and whether access is revoked, subject to legal record-retention duties that are stated separately.

5.7 Accessibility and fairness

Assessment MUST measure job-relevant behavior. It MUST NOT score accent, voice quality, native-language fluency, disability-related characteristics, inferred emotion, or other characteristics unrelated to the competency.

5.8 Role boundaries

Assessment tasks MUST respect the authority of the role and jurisdiction. Appropriate recognition, inquiry, documentation, and escalation are valid evidence. A candidate MUST NOT be rewarded for making an unauthorized clinical, regulatory, or employment decision.

5.9 Stable identifiers

Each canonical competency has one meaning across role profiles. Role-specific behaviors extend that meaning without changing the underlying domain or competency definition.

5.10 Transparent maturity

Listing a role family does not mean that its tasks, rubrics, thresholds, or validation evidence are complete. Every role profile MUST disclose its release status.

The standard contains ten stable domains and twenty canonical competencies. Domain and competency identifiers are permanent within the major version.

D01. Participant Rights, Ethics, and Informed Consent

C01. Protect participant rights, safety, well-being, privacy, and confidentiality. Recognize and act

on circumstances that could compromise voluntary participation, safety, privacy, confidentiality, or equitable treatment.

C02. Conduct or evaluate the informed-consent process. Apply approved consent requirements,

confirm that consent precedes trial participation, identify consent defects, and escalate or remediate within role authority.

D02. Protocol Interpretation, Eligibility, and Study Planning

C03. Translate the protocol and schedule of activities into operational requirements. Identify

required procedures, time windows, dependencies, prohibited actions, decision points, and documentation expectations.

C04. Evaluate eligibility and protocol compliance. Apply inclusion and exclusion criteria, distinguish

facts from unresolved questions, avoid unauthorized medical decisions, and document the appropriate determination or escalation.

D03. Participant Safety and Safety Reporting

C05. Recognize and characterize safety information. Identify information requiring clinical evaluation,

obtain role-appropriate detail, distinguish urgency, and avoid delaying participant protection.

C06. Escalate, document, and follow safety-reporting requirements. Use the protocol, investigator

direction, sponsor process, and applicable requirements to support timely and traceable safety action.

D04. Study Conduct and Operational Execution

C07. Perform or oversee trial activities according to approved requirements. Coordinate visits,

procedures, vendors, participants, and staff while maintaining protocol and role boundaries.

C08. Manage operational exceptions and continuity. Recognize missed windows, unavailable

resources, scheduling conflicts, process failures, and other exceptions; document and escalate them appropriately.

D05. Source Documentation and Data Integrity

C09. Create or evaluate attributable and contemporaneous source records. Ensure that records

support what occurred, who performed it, when it occurred, and how the information can be verified.

C10. Maintain accurate, complete, consistent, and traceable data. Apply appropriate corrections,

preserve audit trails, reconcile discrepancies, and avoid obscuring original information.

D06. Clinical Systems and Data Workflow

C11. Perform or oversee role-appropriate work in clinical systems. Use EDC, CTMS, eTMF, safety,

randomization, document, or related systems within assigned access and procedural controls.

C12. Resolve data and document workflow issues. Investigate queries, missing data, inconsistent

records, reconciliation gaps, access problems, and workflow exceptions without creating unsupported information.

D07. Investigational Product, Device, and Specimen Accountability

C13. Maintain or evaluate custody and accountability. Apply requirements for receipt, storage,

access, dispensing or use, return, destruction, shipment, and reconciliation.

C14. Recognize and respond to accountability exceptions. Identify excursions, discrepancies,

missing records, broken custody, dosing or use concerns, and other exceptions; protect safety and evidence integrity.

D08. Regulatory and Essential Records

C15. Maintain or evaluate required approvals and essential records. Confirm that records are

current, complete, appropriately authorized, accessible, and consistent with trial conduct.

C16. Assess inspection and audit readiness. Identify material gaps, reconstruct the evidence trail,

distinguish missing documentation from missing activity, and support timely remediation.

D09. Quality, Risk, Monitoring, and Corrective Action

C17. Identify and prioritize quality risks and findings. Evaluate impact on participant protection, data

reliability, protocol compliance, and trial continuity.

C18. Investigate causes and develop proportionate corrective and preventive action. Separate

immediate correction from root cause, define ownership and due dates, and evaluate whether action was effective.

D10. Communication, Collaboration, and Professional Judgment

C19. Communicate effectively with relevant trial parties. Tailor accurate, respectful, role-appropriate

communication to participants, investigators, site staff, sponsors, CROs, vendors, and oversight bodies.

C20. Document and escalate decisions with professional judgment. Recognize the limit of personal

authority, communicate uncertainty, preserve the decision trail, and escalate before risk becomes harm.

7.1 Role-profile maturity

BORAKA uses four public maturity states. These states describe the maturity of a role profile, not the competence of an individual. Status Meaning Registered The role family has a stable identifier, boundary statement, and preliminary domain emphasis. It is not an assessment product. Specified The role purpose, boundary, and observable evidence expectations are published for public review. Pilot-ready Casebooks, tasks, rubrics, reviewer controls, and administration controls have passed internal quality review and are ready for governed pilots. Operational The profile is being administered under a declared integrity profile, with validation evidence and limitations reported separately. No profile may be described as validated solely because it is listed, specified, or available for use.

7.2 Role-family registry

Version 1.0.0 registers twelve role families. Three profiles are specified in this release. Nine are registered extensions for structured development and public review. Code Role family Primary evidence emphasis Version 1.0.0 status RP-CRC Clinical Research Coordinator Participant-facing conduct, source, EDC, visit execution, safety escalation Specified RP-CRA Clinical Research Associate or Monitor Oversight, source and system review, risk, findings, follow-up Specified RP-CTA Clinical Trial Assistant or Clinical Operations Associate Trial administration, CTMS, essential records, action tracking, controlled communication Specified RP-PI Principal Investigator or Sub- Investigator Medical oversight, delegation, participant safety, protocol decisions Registered RP-CRN Clinical Research Nurse Participant care interface, procedures, safety, consent support, source evidence Registered RP-CDM Clinical Data Management Professional Data lifecycle, edit checks, query strategy, reconciliation, database quality Registered RP-CPM Clinical Project Manager or Clinical Trial Manager Cross-functional delivery, risk, vendors, timelines, escalation, oversight Registered RP-REG Regulatory Affairs or Study Start-Up Professional Submissions, approvals, essential records, country and site activation Registered RP-PV Pharmacovigilance or Drug Safety Professional Case intake, assessment support, reporting workflow, reconciliation, signals Registered RP-TMF Trial Master File or Essential Records Professional Filing quality, completeness, metadata, inspection readiness, remediation Registered

Code Role family Primary evidence emphasis Version 1.0.0 status RP-QA Clinical Quality Assurance Professional or GCP Auditor Audit evidence, systemic risk, root cause, CAPA, effectiveness checks Registered RP- CSMM Clinical Scientist or Medical Monitor Protocol and medical review, safety interpretation, benefit-risk, escalation Registered The role registry is intentionally broader than a course catalog. It covers site, CRO, sponsor, biotechnology, pharmaceutical, academic, and service-provider work while keeping assessment claims tied to released profiles.

7.3 Clinical Research Coordinator profile

The CRC profile emphasizes site-level execution, participant interaction, source documentation, clinical-system workflow, visit coordination, and timely investigator escalation. Observable CRC evidence SHOULD include a representative combination of:

1. screening and eligibility review;

2. informed-consent process review or role-play;

3. source-note creation or correction;

4. EDC entry and query resolution;

5. visit-window planning;

6. safety-information intake and escalation;

7. deviation documentation;

8. investigational-product or specimen reconciliation;

9. regulatory-file maintenance;

10. participant, investigator, and sponsor communication.

Role-specific identifiers use the format VCSCR-CRC-C01 through VCSCR-CRC-C20.

7.4 Clinical Research Associate profile

The CRA profile emphasizes oversight, monitoring judgment, verification of site evidence, issue prioritization, risk-based follow-up, documentation of findings, and sponsor or CRO escalation. Observable CRA evidence SHOULD include a representative combination of:

1. review of consent and eligibility evidence;

2. source and EDC comparison;

3. monitoring of safety-reporting evidence;

4. evaluation of protocol deviations;

5. review of investigational-product accountability;

6. essential-record and delegation review;

7. risk identification and monitoring prioritization;

8. query and action-item management;

9. monitoring finding and visit-report production;

10. professional discussion with site staff and investigator escalation.

Role-specific identifiers use the format VCSCR-CRA-C01 through VCSCR-CRA-C20.

7.5 Clinical Trial Assistant profile

The CTA profile emphasizes controlled trial administration, document and system workflow, inspection-ready records, action tracking, and accurate cross-functional communication without exceeding role authority. Observable CTA evidence SHOULD include a representative combination of:

1. CTMS study, country, site, milestone, and contact maintenance;

2. collection and quality review of essential documents;

3. eTMF filing, metadata review, and reconciliation;

4. tracking of approvals, contracts, training, and site activation dependencies;

5. preparation of meeting records and action logs;

6. identification and escalation of missing, inconsistent, or expired documents;

7. controlled distribution of study communications and materials;

8. support for monitoring-visit and inspection-readiness logistics;

9. vendor, site, and internal follow-up within documented authority;

10. preservation of an accurate, attributable, and timely administrative trail.

Role-specific identifiers use the format VCSCR-CTA-C01 through VCSCR-CTA-C20.

7.6 Registered extensions

Registered role families MUST pass the role-profile release gate in Section 18 before they are described as specified, pilot-ready, or operational. BORAKA MAY publish compatible role modules as minor versions without changing the meaning of the core domains or assurance levels.

BORAKA separates three questions that are often collapsed into one score:

1. Performance level: how well did the person perform?

2. Evidence Assurance Level: how strong is the evidence behind the claim?

3. Evidence status: what is the current lifecycle state of the record?

A performance level MUST NOT be interpreted without its Evidence Assurance Level and assessment conditions.

8.1 Behavioral performance levels

The BORAKA rubric contains three affirmative performance levels. P0 records insufficient or unsafe evidence and is not an affirmative level. Code Level Observable standard P0 Not demonstrated Evidence is missing, materially incorrect, unsafe, unsupported, or insufficient for a defensible decision. P1 Guided application The person recognizes core requirements and can perform defined work with structured prompts, supervision, or correction.

Code Level Observable standard P2 Independent performance The person performs routine role-appropriate work accurately, documents decisions, identifies exceptions, and escalates appropriately without material prompting. P3 Adaptive performance The person integrates multiple evidence sources, manages ambiguity or competing risks, anticipates consequences, and produces a defensible result under realistic constraints. Performance levels describe observed behavior in a specified context. They MUST NOT be converted directly into years of experience, seniority, salary level, professional authorization, or independent practice rights.

8.2 Evidence Assurance Levels

Evidence Assurance Levels describe the strength of the inference that may be drawn from a competence record. They are not course grades and are not automatically cumulative. Code Level Minimum evidence basis Inference supported EAL0 Reported exposure or claim Completion record, attendance, resume claim, self-report, or unverified attestation The person reports experience, confidence, or exposure. No demonstrated-performance inference. EAL1 Knowledge demonstrated Scored knowledge or reasoning task under declared conditions The person demonstrated knowledge or reasoning in the assessed content. Limited inference about job performance. EAL2 Performance demonstrated Work sample, simulation, system task, or structured observation scored against a versioned rubric, with incomplete verification controls The person demonstrated performance in the stated task and conditions. Verification remains incomplete. EAL3 Performance verified Authenticated linkage, standardized task, versioned sources and rubric, preserved evidence, qualified human final decision, integrity profile, and appeal path The person performed the defined responsibility to the stated level under controlled, reviewable conditions. EAL4 Sustained verified practice EAL3 plus governed, longitudinal evidence from repeated or live practice, with authorized attestation and continuing validity controls The person has repeated the verified behavior over time in the stated practice context. Self-report is classified within EAL0 rather than placed above knowledge evidence. Workplace attestation without a prior EAL3 foundation remains EAL0 unless the attestation itself includes reviewable performance evidence and satisfies a higher level. An EAL4 record MUST NOT be interpreted as a professional license, regulatory authorization, or guarantee of future performance.

8.3 Evidence types

The standard recognizes six evidence types:

1. Knowledge evidence: explanation, recognition, calculation, or selected response.

2. Decision evidence: a choice plus documented reasoning, authority boundary, and consequence.

3. Work-product evidence: a completed source note, query, report, action log, reconciliation, plan,

or comparable artifact.

4. System-interaction evidence: role-appropriate activity completed in an EDC, CTMS, eTMF,

safety, randomization, document, analytics, or comparable system.

5. Communication evidence: written or spoken interaction captured as a transcript, structured

observation, or reviewed communication product.

6. Longitudinal evidence: repeated performance observed over time in an appropriately governed

environment.

8.4 Evidence sufficiency

EAL3 or EAL4 performance evidence MUST NOT rely only on knowledge evidence. For each safety-critical domain included in a verified profile, the evidence set MUST contain:

1. at least one decision, work-product, system-interaction, or communication artifact;

2. observable reasoning or an auditable action trail;

3. versioned source artifacts and rubric;

4. qualified human review;

5. a recorded critical-rule outcome;

6. the applicable Assessment Integrity Profile.

8.5 Evidence chain

The minimum traceability chain is: Competency requirement -> role profile -> casebook -> task -> source artifacts -> candidate action -> observable evidence -> rubric judgment -> human review -> evidence record -> candidate-controlled disclosure

8.6 Evidence status

Status Meaning Practice Educational result from a repeatable or coached experience Assessed Evidence produced against a rubric without the complete EAL3 verification controls Human-reviewed A qualified reviewer finalized the rubric judgment BORAKA Verified Required EAL3 or EAL4 controls, profile rules, evidence, critical rules, and human review were satisfied Expired Evidence passed its stated validity or reassessment date Invalidated Evidence was withdrawn because of a material administration, integrity, legal, or correction issue Human-reviewed does not automatically mean BORAKA Verified. BORAKA Verified is an issuer status reserved for a conformant BORAKA-authorized profile.

9.1 Practice

Practice is designed for learning. It MAY be repeatable, untimed, coached, or immediately scored. Practice results MUST be labeled as practice and MUST NOT create BORAKA Verified evidence.

9.2 Structured assessment

Structured assessment uses defined tasks, source materials, and rubrics but may not include all identity, timing, attempt, evidence-preservation, or review controls required for verification. Results MUST state which controls were and were not present. A structured performance assessment normally produces no more than EAL2 evidence.

9.3 Verified assessment

Verified assessment is designed to produce EAL3 or EAL4 evidence. It MUST include:

1. authenticated candidate linkage;

2. a declared identity-assurance level;

3. versioned casebook, source artifacts, tasks, and rubric;

4. standardized and job-relevant conditions;

5. server-authoritative timing when timing is part of the competency construct;

6. a defined attempt and waiting-period policy;

7. declared response-control and accommodation policies;

8. preserved evidence and material incident records;

9. qualified human final review;

10. conflict-of-interest and moderation controls;

11. an appeal, correction, and invalidation process;

12. a profile-specific expiration or reassessment rule.

The word proctored MUST NOT be used unless a real proctoring method is present and accurately described.

An implementation produces EAL3 evidence only when it meets the requirements in this section.

10.1 Conditions

1. Standardized. Candidates assessed against the same target MUST encounter materially

equivalent conditions, source information, constraints, and decision opportunities.

2. Realistic. Conditions SHOULD reproduce the documents, systems, time pressure, ambiguity,

and interpersonal dynamics relevant to the job responsibility.

3. Performance-based. The candidate MUST do the task rather than only describe it. A verbal

performance is appropriate when communication itself is the target.

4. Role-bounded. The task MUST not reward activity outside the authority of the assessed role.

5. Versioned. The task, source materials, rubric, administration rules, and critical rules MUST carry

stable versions.

10.2 Candidate and identity controls

The protocol MUST state how the candidate is linked to the result. Identity assurance MAY be account-linked, document-confirmed, live-confirmed, employer-confirmed, or another accurately described method. The method MUST be proportionate to the intended use and privacy risk.

10.3 Reviewer qualification and decision independence

A reviewer MUST:

1. have documented role-relevant expertise or demonstrated equivalent competence;

2. complete task-specific rubric training and calibration;

3. rate the preserved evidence against the current rubric;

4. disclose and manage material conflicts of interest;

5. avoid scoring based on personal familiarity, reputation, protected characteristics, or information

outside the evidence record. Decision independence means that the final competence judgment is protected from an unchecked interest in the outcome. A reviewer MAY be employed or contracted by the issuer. If the reviewer trained the candidate, directly manages the candidate, or has another material conflict, a second qualified reviewer or moderator MUST approve the final decision and the control MUST be recorded. An absolute absence of financial relationship is not required because it would prevent legitimate assessment organizations from employing qualified reviewers. Disclosure, role separation, calibration, sampling, and moderation are the required safeguards.

10.4 Instrument

The assessment instrument MUST include:

1. observable criteria linked to a canonical competency and role profile;

2. behavioral anchors for P0 through P3 where the full scale is used;

3. safety-critical and integrity-critical indicators identified before administration;

4. a documented decision rule for verified or not verified;

5. a stated evidence sufficiency rule;

6. an accommodation rule that protects the intended construct;

7. a defined process for rubric changes and retirement.

The public standard describes the rubric structure. Detailed prompts, answer keys, scenario logic, scoring weights, operational thresholds, and calibration examples MAY remain controlled implementation assets.

10.5 Process

1. The candidate receives the verification target, evidence level, general conditions, consent terms,

and applicable policies before the attempt.

2. Identity and system readiness are confirmed to the declared level.

3. Performance occurs under the versioned administration protocol.

4. Evidence and material incidents are preserved with integrity references.

5. A qualified reviewer rates the evidence against the applicable rubric.

6. Moderation or a second rating is applied when required by conflict, sampling, quality, or appeal

rules.

7. The result is issued, denied, corrected, or invalidated under the versioned decision rule.

8. The candidate receives structured feedback and an appeal or correction route.

9. Any portable record is issued under Section 14.

10.6 Reassessment and continuing validity

Every EAL3 or EAL4 profile MUST define a validity or reassessment rule based on the competency, regulatory change, technology change, time away from practice, and intended use. Version 1.0.0 does not impose one universal expiration period because the evidence for an appropriate interval differs by responsibility and risk. The record MUST disclose its issue date, review date, expiration or reassessment date when applicable, and the rule used. An EAL4 attestation MAY support continuing validity only within the limits of the profile and the evidence supplied.

Every structured or verified result MUST disclose an Assessment Integrity Profile containing: Field Required description Assessment mode Practice, structured assessment, or verified assessment Intended Evidence Assurance Level EAL0 through EAL4 Identity assurance None, account-linked, document-confirmed, live-confirmed, employer-confirmed, or another defined method Attempt policy Number of attempts, waiting period, and invalidation rules Timing Suggested, candidate-controlled, or server-authoritative Response controls Paste, navigation, external-resource, communication, and session rules Source controls Artifact versions, hashes, provenance, and rights status Observation methods Written, system, document activity, voice, video, live, or human observation Human review Reviewer qualification, decision-independence control, rubric version, and moderation status Accommodations Approved adjustments and whether the intended construct changed Incidents Material system, identity, evidence, or administration events affecting interpretation Controls are evidence about assessment conditions. They are not proof that misconduct or error was impossible.

12.1 Criterion scoring

Each scored criterion uses P0 through P3. A domain score MAY be normalized to 0 through 100: Domain score = 100 x sum(weight x criterion score / 3) / sum(weights) An overall Competency Score MAY aggregate required domain outcomes using a versioned role-profile weight set. The score MUST be treated as an interpretation aid, not as a replacement for task-level and critical-rule results.

12.2 Interpretation

A score or verified outcome MUST always be displayed with:

1. role profile and profile status;

2. competency and domain identifiers;

3. casebook, task, source-artifact, and rubric versions;

4. assessment mode and Evidence Assurance Level;

5. Assessment Integrity Profile;

6. evidence date and current status;

7. human-review and moderation status;

8. critical-rule outcome;

9. expiration or reassessment rule when applicable.

A score without those fields is not a portable verified claim under this standard.

12.3 Critical-rule logic

Each verified role profile MUST define safety-critical and integrity-critical rules. Examples include:

1. knowingly proceeding without valid informed consent;

2. enrolling or randomizing when required eligibility is unresolved;

3. failing to escalate urgent participant-safety information;

4. fabricating, concealing, or backdating source information;

5. obscuring a material audit trail;

6. sharing real participant information in an unauthorized environment;

7. directing activity outside role authority in a manner that creates participant or data risk.

A critical failure MUST prevent verified status for the affected assessment regardless of composite score. The candidate MUST receive a documented outcome and an applicable remediation or appeal path.

12.4 Calibration and proprietary boundary

Public formulas describe the evidence architecture. Operational weights, thresholds, item parameters, casebook difficulty estimates, reviewer calibration materials, and production decision rules MAY remain proprietary. Any production threshold MUST be versioned and supported by validation evidence appropriate to its intended use.

13.1 Human final decision

A qualified human reviewer MUST issue, deny, revise, or invalidate EAL3 or EAL4 evidence and BORAKA Verified status.

13.2 Permitted AI support

AI MAY:

1. operate a fictional role in a simulation;

2. transcribe an interaction with appropriate notice and consent;

3. identify candidate statements or actions for reviewer attention;

4. populate a structured preliminary observation record;

5. check required-field completeness;

6. support practice feedback;

7. assist a reviewer in locating evidence without replacing the reviewer's judgment.

AI MUST NOT:

1. independently issue, deny, revise, or invalidate verified status;

2. infer dishonesty, intent, emotion, disability, or protected characteristics;

3. score accent, voice quality, or language background unless a narrowly defined, job-relevant

language construct is explicitly being assessed;

4. introduce facts not authorized by the scenario;

5. coach or reveal answers during verified assessment;

6. silently change a final human judgment;

7. train on private candidate evidence without a separate lawful basis and clear notice.

13.3 Reviewer controls

Reviewer identity and internal notes SHOULD remain private unless law or an authorized quality process requires disclosure. The evidence record MUST retain reviewer authorization, decision timestamp, rubric version, conflict control, and moderation status. Reviewer agreement SHOULD be measured before a new task or evidence type becomes eligible for verified use.

A conformant evidence record MUST contain:

1. evidence identifier;

2. standard identifier and version;

3. holder identifier or privacy-preserving reference;

4. issuer legal name and issuer identifier;

5. role profile and profile status;

6. competency and domain identifiers;

7. behavioral performance outcome;

8. Evidence Assurance Level;

9. casebook, task, source-artifact, and rubric versions;

10. artifact hashes or equivalent immutable references;

11. evidence types;

12. assessment mode;

13. Assessment Integrity Profile;

14. criterion and domain outcomes as applicable;

15. critical-rule outcomes;

16. human-review, conflict-control, and moderation status;

17. issue, review, expiration, reassessment, and invalidation dates as applicable;

18. evidence status;

19. disclosure and consent status;

20. verification endpoint.

Raw written answers, audio, video, transcripts, reviewer notes, employer campaign data, and unrelated personal information MUST NOT appear in a public Passport view. The record format SHOULD be technology-neutral. Implementers MAY express it using W3C Verifiable Credentials, Open Badges, or another portable format when they accurately disclose the specification and version used.

The BORAKA Passport is the reference portable-evidence implementation for eligible BORAKA records. Passport evidence MUST be:

1. private by default;

2. linked to the originating evidence record;

3. specific about role, competency, task, version, mode, assurance level, and review;

4. shared only through an explicit candidate action or separately authorized legal process;

5. scoped to an evidence allowlist;

6. time-limited unless a different duration is explicitly chosen and permitted;

7. revocable when shared;

8. rechecked for current validity on every view;

9. protected from public search indexing by default;

10. accompanied by privacy-preserving access records.

Employer discovery is separate from evidence sharing. A person MUST explicitly opt in before BORAKA Talent makes an eligible profile discoverable.

A conformant assessment program MUST:

1. provide reasonable accessibility accommodations;

2. record whether an accommodation changed the intended construct;

3. offer a text alternative where voice is not essential to the competency;

4. obtain explicit notice and, where required, consent for microphone, camera, recording,

transcription, and retention;

5. instruct candidates not to disclose real patient or confidential study information;

6. minimize retention of raw audio, video, and transcripts;

7. separate required assessment terms from optional marketing, analytics, research, and employer-

discovery consent;

8. provide a way to correct identity or record errors;

9. prevent small-group workforce reporting from exposing identifiable performance;

10. review performance differences and adverse impact when sample size and lawful use support

valid analysis.

Version 1.0.0 uses verified primary-source anchors at the domain level. It does not claim completed independent attestation of every competency-to-clause or competency-to-framework mapping. BORAKA domain Primary JTF domain alignment Primary ICH E6(R3) anchors D01 Participant Rights, Ethics, and Informed Consent Ethical and Participant Safety Considerations; Communication and Teamwork Principles 1 through 3; Annex 1 sections 1, 2.4, and 2.8 D02 Protocol Interpretation, Eligibility, and Study Planning Scientific Concepts and Research Design; Clinical Study Operations Annex 1 sections 2.5 and 2.12; Appendix B sections B.4, B.5, and B.7 D03 Participant Safety and Safety Reporting Ethical and Participant Safety Considerations; Investigational Products Development and Regulation Principle 1; Annex 1 sections 2.7 and 3.13 D04 Study Conduct and Operational Execution Clinical Study Operations; Study and Site Management Annex 1 sections 2.3, 2.5, 2.12, and 2.13 D05 Source Documentation and Data Integrity Clinical Study Operations; Data Management and Informatics Annex 1 sections 2.12 and 3.16; section 4.2 D06 Clinical Systems and Data Workflow Data Management and Informatics; Scientific Concepts and Research Design Annex 1 sections 4.2 and 4.3 D07 Investigational Product, Device, and Specimen Accountability Investigational Products Development and Regulation; Clinical Study Operations Annex 1 sections 2.10 and 3.15 D08 Regulatory and Essential Records Investigational Products Development and Regulation; Study and Site Management Annex 1 sections 1 and 2.4; Appendix C D09 Quality, Risk, Monitoring, and Corrective Action Clinical Study Operations; Study and Site Management; Leadership and Professionalism Annex 1 sections 3.9 through 3.12, including section 3.11.4 D10 Communication, Collaboration, and Professional Judgment Communication and Teamwork; Leadership and Professionalism Principles and role-appropriate investigator, sponsor, and IRB or IEC communication requirements

United States implementations SHOULD also identify applicable provisions of 21 CFR Parts 11, 50, 56, and 312 and current FDA guidance. Non-US implementations MUST identify their local requirements rather than treating the United States crosswalk as universal.

18.1 Version scheme

BORAKA-VCS-CR-001 uses semantic versioning:

1. Major: incompatible change to meaning, identifiers, assurance levels, or evidence architecture.

2. Minor: added competencies, role profiles, evidence types, or compatible governance

requirements.

3. Patch: correction or clarification that does not change competency meaning or score

interpretation.

18.2 Change control

Every public release MUST include:

1. the complete standard;

2. a machine-readable specification;

3. a change log;

4. an adoption guide;

5. a license notice;

6. a permanent citation or DOI;

7. the status of role profiles, crosswalk review, and validation evidence.

Published files MUST NOT be silently replaced when the content changes. A new version MUST be created and linked to prior versions.

18.3 Role-profile release gate

A role profile MAY enter specified status as an authored public-review draft. Before a specified profile becomes pilot-ready, BORAKA SHOULD obtain documented review from at least two role-relevant subject-matter experts and one assessment reviewer. A pilot-ready profile MUST have:

1. a role-boundary statement;

2. competency applicability and observable behaviors;

3. an evidence plan covering job-relevant evidence types;

4. versioned tasks, source materials, rubrics, and critical rules;

5. administration, accessibility, privacy, and incident controls;

6. reviewer training and calibration materials;

7. a pilot analysis plan.

Before a profile becomes operational, BORAKA MUST publish a validation summary and known limitations appropriate to the intended use.

18.4 Review structure

The governance process SHOULD include:

1. clinical operations subject-matter experts;

2. role-specific reviewers for each released profile;

3. an assessment or psychometrics specialist;

4. employer representatives from sites, CROs, sponsors, biotechnology, or pharmaceutical

organizations;

5. candidate or learner representation;

6. accessibility, privacy, security, and legal review.

18.5 Validation roadmap

BORAKA SHOULD publish separate evidence for:

1. content-validity review;

2. task and rubric review;

3. reviewer calibration and agreement;

4. score reliability and decision consistency;

5. fairness and accessibility analysis;

6. relationship between evidence and employer decisions or onboarding outcomes;

7. reassessment and expiration policy;

8. observed limitations, incidents, and corrective changes.

18.6 Public comment

Version 1.0.0 opens a 90-day public comment period from the date of publication. Comments from professionals, candidates, sites, CROs, sponsors, biotechnology and pharmaceutical organizations, academic institutions, training providers, assessors, professional bodies, and accessibility or privacy specialists are invited.

An organization MAY cite or adopt BORAKA-VCS-CR-001 when it identifies:

1. the standard version used;

2. the domains, competencies, and role profiles adopted;

3. the status of each role profile;

4. the assessment mode and intended Evidence Assurance Level;

5. the evidence and integrity controls present;

6. local requirements and modifications;

7. the issuer and verification endpoint for any record.

Three conformance descriptions are permitted:

1. BORAKA-VCS-CR aligned: uses the public domains, competencies, assurance terminology, or

role registry with attribution.

2. BORAKA-VCS-CR evidence-conformant: produces the minimum evidence record and declares

assessment conditions, but does not imply BORAKA authorization.

3. BORAKA Verified: reserved for evidence issued through a BORAKA-authorized profile that

satisfies the applicable EAL3 or EAL4, critical-rule, and human-review requirements. Use of this open standard does not imply BORAKA, YANA Careers, JTF, MRCT Center, ICH, regulator, employer, or professional-body endorsement.

The text of BORAKA-VCS-CR-001, its public competency taxonomy, role registry, Evidence Assurance Levels, and public evidence schema are licensed under Creative Commons Attribution 4.0 International. The following are excluded from that license unless YANA Careers, LLC provides a separate written license:

1. casebooks and scenario content;

2. item banks and answer keys;

3. detailed scoring rubrics;

4. operational weights, thresholds, and decision parameters;

5. item parameters, difficulty estimates, and calibrations;

6. reviewer training and moderation materials;

7. model prompts and simulation-control logic;

8. verification technology and security controls;

9. learner, employer, and assessment data;

10. BORAKA, Competency Labs, CompetencyScore, BORAKA Passport, BORAKA Verified, and

related names, marks, logos, and brand assets. The CC BY 4.0 license allows the public standard to be quoted, translated, mapped, and adapted with attribution. It does not authorize another organization to represent itself as BORAKA or to issue BORAKA Verified records.

The verification and performance-evidence approach reflected in this standard was developed by Rudolf Malle through work beginning in 2023 across GCP Fastrack, YANA Careers, VeraClin, and Competency Labs, with dated internal artifacts retained by YANA Careers, LLC. Before public release, two unpublished working drafts, a Verified Competence Standard draft and a Clinical Research Performance Evidence Standard draft, were consolidated into this single standard. Neither working draft is a separate public standard. BORAKA-VCS-CR-001 is the sole canonical submission. This provenance statement documents BORAKA's development history. It does not assert that other organizations could not have independently developed related ideas, taxonomies, or assessment methods.

This release is an authored public standard under active review. It has not yet completed independent attestation, universal jurisdictional mapping, large-sample psychometric validation, or operational validation across all twelve registered role families. Only CRC, CRA, and CTA role profiles are specified in Version 1.0.0, and specified does not mean validated or operational. BORAKA will report validation evidence and employer-utility evidence separately as it becomes available. Users MUST evaluate local law, protocol, sponsor procedure, institutional policy, role authority, intended use, and available evidence before relying on a result.

1. International Council for Harmonisation. ICH Harmonised Guideline: Guideline for Good Clinical

Practice E6(R3), Final Consolidated Guideline. Adopted June 16, 2026. https://database.ich.org/sites/default/files/ICH%20E6(R3)_Step4_FinalConsolidatedGuideline_20 26_0616_.pdf

2. Joint Task Force for Clinical Trial Competency, MRCT Center. Core Competency Framework for

Clinical Research Professionals: Domains and Leveled Core Competencies. https://mrctcenter.org/clinical-trial-competency/framework/domains/

3. Electronic Code of Federal Regulations. Title 21, applicable clinical research provisions, including

Parts 11, 50, 56, and 312. https://www.ecfr.gov/current/title-21

4. United States Food and Drug Administration. Data Integrity and Data Quality in Application

Submissions. https://www.fda.gov/media/165536/download

5. World Wide Web Consortium. Verifiable Credentials Data Model v2.0. https://www.w3.org/TR/vc-

data-model-2.0/

6. 1EdTech Consortium. Open Badges Specification, Version 3.0.

https://www.1edtech.org/standards/open-badges

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

Public review should focus on:

1. whether the ten domains and twenty competencies reflect real work across the released profiles;

2. whether the Evidence Assurance Levels support defensible and understandable claims;

3. whether performance levels are observable and distinguishable;

4. whether role-profile maturity labels prevent overstatement;

5. whether safety-critical and integrity-critical rules are appropriate;

6. whether reviewer independence and conflict controls are practical and credible;

7. whether the evidence record is useful to employers and fair to candidates;

8. whether reference anchors and crosswalks are accurate;

9. whether accessibility, privacy, AI-use, and candidate-control requirements are sufficient;

10. which registered role families should be specified next.

Comments, proposed corrections, validation partnerships, and adoption inquiries should be routed through the official BORAKA standards page when released.

The following example is illustrative and does not represent a real person or issued credential. Field Example value Holder J. Doe, holder identifier BV-000000 Issuer YANA Careers, LLC, operating BORAKA Competency Labs Standard BORAKA-VCS-CR-001 v1.0.0 Profile RP-CRC, Specified Target D01-C02, informed-consent process Performance P2, Independent performance Assurance EAL3, Performance verified Method Standardized simulation with a fictional participant and versioned source documents Review Qualified human reviewer; calibration current; no material conflict; sampled moderation complete Critical rules All applicable critical indicators met Dates Assessed September 15, 2026; issued September 16, 2026; reassessment date stated in record Status BORAKA Verified Integrity Verification endpoint and immutable evidence references retained by issuer

Version Date Change 1.0.0 September 2, 2026 Initial public-review release. Consolidates the prepublication VCS-CR and CRPES working drafts; establishes ten domains, twenty competencies, five Evidence Assurance Levels, twelve registered role families, and specified CRC, CRA, and CTA profiles.