Choose the role you are working toward, begin with realistic practice, understand the capabilities that need development, and move into deeper assessment, simulation, and human-reviewed verification as that role pathway becomes available.
Advanced pathways deepen by role. Verified evidence begins only after human review.
Choose your role
Start with work that reflects your target role.
Explore the available free scenarios below. Practice availability is separate from deeper simulation access and verification eligibility; neither a catalog entry nor practice completion opens a verified pathway.
Developmental scenario in the catalog
Clinical Research Coordinator
A screening visit where consent, eligibility, documentation and escalation all need a decision before the participant leaves.
CRC advanced-pathway invitation/release policy and individual eligibility apply
Developmental scenario in the catalog
Clinical Research Coordinator
A document review challenge: read one signed consent form and log the findings you would raise, with severity and domain.
CRC advanced-pathway invitation/release policy and individual eligibility apply
Developmental scenario in the catalog
Clinical Research Associate
An interim monitoring visit with a consent finding, an unreported serious event, and a product accountability gap.
CRA assessment purchase requests exist; staff eligibility and release apply
Developmental scenario in the catalog
Clinical Trial Assistant
Study start up with missing essential documents, a temperature excursion, and three files all named final.
Developmental scenario in the catalog
Clinical Data Manager
Nine days from database lock, with an implausible date, an impossible vital sign, and forty seven open queries.
Developmental scenario in the catalog
Pharmacovigilance Associate
An incoming case with a hospitalisation, a contested reporting clock, and a suspected duplicate.
Developmental scenario in the catalog
Regulatory Affairs Associate
An amendment awaiting approval, an authority question running out of days, and three protocol files all called version 3.
Developmental scenario in the catalog
Clinical Trial Manager
A study slipping against plan, with a central laboratory delay, uneven site performance, and a protocol amendment about to reshape delivery.
Developmental scenario in the catalog
Clinical Quality / GCP Auditor
An audit with a recurring consent-control failure, an incomplete root-cause analysis, and a CAPA that closes activity without proving effectiveness.
Developmental scenario in the catalog
Investigator / Principal Investigator
A busy site where delegation, an unexpected hospitalization, an eligibility question, and a staffing gap all test investigator oversight.
Developmental scenario in the catalog
Clinical Research Nurse
A study visit day with a dosing question, a vital-sign alert, a consent concern, and a sample-handling deviation.
Developmental scenario in the catalog
TMF / Essential Records Specialist
An inspection-readiness check with a missing approval, a misfiled document, an unsigned version, and a completeness metric that hides gaps.
Developmental scenario in the catalog
Clinical Scientist / Medical Monitor
A data review with a lab signal across sites, an eligibility query, a causality disagreement, and a dose decision needing medical judgment.
Capability to evidence
One pathway, with clear evidence boundaries.
The same role profile and evidence language carry forward as deeper pathway stages become available.
01
Assess
Establish a role-specific baseline and gap map.
02
Simulate
Produce observable work in defined scenarios.
03
Develop
Strengthen only the capabilities that need work.
04
Reassess
Measure progress against the same role profile.
05
Verify
Complete human review against the published standard.
06
Passport
Carry scoped evidence in a permissioned record.
07
Opportunity
Use evidence in career and workforce decisions.
Evidence progression
Know what each result means.
Practice is the multi-role entry experience. It remains distinct from baseline assessment, simulation evidence, and verified assessment.
01
Practice
A low stakes learning experience. It may be anonymous, it produces learning evidence only, and it is never verified evidence.
02
Baseline assessment
Establishes current performance and a gap map before development. Developmental, not a credential.
03
Simulation evidence
Observable actions, decisions, artifacts or communication produced in a controlled scenario. It may be carried into verification, but it is not verified on its own.
04
Verified assessment
A defined assessment reviewed under the approved human review process. Only this state can contribute verified Passport evidence.
Automated scoring may assist, but it never creates verified evidence. Verified Assessment requires the approved human-review process.
What changes for you
A clearer route from ambition to evidence.
01
Choose a role-relevant starting point
Begin with a target role and work that reflects the decisions made in that part of clinical research.
02
See strengths and development needs
Where an assessment pathway is available, results identify demonstrated capabilities, specific gaps, and areas not yet assessed.
03
Develop against the gap
Recommendations respond to what the evidence shows. They do not automatically send every professional into training.
04
Carry only supported evidence
Verified Passport evidence records the assessed scope, review state, date, version, and material limitations.
A record of what was actually assessed.
The Competency Passport distinguishes not assessed, developing, demonstrated, and verified states. It records the role and level, assessed competencies, evidence type, result, date, version, review state, and material limitations. Professionals control sharing. Practice and course completion are never presented as verified competency.
Practice never becomes Passport evidence automatically. Verified entries require the approved human-review process.
CP
Competency Passport · Fictional sample
Clinical Research Coordinator
Site operations · Participant protection · Data integrity · Safety communication
4.2 / 5Entrustable with minimal supervision
Illustrative score only
Verified2026
Employer verification
0A3F · 1B7C · 8E22
Illustrative code, not valid
Competency breakdown
Participant protection4.6
Protocol conduct4.2
Safety escalation4.4
Documentation integrity4.0
Study communication3.8
Evidence anchors
Eligibility judgment and supporting rationale
Safety escalation and follow-through
Source-to-system discrepancy resolution
Participant-facing study communication
Holder
Illustrative professional
Issued
14 Mar 2026
Valid until
14 Mar 2028
Credential ID
BKP-SAMPLE-001
Review
Human reviewed
Attempts
1 assessed attempt
Competency Labs is an independent platform. Our simulations and competency rubrics are designed to align with recognized clinical research competency frameworks, ICH-GCP principles, and global regulatory expectations. Competency Labs is not currently affiliated with, endorsed by, or accredited by IAOCR, ACRP, SOCRA, ICH, FDA, EMA, MHRA, Health Canada, TransCelerate, MRCT, ISO, or any regulatory authority unless expressly stated in a formal written partnership or accreditation notice. Learn more.
Targeted development
Close the gaps the evidence identifies.
Development may include further practice, independent study, or no development at all. Paid access never determines assessment accuracy.
01
No development needed
Performance in this competency already meets the profile. Nothing is recommended.
02
Practice recommended
Further practice in the Practice Lab against the same competency.
03
Academy learning recommended
Targeted BORAKA Academy learning against the demonstrated gap.
04
Cohort or instructor support recommended
Taught cohort or instructor support where the gap needs guided work.
05
External or self study acceptable
The gap can reasonably be closed outside BORAKA. No BORAKA purchase is required.
06
Reassessment recommended
The person is ready to be assessed again against this competency.
Support around the pathway
Use the support you need, when you need it.
Learning outside this app
Read the existing community handoff for independently delivered learning.
