A path from foundations to career evidence.
The catalog is organised as a journey. It starts with how a study actually runs, builds through site, data, monitoring and trial management work, and ends with presenting your experience honestly and leading well.
Every course is still in development and marked Coming soon. Nothing here is open for enrollment yet, and no course carries a certificate at this stage.
Foundations & Operational Judgment
How a study actually runs, who owns what, and how decisions get made under pressure.
- FoundationComing soon
Clinical Research Workflow: Who Owns What, and When?
Follow a fictional study across site, sponsor, CRO and vendors, and see where responsibility actually sits at each step.
You will produce: A responsibility and handoff map for a fictional study.
- FoundationComing soon
GCP in Real Work: ICH E6(R3) Decision-Making
Work through the everyday decisions where good clinical practice is either applied or quietly skipped.
You will produce: A set of documented GCP decisions with the reasoning behind each one.
- FoundationComing soon
Protocol to Practice: Build a Study Execution Plan
Turn a fictional protocol into the practical plan a study team can actually run from.
You will produce: A visit schedule, responsibility map, operational checklist and clarification log.
- PractitionerComing soon
Clinical Research Prioritization: Manage a High-Pressure Study Day
Decide what comes first when participant, safety, documentation and timeline demands all arrive at once.
You will produce: A prioritized action plan with the reasoning for each decision.
- PractitionerComing soon
Site–CRO–Sponsor Communication: Make the Handoff Work
Write the message that gets a decision, and close the loop so nothing falls between organizations.
You will produce: An escalation email, a structured handoff and an action log.
Site Operations & Participant Experience
Consent, eligibility, visits, recruitment and investigational product work at the site.
- FoundationComing soon
Study Visit Planning: Align Windows, Procedures, and People
Prepare a study visit so procedures, windows, staff and dependencies line up before the participant arrives.
You will produce: A visit-preparation pack for a fictional study visit.
- PractitionerComing soon
Eligibility Review: Resolve Ambiguity Before Enrollment
Work an ambiguous eligibility case to the evidence, and know which questions belong with the investigator.
You will produce: An eligibility evidence matrix with open questions flagged for investigator review.
- PractitionerComing soon
Informed Consent in Practice: Difficult Conversations and Reconsent
Handle the consent conversations that are not straightforward, and document reconsent properly.
You will produce: A consent conversation approach and a documented reconsent workflow.
- PractitionerComing soon
Investigational Product Accountability: Investigate a Reconciliation Gap
Trace an accountability discrepancy back through the records and escalate it correctly.
You will produce: A documented discrepancy investigation and escalation note.
- PractitionerComing soon
Recruitment and Retention: Fix the Bottleneck Without Pressuring Participants
Find where a fictional recruitment funnel is losing people, and improve it without pressure tactics.
You will produce: A funnel analysis and an improvement plan.
Data, Documentation & Clinical Systems
Source records, EDC, the trial master file and the systems that hold the trial record.
- FoundationComing soon
Clinical Systems Literacy: Follow the Information Across EDC, CTMS, and eTMF
Learn where each piece of study information belongs, and what happens when it is only in one place.
You will produce: An information flow map across study systems.
- FoundationComing soon
Regulatory Document Readiness: Build a Site Activation Pack
Assemble a fictional site document package and quality-check it before anyone else has to.
You will produce: A site activation document pack with a completeness check.
- PractitionerComing soon
Source-to-EDC Data Quality: Resolve Discrepancies and Queries
Compare source records with entered data, work out what really happened, and answer queries with evidence.
You will produce: A discrepancy review and drafted query responses.
- PractitionerComing soon
TMF Quality Control: Reconstruct a Complete, Traceable Trial Record
Review a mock trial master file and tell a real gap apart from something that simply does not apply.
You will produce: A TMF gap review and remediation tracker.
- AdvancedComing soon
Data Review and Reconciliation: Prepare for Database Lock
Work unresolved issues down to a defensible recommendation on whether a study is ready to lock.
You will produce: A discrepancy tracker and a lock readiness recommendation.
Monitoring, Quality & Inspection Readiness
Evidence-based findings, deviations, CAPA, signals and defending the record.
- PractitionerComing soon
Monitoring Judgment: Turn Evidence into Defensible Findings
Separate what you noticed from what you can evidence, and rank what actually needs follow-up.
You will produce: A prioritized findings list with the supporting evidence for each item.
- PractitionerComing soon
Monitoring Reports: Write Findings People Can Act On
Turn rough visit notes into a report a site can act on without a second phone call.
You will produce: A monitoring report with findings, actions and owners.
- PractitionerComing soon
Protocol Deviations and CAPA: Investigate and Prevent Recurrence
Get past the first explanation of a deviation and build a corrective plan that holds.
You will produce: A deviation investigation and CAPA plan including an effectiveness check.
- AdvancedComing soon
Centralized Monitoring: Turn Site Signals into Review Priorities
Read site-level indicators for what they can and cannot tell you, then decide where to look.
You will produce: A signal review with prioritized investigation recommendations.
- AdvancedComing soon
Inspection Readiness: Defend the Record in a Mock Inspection
Answer inspection-style questions from the record itself, and see where the record does not hold up.
You will produce: An inspection question set answered from the record, with a gap list.
Trial Management & Sponsor Operations
Risk, start-up, budgets, vendor oversight and recovering a study that is behind.
- PractitionerComing soon
Clinical Trial Risk Management: Build a Decision-Ready Risk and Issue Log
Convert a messy study update into risks, issues, owners and the decisions that need making now.
You will produce: A prioritized risk and issue log with owners and escalation decisions.
- PractitionerComing soon
Study Start-Up: Find and Fix Activation Bottlenecks
See which start-up dependency is really holding activation, and sequence the recovery.
You will produce: A start-up dependency map and recovery sequence.
- AdvancedComing soon
CRO and Vendor Oversight: Challenge a Green Dashboard
Ask what a reassuring status report is not showing, and prepare the oversight conversation.
You will produce: An oversight question set and evidence request list.
- AdvancedComing soon
Enrollment Recovery: Build a Credible Study Rescue Plan
Test the assumptions behind a slipping enrollment plan before promising a recovery.
You will produce: An enrollment recovery plan with tradeoffs stated.
- AdvancedComing soon
Trial Budgets and Change Orders: Test Assumptions and Explain Variance
Check what a budget assumed, find where reality diverged, and explain the difference in writing.
You will produce: A variance explanation or change-order justification.
Safety, Scientific & Medical Communication
Case intake, narratives, medical information and appraising clinical evidence.
- FoundationComing soon
Safety Case Intake: Capture Missing Information and Escalate Appropriately
Take an incomplete safety report and work out what is missing and what cannot wait.
You will produce: A case-intake record and follow-up question set.
- PractitionerComing soon
Clinical Evidence Appraisal: Explain What a Study Does and Does Not Show
Read a study for its question, design and limits, then say plainly what it supports.
You will produce: A one-page evidence brief.
- PractitionerComing soon
Medical Information: Draft a Balanced, Referenced Response
Answer a fictional inquiry accurately, without promotion, and with the sources shown.
You will produce: A referenced inquiry response with a review route.
- PractitionerComing soon
Safety Narratives and Reconciliation: Build a Traceable Case
Write a factual case narrative and reconcile the places where the sources disagree.
You will produce: A case narrative with a reconciliation summary and open items.
- AdvancedComing soon
Oncology Trial Operations: Coordinate Biomarkers, Assessments, and Safety Workflows
Coordinate the assessments, biomarker work and safety steps an oncology study depends on.
You will produce: An oncology study operational plan with dependencies and escalation points.
Labs, Technology & Complex Trial Operations
Biospecimens, amendments, AI-assisted work, decentralized trials and device studies.
- PractitionerComing soon
AI-Assisted Clinical Research Work: Verify the Output and Protect the Information
Check an AI-generated work product properly, and decide what information should never be pasted into a tool.
You will produce: A verification record and information-handling decision note.
- PractitionerComing soon
Central Lab and Biospecimen Operations: Prevent Sample-to-Data Failures
Follow a sample from collection to result, and investigate the point where it went wrong.
You will produce: A sample journey map and a failure investigation.
- PractitionerComing soon
Decentralized Trial Operations: Close Gaps in the Remote Participant Journey
Map a remote participant journey and find the handoffs where support and data quietly drop.
You will produce: A remote participant journey map with responsibilities and contingencies.
- PractitionerComing soon
Medical Device Study Operations: Manage Accountability and Follow-Up
Run the tracking and follow-up a device study needs, from allocation to long-term checks.
You will produce: A device study operational checklist and tracking log.
- AdvancedComing soon
Protocol Amendments: Control Change Across Sites, Systems, and Vendors
Work out everything an amendment touches, then track it to done across every affected party.
You will produce: An amendment impact assessment and implementation tracker.
Career Evidence, Progression & Leadership
Presenting your work honestly, moving between site, CRO and sponsor, and leading well.
- FoundationComing soon
Clinical Research Career Decisions: Compare Technical and Management Paths
Compare a deeper technical path with a management path against how you actually like to work.
You will produce: A career decision brief.
- FoundationComing soon
Clinical Research Evidence Portfolio: Present Your Work Honestly
Assemble your practice work into a portfolio that is clear about what it is and what it is not.
You will produce: A portfolio of practice work with an honest scope statement.
- PractitionerComing soon
Leading Without Authority: Resolve a Study-Team Conflict
Prepare and hold the conversation nobody wants, then write down what was agreed.
You will produce: A conversation plan and a documented agreement of responsibilities.
- PractitionerComing soon
Site-to-CRO Transition: Translate Experience Without Inflating It
Map what you have really done at a site to CRO responsibilities, and name the gaps yourself.
You will produce: An experience mapping document with gaps and prepared examples.
- AdvancedComing soon
Sponsor-Side Transition: Practice Oversight Rather Than Task Execution
Shift from doing the task to asking the questions that keep delivery honest.
You will produce: A sponsor oversight question set with decisions and follow-up expectations.
The path ends in evidence, not just lessons.
Each course ends in a work product you keep. Together they build toward the verified competency record that Competency Labs and, in future, BORAKA Assess are designed around.