Individual, self-paced courses in clinical research, separate from the structured programs. Each one is built around a decision you will actually have to make, and each one ends in a work product you keep.
These courses are in development. Nothing here is open for enrollment yet, and no course listed on this page carries a certificate at this stage.
Every course names who it is for, what you will be able to do afterwards, and what you will produce.
Showing 40 of 40 courses.
Foundations & Operational Judgment
Coming soonFollow a fictional study across site, sponsor, CRO and vendors, and see where responsibility actually sits at each step.
Foundation · Self-paced
You will produce: A responsibility and handoff map for a fictional study.
Foundations & Operational Judgment
Coming soonTurn a fictional protocol into the practical plan a study team can actually run from.
Foundation · Self-paced
You will produce: A visit schedule, responsibility map, operational checklist and clarification log.
Foundations & Operational Judgment
Coming soonWork through the everyday decisions where good clinical practice is either applied or quietly skipped.
Foundation · Self-paced
You will produce: A set of documented GCP decisions with the reasoning behind each one.
Foundations & Operational Judgment
Coming soonDecide what comes first when participant, safety, documentation and timeline demands all arrive at once.
Practitioner · Self-paced
You will produce: A prioritized action plan with the reasoning for each decision.
Foundations & Operational Judgment
Coming soonWrite the message that gets a decision, and close the loop so nothing falls between organizations.
Practitioner · Self-paced
You will produce: An escalation email, a structured handoff and an action log.
Site Operations & Participant Experience
Coming soonHandle the consent conversations that are not straightforward, and document reconsent properly.
Practitioner · Self-paced
You will produce: A consent conversation approach and a documented reconsent workflow.
Site Operations & Participant Experience
Coming soonWork an ambiguous eligibility case to the evidence, and know which questions belong with the investigator.
Practitioner · Self-paced
You will produce: An eligibility evidence matrix with open questions flagged for investigator review.
Site Operations & Participant Experience
Coming soonPrepare a study visit so procedures, windows, staff and dependencies line up before the participant arrives.
Foundation · Self-paced
You will produce: A visit-preparation pack for a fictional study visit.
Site Operations & Participant Experience
Coming soonFind where a fictional recruitment funnel is losing people, and improve it without pressure tactics.
Practitioner · Self-paced
You will produce: A funnel analysis and an improvement plan.
Site Operations & Participant Experience
Coming soonTrace an accountability discrepancy back through the records and escalate it correctly.
Practitioner · Self-paced
You will produce: A documented discrepancy investigation and escalation note.
Data, Documentation & Clinical Systems
Coming soonCompare source records with entered data, work out what really happened, and answer queries with evidence.
Practitioner · Self-paced
You will produce: A discrepancy review and drafted query responses.
Data, Documentation & Clinical Systems
Coming soonReview a mock trial master file and tell a real gap apart from something that simply does not apply.
Practitioner · Self-paced
You will produce: A TMF gap review and remediation tracker.
Data, Documentation & Clinical Systems
Coming soonAssemble a fictional site document package and quality-check it before anyone else has to.
Foundation · Self-paced
You will produce: A site activation document pack with a completeness check.
Data, Documentation & Clinical Systems
Coming soonLearn where each piece of study information belongs, and what happens when it is only in one place.
Foundation · Self-paced
You will produce: An information flow map across study systems.
Data, Documentation & Clinical Systems
Coming soonWork unresolved issues down to a defensible recommendation on whether a study is ready to lock.
Advanced · Self-paced
You will produce: A discrepancy tracker and a lock readiness recommendation.
Monitoring, Quality & Inspection Readiness
Coming soonSeparate what you noticed from what you can evidence, and rank what actually needs follow-up.
Practitioner · Self-paced
You will produce: A prioritized findings list with the supporting evidence for each item.
Monitoring, Quality & Inspection Readiness
Coming soonTurn rough visit notes into a report a site can act on without a second phone call.
Practitioner · Self-paced
You will produce: A monitoring report with findings, actions and owners.
Monitoring, Quality & Inspection Readiness
Coming soonGet past the first explanation of a deviation and build a corrective plan that holds.
Practitioner · Self-paced
You will produce: A deviation investigation and CAPA plan including an effectiveness check.
Monitoring, Quality & Inspection Readiness
Coming soonRead site-level indicators for what they can and cannot tell you, then decide where to look.
Advanced · Self-paced
You will produce: A signal review with prioritized investigation recommendations.
Monitoring, Quality & Inspection Readiness
Coming soonAnswer inspection-style questions from the record itself, and see where the record does not hold up.
Advanced · Self-paced
You will produce: An inspection question set answered from the record, with a gap list.
Trial Management & Sponsor Operations
Coming soonConvert a messy study update into risks, issues, owners and the decisions that need making now.
Practitioner · Self-paced
You will produce: A prioritized risk and issue log with owners and escalation decisions.
Trial Management & Sponsor Operations
Coming soonSee which start-up dependency is really holding activation, and sequence the recovery.
Practitioner · Self-paced
You will produce: A start-up dependency map and recovery sequence.
Trial Management & Sponsor Operations
Coming soonCheck what a budget assumed, find where reality diverged, and explain the difference in writing.
Advanced · Self-paced
You will produce: A variance explanation or change-order justification.
Trial Management & Sponsor Operations
Coming soonAsk what a reassuring status report is not showing, and prepare the oversight conversation.
Advanced · Self-paced
You will produce: An oversight question set and evidence request list.
Trial Management & Sponsor Operations
Coming soonTest the assumptions behind a slipping enrollment plan before promising a recovery.
Advanced · Self-paced
You will produce: An enrollment recovery plan with tradeoffs stated.
Safety, Scientific & Medical Communication
Coming soonTake an incomplete safety report and work out what is missing and what cannot wait.
Foundation · Self-paced
You will produce: A case-intake record and follow-up question set.
Safety, Scientific & Medical Communication
Coming soonWrite a factual case narrative and reconcile the places where the sources disagree.
Practitioner · Self-paced
You will produce: A case narrative with a reconciliation summary and open items.
Safety, Scientific & Medical Communication
Coming soonAnswer a fictional inquiry accurately, without promotion, and with the sources shown.
Practitioner · Self-paced
You will produce: A referenced inquiry response with a review route.
Safety, Scientific & Medical Communication
Coming soonRead a study for its question, design and limits, then say plainly what it supports.
Practitioner · Self-paced
You will produce: A one-page evidence brief.
Safety, Scientific & Medical Communication
Coming soonCoordinate the assessments, biomarker work and safety steps an oncology study depends on.
Advanced · Self-paced
You will produce: An oncology study operational plan with dependencies and escalation points.
Labs, Technology & Complex Trial Operations
Coming soonFollow a sample from collection to result, and investigate the point where it went wrong.
Practitioner · Self-paced
You will produce: A sample journey map and a failure investigation.
Labs, Technology & Complex Trial Operations
Coming soonWork out everything an amendment touches, then track it to done across every affected party.
Advanced · Self-paced
You will produce: An amendment impact assessment and implementation tracker.
Labs, Technology & Complex Trial Operations
Coming soonCheck an AI-generated work product properly, and decide what information should never be pasted into a tool.
Practitioner · Self-paced
You will produce: A verification record and information-handling decision note.
Labs, Technology & Complex Trial Operations
Coming soonMap a remote participant journey and find the handoffs where support and data quietly drop.
Practitioner · Self-paced
You will produce: A remote participant journey map with responsibilities and contingencies.
Labs, Technology & Complex Trial Operations
Coming soonRun the tracking and follow-up a device study needs, from allocation to long-term checks.
Practitioner · Self-paced
You will produce: A device study operational checklist and tracking log.
Career Evidence, Progression & Leadership
Coming soonAssemble your practice work into a portfolio that is clear about what it is and what it is not.
Foundation · Self-paced
You will produce: A portfolio of practice work with an honest scope statement.
Career Evidence, Progression & Leadership
Coming soonMap what you have really done at a site to CRO responsibilities, and name the gaps yourself.
Practitioner · Self-paced
You will produce: An experience mapping document with gaps and prepared examples.
Career Evidence, Progression & Leadership
Coming soonShift from doing the task to asking the questions that keep delivery honest.
Advanced · Self-paced
You will produce: A sponsor oversight question set with decisions and follow-up expectations.
Career Evidence, Progression & Leadership
Coming soonPrepare and hold the conversation nobody wants, then write down what was agreed.
Practitioner · Self-paced
You will produce: A conversation plan and a documented agreement of responsibilities.
Career Evidence, Progression & Leadership
Coming soonCompare a deeper technical path with a management path against how you actually like to work.
Foundation · Self-paced
You will produce: A career decision brief.
These groups are how the catalog is browsed. They are separate from the six Academy professional pathways.
Foundations & Operational Judgment
How a study actually runs, who owns what, and how decisions get made under pressure.
Site Operations & Participant Experience
Consent, eligibility, visits, recruitment and investigational product work at the site.
Data, Documentation & Clinical Systems
Source records, EDC, the trial master file and the systems that hold the trial record.
Monitoring, Quality & Inspection Readiness
Evidence-based findings, deviations, CAPA, signals and defending the record.
Trial Management & Sponsor Operations
Risk, start-up, budgets, vendor oversight and recovering a study that is behind.
Safety, Scientific & Medical Communication
Case intake, narratives, medical information and appraising clinical evidence.
Labs, Technology & Complex Trial Operations
Biospecimens, amendments, AI-assisted work, decentralized trials and device studies.
Career Evidence, Progression & Leadership
Presenting your work honestly, moving between site, CRO and sponsor, and leading well.
