Yoshe Clinical Academy | Role-based clinical research training for sites, CROs and sponsors
Yoshe Clinical AcademyFoundation Layer of Yoshe TriQ™
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Role-based clinical research training for sites, CROs and sponsors

CPD-accredited courses built around the job each person actually does, from Principal Investigator to Clinical Research Associate to Pharmacovigilance Manager, with therapeutic area training added when they join a study.

Find your training pathway Talk to the Academy

159 courses for 98 roles across 23 functions. Self-learning courses from £100.00.

CPD Member, The CPD Certification ServiceCPD-accredited courses
The CPD Certification Service

One curriculum, six regulatory authorities

  • FDAUnited States
  • EMAEuropean Union / EEA
  • MHRAUnited Kingdom
  • CDSCOIndia
  • NMPAChina
  • PMDAJapan

Built for every organisation in a clinical trial

Every regulator expects the sponsor and the investigator to show that each person was qualified by education, training and experience for their duty at the time they performed it. Our role-based curriculum gives you that evidence.

Clinical research sites

Hospitals, academic research units and investigator sites

For your site

  • One curriculum for PIs, sub-investigators, coordinators, research pharmacy, regulatory and quality staff
  • Training records that back up your delegation log at monitoring visits and inspections
  • A stronger feasibility response when sponsors assess your site

For your people

  • CPD certificates they keep as they move between studies and employers
  • A clear route from research assistant to coordinator to site manager

CROs

Full-service, functional service and niche providers

For your organisation

  • Consistent onboarding for CRAs, project managers, data managers and start-up teams in every country
  • Audit-ready competency evidence when sponsors qualify you as a vendor
  • Therapeutic area training assigned when staff join a study

For your people

  • Faster progression from in-house CRA to lead CRA and study management
  • Refresher courses that keep GCP and safety knowledge current

Sponsors, pharma and biotech

Clinical operations, safety, regulatory and quality teams

For your organisation

  • Oversight you can evidence: the same standard across your own teams, CROs, vendors and sites
  • Every course is linked to a controlled SOP, and you can map your own SOP numbers to it
  • Six jurisdictions covered in one programme for global studies

For your people

  • Specialist tracks in pharmacovigilance, regulatory affairs, medical monitoring and QA
  • Advanced courses that prepare them to lead studies and programmes

Find your training pathway

Choose where you work and your role. We'll show the courses assigned to that role and the hours involved.

Where do you work?

Programmes and prices

Start with the Foundation curriculum, then add the programme for your function. Prices are for self-learners.

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Foundation curriculum of clinical research

14 core courses, 20.5 hours. Required for every role before independent work on a clinical trial: GCP ICH E6(R3), ICH E8(R1), ethics, informed consent, data integrity, data privacy, safety reporting, inspection readiness and the six-jurisdiction regulatory landscape.

Clinical research site programmes

CRO, sponsor, pharma and biotech programmes

Medical devices

Programme prices are 15% below buying the courses singly. With Foundation curriculum prices cover the complete role pathway at 25% below buying singly. Single courses from £100.00. Prices exclude VAT, GST and sales taxes. Teams, sites, CROs and sponsors: ask for a corporate proposal. India, China, Australia and New Zealand learners: ask for your local price list.

Course catalogue

Every learner starts with the core curriculum, adds the courses for their function, then adds a therapeutic area path when assigned to a study.

Fourteen courses, 20.5 hours, mandatory for every role before independent work on a clinical trial.

Code Course Minutes

Build a career, one level at a time

Courses are set at three levels. Each level assumes the one before it, so training grows with the responsibility of the role.

Level 1Foundation

Recall and explain the principle and recognise when it applies. The core curriculum, taken on appointment.

Level 2Practitioner

Apply it independently to your own work and produce the record or deliverable to standard.

Level 3Advanced

Exercise judgement in ambiguous situations, defend a decision and oversee the work of others.

At a clinical research site

  1. Research assistant or data entryCore curriculum plus coordinator courses
  2. Clinical research coordinator or study nurseFull coordinator programme and therapeutic area path
  3. Site regulatory or research pharmacy leadEthics dossier, IP custody and unblinding courses
  4. Site manager or research operations managerSite quality system, CAPA and inspection readiness

At a CRO

  1. Clinical trial assistant or in-house CRACore curriculum plus monitoring fundamentals
  2. Clinical research associateFull CRA programme, SDV, IP accountability and visit reports
  3. Lead CRA or central monitorRisk-based and centralised monitoring (Level 3)
  4. Clinical trial managerMonitoring oversight, deviations and six-jurisdiction operations
  5. Project manager or project directorGovernance, budgets, vendor oversight and hybrid trial models

At a sponsor

  1. Associate: drug safety, regulatory or QACore curriculum plus the function's practitioner courses
  2. Specialist or scientistExpedited reporting, submissions or CAPA across jurisdictions
  3. ManagerAggregate reporting, GCP auditing or inspection management (Level 3)
  4. Clinical operations lead or programme leadSponsor oversight of CROs and vendors under ICH E6(R3)

Aligned to the global regulatory landscape

Where requirements differ between jurisdictions, each position is taught separately and learners are shown which one applies to their study.

Jurisdiction Authority Principal framework What the training covers
United States FDA (CDER / CBER) 21 CFR Parts 11, 50, 54, 56 and 312; ICH E6(R3) GCP currency and role competence; investigator delegation and financial disclosure
European Union / EEA EMA and national competent authorities Regulation (EU) 536/2014; CTIS; EudraLex Volume 10; ICH E6(R3) Evidence that each individual is qualified for their delegated task
United Kingdom MHRA and HRA Medicines for Human Use (Clinical Trials) Regulations 2004, as amended; UK combined review The proportionate-risk model and serious breach notification
India CDSCO / DCGI New Drugs and Clinical Trials Rules 2019; CTRI; ICMR National Ethical Guidelines; DPDP Act 2023 Investigator and site training records; ethics committee registration and reporting
China NMPA / NHC Drug Administration Law 2019; China GCP 2020; Human Genetic Resources regulations HGRAC approval, the 60-working-day implied CTA licence and local safety reporting
Japan PMDA / MHLW PMD Act; J-GCP Ordinance (MHLW Ordinance No. 28); Clinical Trial Notification The CTN pathway, the site IRB model and Japan-specific documentation

All six authorities expect you to show that every person performing a trial duty was qualified by education, training and experience at the time. Your curriculum assignment record and signed training records are that evidence.

Ways to learn

Learn on your own schedule, train a whole team, or partner with us as an institution.

Self-learning

From £100.00 per course

For individuals building or refreshing their skills.

  • Online, at your own pace
  • Practice quizzes with instant feedback
  • CPD certificate on passing the final assessment
Enquire about a course

Corporate programmes

Priced per cohort

For sites, CROs and sponsors training teams to a common standard.

  • On-site, live remote or blended delivery
  • Curriculum assigned by role, with your SOPs mapped
  • Training records ready for audit and inspection
Request a team proposal

Academic and institutional

Partnership

For universities, hospitals and public health bodies.

  • CPD-accredited curriculum for students, faculty and research staff
  • Role-based pathways for your research workforce
  • Delivery planned around your academic calendar
Discuss a partnership
CPD Member, The CPD Certification ServiceCPD-accredited

Hours claimed match the published course index exactly.

80% pass mark

Invigilated final assessment, with remediation and re-sit if needed.

Kept current

Refresher cycles of one or two years, and review on regulatory change.

Accessible

Materials produced to WCAG 2.2 AA. Alternative formats on request at no cost.

Yoshe Clinical Operations

Talk to the Academy

Tell us about your team or the course you're interested in, and we'll reply by email with a training plan and pricing.

Email us directly

[email protected]

Yoshe Clinical Academy, the Foundation Layer of Yoshe TriQ™

Yoshe Clinical Operations Ltd. Registered in England and Wales, company no. 07792526. ICO registered.

CPD Member, The CPD Certification Service

[email protected]

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