ICH GCP R3 is now in English & EU languages. Book Now
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About

This programme is for protocol authors, medical writers, clinical scientists, lead clinical research coordinators, regulatory associates, and quality reviewers who need practical mastery of how a protocol is built, defended, executed and amended. On completion, learners can read a protocol with audit eyes, identify and protect critical-to-quality factors, write defensible objectives, endpoints and estimands, draft inclusion/exclusion criteria that hold up under screening pressure, design a Schedule of Activities that maps cleanly to source and eCRF, draft and classify amendments correctly, and operationalise a protocol at the site without inviting deviations. The course aligns to ICH-GCP E6(R3), ICH E8(R1), ICH E9(R1), ISO 14155, FDA 21 CFR 312/812, and EU CTR 536/2014.

Course Syllabus

  1. Where ideas come from
  2. Investigator-initiated vs sponsor-led
  3. The protocol lifecycle
  4. Patterns, examples, and a case

  1. Grant vs protocol
  2. Essential protocol sections
  3. Writing for execution
  4. The six alignments
  5. Version control & amendment discipline

  1. The regulatory map
  2. Submission sequencing
  3. Roles and accountabilities
  4. Post-approval and localisation

  1. Design typology
  2. Endpoint selection
  3. Four-dimensional feasibility
  4. High-impact design elements

  1. DSMP — the operational safety document
  2. DSMB / DMC
  3. Risk-based monitoring
  4. Safety data pathway
  5. Stopping rules

  1. The data lifecycle
  2. Data Management Plan
  3. ALCOA+
  4. CRF design
  5. Reproducibility

  1. Why recruitment fails
  2. The recruitment funnel
  3. Site archetypes
  4. Retention by design
  5. Mid-study interventions

  1. Milestones
  2. The critical path
  3. Resource planning
  4. Risk management
  5. Communication cadence

  1. Governance models
  2. Country & site selection
  3. Contracts and MSAs
  4. Harmonisation vs localisation
  5. Sponsor oversight at scale

  1. Building the budget
  2. Research vs standard of care
  3. Contract negotiation
  4. Financial tracking

  1. The execution gap
  2. Site-level operational tools
  3. Cross-functional coordination
  4. Early warning signals
  5. Sponsor-site partnership

  1. The five patterns
  2. Diagnosing early
  3. Culture — name, don't blame

  1. What inspectors look for
  2. Contemporaneous documentation
  3. Deviation management
  4. Behaviour under inspection
  5. Mock inspections
  6. Course complete

Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

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