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About

The Study Startup Specialist (Beginner) course introduces the activities, documents and decisions that determine whether a clinical trial reaches first patient on time. The course follows the start-up lifecycle from feasibility and site selection through regulatory submissions, ethics review, contracting, and site initiation. Learners explore essential documents, ICH GCP E6(R3) responsibilities, and the operational handoffs between sponsor, CRO and site. Real-world worked examples illustrate common bottlenecks - delegation logs, essential document gaps, and ethics-to-RGO sequencing - so learners can avoid them in their own programs.

This course is recommended for clinical research associates, study coordinators, junior project managers, regulatory and start-up specialists, and anyone moving into a clinical operations role. On completion, learners will be able to plan feasibility, prepare a complete submission pack, manage ethics and regulatory review, drive contracting and site initiation, and recognise the most common start-up risks. Aligned with ICH GCP E6(R3), FDA, EMA and MHRA expectations.

Course Syllabus

  1. Foundations of Start-Up
  2. The Start-Up Specialist Role
  3. Milestones and Metrics
  4. Regulatory Context

  1. Discovery & Preclinical
  2. Clinical Phases
  3. Marketing Authorisation Routes
  4. GMP, IP and Post-launch

  1. Principles and History
  2. Sponsor & Investigator Responsibilities
  3. Essential Documents (E6 §8)
  4. IRB / EC and Informed Consent
  5. Risk-based & Quality-by-Design

  1. EU CTR / CTIS
  2. FDA IND
  3. MHRA Combined Review
  4. Country-specific Peculiarities

  1. Feasibility
  2. Submission Strategy
  3. Contracting
  4. Initiation & Green Light
  5. Operational Excellence

  1. The Regulatory Dossier
  2. The Ethics Package
  3. Site Essential Documents (E6 §8)
  4. Activation Gates

  1. VHP — Voluntary Harmonisation
  2. GDPR Fundamentals
  3. Controller, Processor & Joint Controller
  4. Subject Rights & Breach Response

  1. Country Selection
  2. Submission Sequencing
  3. Pre-submission Engagement
  4. Risks and Mitigation

  1. CTIS Architecture
  2. CTIS Workflow
  3. Transparency & Disclosure
  4. Other Disclosure Systems

  1. Release & Import
  2. Cold Chain & Controlled Substances
  3. Site IP Accountability
  4. IP Supply Risks

  1. Plan
  2. Escalate
  3. Communicate
  4. Learn & Own

  1. Types of Audit & Inspection
  2. The TMF as Evidence Base
  3. Top 10 Audit Findings
  4. Inspection Response

Course Benefits

Benefits cpd_points icon
CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with any changes to ICH GCP E6(R3), FDA 21 CFR 312, EMA Clinical Trials Regulation EU 536/2014, and MHRA guidance, as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content has been developed by experienced clinical operations and regulatory practitioners to ensure that learners can apply start-up best practice from feasibility through site initiation.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

Learner Rating & Reviews

4.7
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Average Rating
536 global ratings
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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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