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Clara Fargo
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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...
Study Startup Specialist Course & Certification
Beginner
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4.7
★★★★★
96% Recommended
3 hours
187 active users
2 points
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About
The Study Startup Specialist Course is designed to provide a comprehensive understanding of clinical trial initiation processes, focusing on efficient and compliant study activation across sites. It emphasizes the critical role of startup professionals in ensuring timely approvals, site readiness, and smooth transition from study planning to execution.
This course covers key areas including feasibility and site selection, essential document collection, regulatory and ethics submissions, contract and budget coordination, and site activation workflows. It also highlights Good Clinical Practice (GCP) compliance, cross-functional collaboration, timeline management, and risk-based startup strategies to minimize delays. Upon completion, learners receive a certification demonstrating competency in clinical trial study startup operations.
Who Should Enrol?
- Study Startup Specialists and Associates
- Clinical Trial Assistants (CTAs)
- Clinical Research Associates (CRAs)
- Clinical Operations and Project Management Professionals
- Regulatory Affairs and Start-up Coordinators
- CRO and Pharmaceutical industry professionals
- Life Science, Pharmacy, Nursing, and Medical graduates
- Professionals involved in clinical trial initiation and site activation
What you will learn
Understand the fundamentals of study start-up, including the role of a start-up specialist, clinical trial lifecycle, and key milestones and metrics driving activation timelines.
Gain knowledge of medicines development, GCP principles, regulatory frameworks (EU CTR/CTIS, FDA IND, MHRA), and essential documents required for compliant trial initiation.
Learn end-to-end start-up processes including feasibility, country selection, submission strategy, contracting, ethics/IRB approvals, and site activation activities.
Develop expertise in regulatory systems, IP logistics, GDPR compliance, risk management, and audit readiness to ensure timely and compliant study activation.
Course Syllabus
- Foundations of Start-Up
- The Start-Up Specialist Role
- Milestones and Metrics
- Regulatory Context
- Discovery & Preclinical
- Clinical Phases
- Marketing Authorisation Routes
- GMP, IP and Post-launch
- Principles and History
- Sponsor & Investigator Responsibilities
- Essential Documents (E6 §8)
- IRB / EC and Informed Consent
- Risk-based & Quality-by-Design
- EU CTR / CTIS
- FDA IND
- MHRA Combined Review
- Country-specific Peculiarities
- Feasibility
- Submission Strategy
- Contracting
- Initiation & Green Light
- Operational Excellence
- The Regulatory Dossier
- The Ethics Package
- Site Essential Documents (E6 §8)
- Activation Gates
- VHP — Voluntary Harmonisation
- GDPR Fundamentals
- Controller, Processor & Joint Controller
- Subject Rights & Breach Response
- Country Selection
- Submission Sequencing
- Pre-submission Engagement
- Risks and Mitigation
- CTIS Architecture
- CTIS Workflow
- Transparency & Disclosure
- Other Disclosure Systems
- Release & Import
- Cold Chain & Controlled Substances
- Site IP Accountability
- IP Supply Risks
- Plan
- Escalate
- Communicate
- Learn & Own
- Types of Audit & Inspection
- The TMF as Evidence Base
- Top 10 Audit Findings
- Inspection Response
- 📘 Bonus: Study Startup Specialist eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
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.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
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.
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
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