How to set up a clinical trial site
The practical path for medical doctors to lead clinical trials and ensure regulatory compliance as a qualified principal investigator.
⭐⭐⭐⭐⭐ 4.8 — 94 verified reviews 6,000+ certified professionals
Expert author: Adam Williams
2h 10m
Average study time
€97
Price
English
LANGUAGE
No
Final Exam
Professionals from these organisations have completed our training
Certification
Upon completion, you will receive a downloadable and shareable certification on LinkedIn that fully qualifies you to work on international clinical trials around the world.
Description
Transitioning into a Principal Investigator is one of the most rewarding steps in a medical career, but clinical expertise alone isn’t enough to run a site. You also need to manage operations, lead a team, and meet strict regulatory standards. Designed specifically for doctors, nurses, and medical teams, this course bridges the gap between your medical background and the operational requirements of a successful research center.
Across 6 practical modules, you will learn how to set up your site, streamline study workflows, build protocol compliance, and position your facility to be selected by pharma sponsors and CROs.
Many doctors have the clinical skills but lack the regulatory knowledge to lead a study. This course provides the ‘Investigator Oversight’ training required by sponsors to trust you with their protocols.
What you will learn?
Upon completion of this course, you will be able to:
- Analyze the opportunity you have to start working in clinical research;
- Comprehend the infrastructure required to conduct a clinical trial;
- Understand how to carry out feasibility studies and financial planning for clinical trials;
- Realize the importance of using Standard Operating Procedures (SOPs) in clinical trials and create your own SOPs that fit the needs of trial;
- Describe ways to attract and retain potential subjects for trials and how to confirm their eligibility;
- Understand the importance of investigator oversight and the relationship with the CRAs;
- Compare the difference between Real World Evidence (RWE) studies and Randomized Clinical Trials (RCTs)
By the end of this comprehensive course, you’ll be well-equipped to lead your medical facility towards a successful clinical trial site, contributing to groundbreaking research, offering cutting-edge treatment options to your patients, and making a significant impact on healthcare advancement.
Who should enrol?
- Medical doctors and dentists who are keen on starting a clinical trial site and taking on the role of a Principal Investigator. Whether you have little to no experience in clinical research or are an experienced physician looking to refine your site operations, this program provides the step-by-step roadmap required to transition into research leadership
- Other medical personnel (nurses, pharmacists, medical technologists or clinical laboratory scientists, imaging professionals, radiologists, raters, etc.) who want to support the opening of a clinical trial site
Curriculum
- Overview
Determine the physical and digital infrastructure needed to support your responsibilities as a Principal Investigator
Master the financial side of research, including budgeting and contract negotiation, from a principal investigator’s perspective
Learn to develop Standard Operating Procedures that protect your site and ensure your oversight as a principal investigator is documented.
Discover strategies to effectively recruit and retain study participants while ensuring their safety, the primary duty of the principal investigator. This module provides the tools a Principal Investigator needs to build a participant-centric site that meets enrollment targets without sacrificing ethical standards.
Learn best practices for site operations, staffing, and resource allocation from the perspective of a principal investigator. We explore how a principal investigator effectively delegates tasks while maintaining ultimate responsibility for the trial’s conduct and staff supervision.
Understand RWE studies
Reviews
⭐⭐⭐⭐⭐ What 6,000+ certified professionals say
FAQ: How to set up a clinical trial site
While any MD can technically lead a study, sponsors prefer a Principal Investigator who can demonstrate formal training in site management and GCP. This course provides that documented evidence of your readiness to lead as a Principal Investigator.
Under ICH GCP E6(R3), the Principal Investigator is responsible for providing adequate resources, ensuring staff are qualified, and maintaining medical oversight of all participants. This course ensures you have the infrastructure in place so that you can step into the role of Principal Investigator with total confidence
This course includes:
Downloadable certification
Lifetime access
Automated progress tracking
Discounts for teams
30-day money-back guarantee
100% Secure Payment 
30-day money-back guarantee: Try the full course risk-free. If you’re not satisfied before completing it, we’ll refund you, no questions asked.
