Course Overview
Clinical trial initiation, also known as the study start-up phase, is a critical stage that sets the foundation for trial success. This phase includes essential activities such as site selection, feasibility assessments, regulatory submissions, and site activation, all requiring meticulous planning and execution to ensure audit readiness and compliance. It is often the most resource-intensive and time-sensitive period of a clinical trial. Inefficiencies or non-compliance during this phase can lead to costly delays, failed audits, and compromised trial integrity. Mastering trial initiation ensures:
- Timely site activation and patient enrolment.
- Full compliance with regulatory and ethical requirements.
- Smooth transitions into subsequent trial phases.
The Study Start-Up Training for Clinical Research Professionals equips members of the clinical operations and/or startup teams from sponsors and sites with the skills and knowledge to navigate the complexities of trial start-up effectively. From project planning to site selection, regulatory submissions, and study initiation, this course covers essential practices and strategies essential for ensuring successful study start-up. Through interactive modules and practical exercises, this course provides participants with actionable insights to optimise study start-up timelines, mitigate delays, and achieve seamless trial initiation.
Key Learning Objectives
Upon completion of this course, you will:
- Understand the core components of clinical trial initiation and their impact on overall trial success.
- Master site selection strategies, feasibility assessments, and site activation processes.
- Learn best practices for managing regulatory submissions and documentation.
- Develop skills to ensure audit readiness and compliance during the start-up phase.
- Identify potential bottlenecks in trial initiation and strategies to mitigate them.
- Gain practical experience through recorded simulations of start-up scenarios.
- Build effective communication strategies for collaborating with sites, CROs, and stakeholders.
Course Structure
This course is designed for busy professionals and is delivered through online, self-paced learning with recorded simulations that provide real-life scenarios for effective learning. The course includes:
- Interactive modules covering study start-up essentials.
- Recorded simulations and real-world case studies to apply your learning to practical scenarios.
- Quizzes and assignments to help reinforce your understanding and ensure retention of critical information.
- Final assessment to evaluate your knowledge and award certification upon successful completion.
- Downloadable Resources: Templates, checklists, and guides.
- Mode: 100% Online, Self-Paced
- Duration: Approximately 12 hours
Who Should Enrol?
This course is ideal for:
- Any team members involved in trial planning and initiation
- Clinical Trial Managers
- Clinical Project Managers
- Regulatory Affairs Specialists
- Clinical Operations Professionals
- Professionals transitioning into clinical research roles
- Clinical Research Associates (CRAs)
- Clinical Trial Assistants (CTAs)
- Study Coordinators or Clinical Research Coordinators (CRCs)
It’s important to note that this course exclusively focuses on understanding and execution sof the start-up phase of a clinical trial and does not encompass all the knowledge needed to be a Clinical Study Start-Up Specialist (SSU) (aka an iCSM), or to be a Clinical Research Coordinator (CRC). For a more comprehensive, role-specific program, please refer to our award-winning Industry-Bridging programs.
Prerequisite
- A bachelor’s degree or equivalent qualification in a relevant field (e.g., Life Sciences, Nursing, or related disciplines).
- Familiarity with basic clinical trial processes and terminology is recommended but not mandatory.
Certification Requirements
- A minimum score of 80% on the final assessment is required to receive the certification.
- Learners have two attempts to pass the assessment. If additional attempts are needed, a fee will apply.
Course Fee
- Cost: $495 AUD inc. GST (12-month access to materials and resources)
- Discounts: Available for group enrolments and members (10%-30% off)
- For all inquiries, please contact info@citium.academy