Description

Course Overview

Clinical trial study start-up refers to the initial phase of a clinical trial where preparations are made to initiate the study. It encompasses various activities and processes necessary to prepare the trial for execution, including protocol development, regulatory submissions, site selection, contract negotiations, and planning for participant recruitment. During this phase, key stakeholders collaborate to ensure that all necessary approvals and arrangements are in place before the trial can commence. Effective study start-up is essential for laying the foundation for a successful and well-executed clinical trial.

The Clinical Trial Study Start-Up course provides participants with comprehensive insights and practical skills necessary to navigate the complex process of initiating clinical trials. 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. Participants will learn about the key components of study start-up, including protocol development, regulatory requirements, site feasibility assessments, contract negotiation, and study initiation procedures. Through interactive lectures, case studies, and practical exercises, participants will acquire the knowledge and tools needed to effectively manage study start-up activities and optimize trial success.

Key Learning Objectives

Understand the importance and challenges of study startup in clinical trials.
Learn about the key components of study startup, including protocol development, regulatory submissions, and site selection.
Gain insights into conducting site feasibility assessments and selecting appropriate investigative sites.
Understand the regulatory requirements and documentation needed for study startup, including Institutional Review Board (IRB) approvals and regulatory submissions.
Learn effective strategies for contract negotiation with investigative sites, vendors, and other stakeholders.
Explore best practices for study initiation procedures, including investigator meetings, site training, and study startup visits.
Gain practical skills in project management, communication, and stakeholder coordination during study startup.

Course Structure

The course is delivered through a combination of online lectures, instructor-led case studies, live group discussions, and interactive activities, spanning approximately 60 hours.

The lectures, exams, and supplementary materials are structured to be finished at your own pace. The practical masterclasses are conducted in real-time and have set schedules. For the most up-to-date information regarding masterclass schedules for this course, please reach out to us directly at info@clueoclinical.com. You’ll have up to 6 months from the onboarding date to finish all aspects of the course.

Target Audience

This course is ideal for clinical research professionals involved in study start-up activities, including clinical research associates (CRAs), Clinical Study Start-Up Specialist (SSU), initiation Clinical Site Manager (iCSM), project managers, study coordinators (CRC), regulatory affairs professionals, and others responsible for initiating and managing clinical trials. No previous experience in clinical research is required. However, it’s important to note that this course exclusively focuses on providing an understanding of the start-up phase of a clinical trial, and does not encompass all the knowledge needed to be a Clinical Study Start-Up Specialist or an iCSM. For a more comprehensive program, please refer to our signature Industry-Bridging programs.

Prerequisite

Having prior knowledge of ICH-GCP guidelines and the regulatory framework governing clinical trials is beneficial as it enables you to apply this knowledge effectively for initiating clinical trials.

Certification

To receive the completion certificate for the course, you must achieve a minimum score of ≥ 80% on all assessments.
You have the opportunity to attempt the final course exam twice. If you do not pass after both attempts, you will be required to retake the entire course from the beginning.

Upon meeting these criteria, your certificate of successful completion will be awarded within 48 hours of course completion.

Course Fee

Full fee: $928 inc. GST *

Industry Partner: $742 inc. GST *

Member: $789 inc. GST *

(*Prices are subject to the indexation rate set by the Australian Taxation Office to account for inflation)

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