Clinical Trial Fundamentals: Study Initiation
hosted byDrug Information Association (DIA)Clinical Trial Fundamentals: Study Initiation is organized by Drug Information Association (DIA).
Release Date: September 28, 2022
Expiration Date: September 28, 2025
Course Description:
The module is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. Using an interactive case study with realistic scenarios designed to illustrate the learning points, the program follows the activities of a fictitious clinical investigator and her staff as they conduct a clinical trial.
Featured topics:
• FDA Form 1572
• Financial Disclosure
• Institutional Review Board
• Informed Consent and HIPAA
• Continued IRB Involvement
• Study Initiaion Documents
• Investigator Meeting and Study Initiation Visit
• Investigator Study Files
Learning objectives:
Upon completion of this module, learners should be able to:
• Define the roles and responsibilities of the Institutional Review Board or Independent Ethics Committee
• Evaluate the correct way to complete the FDA Form 1572
• List financial disclosure requirements of the clinical investigator and study staff
• Distinguish the elements of the informed consent document, including HIPAA authorization
• Identify the documents necessary to submit to the IRB before a study begins
• Determine the purpose, attendees, and activities of the study initiation meeting and the investigator meeting
• Analyze how clinical trial study files should be organized before the study starts
