This eLearning module is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. The Study Initiation module covers the various forms and documentation needed prior to beginning a clinical trial study, pre-study initiation meetings, organizing study files, and subject enrollment preparation.
This module is part of the Clinical Trial Fundamentals eLearning program which uses 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.
The Clinical Trial Fundamentals eLearning program is divided into three modules:
- Module 1: Study Preparation
- Module 2: Study Initiation
- Module 3: Conducting the Study
As learners make decisions during the clinical trial, the program explains how each scenario relates to the regulations, guidelines, and practices for conducting clinical trials.
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IACET = .2
- 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
- FDA Form 1572
- Financial Disclosure
- Institutional Review Board
- Informed Consent and HIPAA
- Continued IRB Involvement
- Study Initiation Documents
- Investigator Meeting and Study Initiation Visit
- Investigator Study Files