Clinical Trial Fundamentals: Study Initiation
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.
The Clinical Trials Fundamentals eLearning Program is divided into three modules:
- Clinical Trials: Study Preparation
- Clinical Trials: Study Initiation
- Clinical Trials: 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.
This ICH E6 R2 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
The module takes an average of 3 hours to complete.
This eLearning module can be purchased individually or as part of the Clinical Trial Fundamentals eLearning Program or Clinical Trial Management Comprehensive eLearning Bundle.
- 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
This module is designed for those working for investigative site teams, sponsors, or CROs, including clinical investigators, research coordinators, office coordinators, nurses, physician assistants, clinical research coordinators, and other professional involved in clinical trials.
- Physician assistants
- Nurse practitioners
- Research scientists
- Clinical research professionals
Upon completion of this module, learners should be able to:
- Describe the roles and responsibilities of the Institutional Review Board or Independent Ethics Committee
- Explain the correct way to complete the FDA Form 1572
- Describe financial disclosure requirements of the clinical investigator and study staff
- Identify the elements of the informed consent document, including HIPAA authorization
- Identify the documents necessary to submit to the IRB before a study begins
- Identify the purpose, attendees, and activities of the study initiation meeting and the investigator meeting
- Explain how clinical trial study files should be organized before the study starts