Clinical Trials: Study Initiation
This eLearning module is part of the Clinical Trial Fundamentals eLearning Program and 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:
- 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.
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.
- FDA Form 1572
- Financial disclosure
- Institutional Review Board
- Informed consent and HIPAA
- Study initiation documents
- The investigator meeting
- The study initiation meeting
- Investigator study files
Who should attend?
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/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 files should be organized
The module takes an average of 2 hours to complete.