Clinical Trials: Study Preparation
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 Trial 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.
- Responsibilities of the investigator and sponsor
- Study documents
- Clinical trial phases
- Study design
- Use of placebo
- International Council on Harmonisation
- Drug Development Legislation
- Ethical considerations in clinical research
- Responsibilities of the study staff
- The site evaluation visit
- The study budget
- The contract
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:
- Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor
- Identify the clinical phases of drug development and what is done at each phase
- Discuss the regulations and Good Clinical Practice guidelines on conducting a clinical trial
- Explain the foundations of ethical conduct in clinical research including its impact on clinical research
- Explain the history behind human subject protection
- Explain different study designs and discuss the merits of each
- Explain how to determine a study budget
The module takes an average of 2.5 hours to complete.