The Informed Consent Process
This course provides an in-depth review of the informed consent process requirements for the Declaration of Helsinki, the ISO 14155 standard, and 21 CFR 50. It offers detailed instructions on the writing and approval processes that must be implemented before clinical investigations begin, including details about special circumstances that may arise during the informed consent process.
This course also reviews the monitor’s role and the responsibilities of performing an informed consent process on site.
Upon successfully completing this course, learners will be able to:
- Review informed consent documents for accuracy and completeness before they are submitted to ethics committees, independent review boards, or regulatory authorities
- Perform investigation site personnel training with regard to the informed consent process
- Ensure compliance at all times during clinical investigations, including when changes must be made the informed consent document
- Manage the logistics of the informed consent process when special circumstances arise or when the clinical investigation plan includes subjects in emergency situations
Monitors, clinical project managers, investigators, study coordinators, and quality assurance, regulatory, and marketing professionals wanting to understand the basic requirements of the informed consent process are all encouraged to enroll in this course.
An understanding of the basis of good clinical practice and the requirements of the Declaration of Helsinki is required for this course.