The Informed Consent Process
This course provides an in-depth overview of the informed consent process requirements from the Declaration of Helsinki, 21 CFR part 50 and ISO 14155, and offers detailed instructions for all parties involved within the writing and approval process of the informed consent before it can be implemented in a clinical investigation including details about special circumstances that may arise in the informed consent process.
This course will also review how the monitor plays a role in each of the steps and what the responsibilities are in the informed consent process on site.
Upon completion of this course, trainees will be able to:
- Review informed consent for accuracy and completeness before it is submitted to the ethics committees or IRBs and regulatory authorities.
- Perform the training of the investigation site personnel with regards to the informed consent process.
- Ensure compliance at all times during the clinical investigation including when changes are needed to 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 an emergency situation.
Monitors, clinical project managers, investigators, study coordinators. Quality assurance, regulatory and marketing professionals wanting to understand the basic requirements of the informed consent process.
An understanding of the basis of Good Clinical Practice and requirements of the declaration of Helsinki.