The development of clinical study protocols and informed consent forms (ICFs) are essential components of clinical research. This course is designed to provide a comprehensive understanding of the principles and methods used in developing these critical documents.
Participants will learn the purpose, structure, and content of a clinical study protocol, including the essential elements required by regulatory agencies such as Health Canada, FDA, and ICH. Topics covered will include the rationale for the study, study design, inclusion and exclusion criteria, study endpoints, and statistical analysis plan.
The course will also cover the principles of developing an ICF, including the ethical considerations and regulatory requirements for informed consent. Participants will learn how to write an ICF that is clear, concise, and easy for participants to understand. They will also learn how to navigate the process of obtaining informed consent from study participants, including the elements that must be included in the consent process.
In addition to theoretical knowledge, participants will have the opportunity to engage in practical exercises to reinforce their learning. They will work on developing clinical study protocols and ICFs.
By the end of the course, participants will have a solid understanding of the key elements required for the development of clinical study protocols and ICFs. They will also have the practical skills necessary to write and develop these documents effectively, ensuring that their research is ethically and legally sound.