The course outlines technical and regulatory aspects of clinical study documentation handling and SOP development. Students will learn how to organize the documents and run regulatory and clinical study administratory communication, write technical and research reports, letters, and other documents.
The course will cover the various components of an SOP, including purpose, scope, responsibilities, procedures, and documentation. Students will learn how to develop and implement SOPs that are compliant with GCP and national guidelines.
Students will learn how to write and manage different technical, business and scientific documents, research reports, and letters applying the principles of Good Documentation Practice (GDP). The course also approaches several language, structure, style, and content issues in technical writing. Students will also learn about the clinical research quality objectives, quality requirements, and quality systems.
Upon completion of the course, students will have a comprehensive understanding of clinical research SOP development and will be able to apply this knowledge to real-world situations in the clinical research industry. They will also be able to develop effective SOPs that meet regulatory requirements and ensure the safety and well-being of study participants.