CRPV110 Technical and Scientific Writing 1, Principles of GDP

The course outlines scientific and regulatory requirements for clinical research documents, procedures, and SOP development. Students will learn how to write and manage different technical, business and scientific documents, research reports, and letters while adhering to the principles of Good Documentation Practice (GDP). The course discusses the required language, structure, style, and content issues. Upon completion, students will have a practical understanding of how to write compliant scientific and technical documents and gain the necessary skills for the development of clinical research and pharmacovigilance documents including standard operating procedures (SOPs).

Learning Points:

• NIH Plain Language
• Technical and Scientific Documents, Change Control, Deviations
• Principles of Good Documentation Practices (GDP)
• Clinical Research Documents: Reports, Letters, Notifications, Memo-To-Files
• Writing Clinical Research SOPs Using Templates
• Case Management (SAE, Protocol Deviation, Drug Accountability Issue etc.)