Essential Documentation Skills for Clinical Research Compliance In-house Training

Part of Responsible Conduct of Research (RCR) series:

Overview

Good Documentation Practice (GDocP) is essential for regulatory compliance, ensuring accuracy and integrity in clinical trials and laboratory work. Over time, GDocP has evolved, guided by Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA and ALCOA-plus) principles. Key aspects include maintaining essential records, proper data collection, recording, and ensuring data integrity. Reviewing, reporting, and correcting errors are also crucial for compliance. Effective document control involves handling GMP documents, data backup, retention, and implementing systems to prevent errors. Additionally, auditing and monitoring play a vital role in ensuring quality, with regular monitoring visits, Corrective and Preventive Actions (CAPA), and adverse event reporting helping maintain compliance and data reliability.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

• Understand the importance of GDocP in regulatory compliance
• Learn the GDocP essential principles
• Implement accurate, complete, and compliant records in clinical research and laboratory settings

Who should attend?

• Clinical research professionals, including clinical research associates, investigators, and study coordinators
• Medical writers, regulatory writers, and publication professionals
• Quality assurance specialists and compliance officers in pharmaceutical and clinical research organisations
• Anyone involved in clinical trial documentation, regulatory submissions, or scientific publications seeking to improve their understanding of good practices and ethical guidelines