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Essential records are the backbone of every clinical trial - the documents that tell the story of how a study was designed, conducted, and validated. They serve as proof of compliance with Good Clinical Practice (GCP) and regulatory requirements, ensuring that data is credible and that the rights and safety of trial participants are protected. Without accurate, complete, and well-maintained essential records, no clinical trial can stand up to scrutiny. Mastering Essential Records, a 2-part series of courses, is designed to give you a clear, practical understanding of the documentation that underpins high-quality research. Whether you in a monitoring role or part of the trial conduct team at site, you will gain the knowledge and confidence to manage essential records with accuracy and purpose. In Part 1 of the Mastering Essential Records Course series, you will learn how to:

• Define what essential records are and recognise which documents are typically classified as essential in clinical trials.
• Understand the vital role these records play in ensuring trial integrity and regulatory compliance.
• Categorise essential records to know when and where each should be filed and updated.
• File and maintain essential records correctly within the Investigator Site File (ISF) and Trial Master File (TMF)

By the end of this course, you’ll be equipped to confidently manage essential records - strengthening both the quality and credibility of the trials you support.