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12-May-2020 - 12-May-2020

J16 The Function, Importance and Writing of SOPs

  • Location:
    • Cedar Court
    • White Waltham
    • Maidenhead, Berkshire
    • SL6 3LW
    • England
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The Course

The most frequent reported deficiencies during inspections are the lack of written Standard Operating Procedures (SOPs) and/or the failure to adhere to them. Performing clinical trials is a complicated business, bound by regulations and good clinical practice, with the overriding concern of protecting the safety and welfare of study subjects. SOPs are critical tools in successful business operations for all those involved in doing clinical trials, including investigative sites, sponsors and IRBs. They are essential for standardizing processes, for ensuring that regulatory and organizational policy requirements are met, for training new personnel and for managing workload. This course will provide a practical insight into SOPs and equip participants with the knowledge and skills needed to write, manage and utilise SOPs within their organisations. Delegates will explore the principles of GCP and understand the need for, the function of and the importance of SOPs, the process of authorisation, training and implementation. The course will define the topics that require SOPs, explain the importance of flow diagrams and describe how to write and SOPs.   Learning Objectives   • Define an SOP • Describe the essential elements of an SOP • Explain why SOPs are required for Clinical Research • Identify when SOPs are needed and when they are not • Develop process maps • Understand inter-dependencies and importance of cross referencing   Course Outline   • GCP and the need for SOPs • The function of SOPs • Administration of SOPs  • Maintenance and version control mechanisms • Define SOPs required by department • Cross referencing of SOPs • Flow diagrams • Writing SOPs • Authorisation process • SOP Training • Electronic SOPs