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Clinical trials require standard operating procedures (SOPs) to ensure consistency, quality and compliance.
Standard operating procedures are detailed documents that outline the processes, procedures and guidelines a clinical trial must follow. Trial personnel compile SOPs, and if required create new ones, during the initiation stage.
Clinical trials involve the use of multiple standard operating procedures, including those already written for the trial site or by the trial sponsor. If study personnel find that existing SOPs do not meet the requirements of the trial, they may initiate a review of existing SOPs or create new SOPs.
Once finalised, these documents provide a benchmark for various aspects of trial conduct and are adhered to throughout the trial lifecycle. They are standardised in line with national and international guidelines and ensure trials are conducted in compliance with regulatory requirements, industry standards, and best practices.
The typical scope for SOPs includes:
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