The Critical Nature of SOP’s
It is critical that every clinical research facility have SOPs or Standard Operating Procedures. An SOP is a document that clearly defines/describes how a procedure or process is performed at your research facility. Standardizing procedures and processes is key to collecting correct, timely, and consistent data which is a goal in every clinical research trial.
SOP’s for Training
SOPs are an excellent source for training permanent staff and temporary staff members how to conduct a procedure or process so the procedures or processes are consistently conducted regardless of who performs them. SOPs need to be as detailed as the process or procedure calls for to create consistent results. The documentation of training of your staff is critical so as to show external regulators and Sponsors that your staff does have the tools necessary to collect accurate and timely clinical research data in a consistent manner.
Mirror Process and Procedures
SOPs should mirror the process or procedure to ensure consistent data collection and documentation. SOPs should be created internally with staff participation and be specific to your facility so be wary of “buying” a set of SOPs. You are much better served by consulting an industry expert to help establish your SOPs. SOPs are critical to the success and prosperity of your clinical research site. Let us help you create an SOP “system” that will meet the expectations of Sponsors and the FDA. SOPs that are done correctly the first time will be a timeless asset to your organization.
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