SOPs in Human Trials : Guidelines and Best Practices

Standard Operating Procedures (SOPs) are the staple of all good clinical research and ensure that protocols are carried out reliably and consistently from person-to-person. Once you've optimised your SOPs and carried out any necessary training at your site, tasks can go forward efficiently in line with any regulatory requirements or policies you might have in place.

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To create an SOP of exceptional quality, engaging with end users is a must and you might also find that co-developing your SOPs with all members of the team can highlight some unexpected and often helpful insights into your methods of working. Here are some of the most imporant points for best practices in developing new SOPs.

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Essential Activities : Make the List!

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Meeting with various members of the team and outlining critical activities is important. Make a list of the core features of the process. Here's an example. Let's say we are collecting blood as part of a site visit. Core parts of this process might be: (i) Get a suitable room/location; (ii) Meet with a participant; (iii) Collect blood; (iv) Process/dispatch blood/plasma; (v) Clear-up/prep for next visit. At this point we aren't particularly concerned with the technicalities of the process, just that the necessary outcomes can be achieved in a step-wise approach. Key points of best practice here are involving as many people as possible. Involve people with different skills and job roles who might be able to pad this out and provide novel ideas and suggestions. It is also important to review and make sure that everyone is happy to proceed.

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Make a Draft : Tasks and Responsibilities

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Who should be carrying out this SOP? Have an open forum with key staff (in person or online) and gather as many questions and points as you can under each of these key items we mentioned previously. Allow everyone to outline key tasks and responsibilities in creating your desired outcomes. This step might involve people at many level and it's important to give people the floor. Allow them to contribute anything they can think of - give everyone a voice in this session. Let's take one of the essential activities we used as an example to help guide us: "Get a suitable room". What are the necessary steps involved in making sure this runs smoothly? We might wonder where this room might be, if we have or need to reserve it. We might need some specifications of the room - is it up to regulatory standards? Can we work with biological fluids in this space? Does it have adequate space? A space for the practitioner and participant to sit comfortably? Perhaps an internet connection is required especially if an electronic data capture (EDC) system is in use. What might the training needs be for persons at each of these task levels?

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Disaster Plan

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The most important part in making things run smoothly is planning for the worst outcomes. Question what things might go wrong. There is no internet connection. The consumables or intervention have expired. The courier did not arrive in time to provision essential materials. The staff member required for the task is unwell or an unexpected absence has occured. Might these concerns bring about alterations in other SOPs? Possibly - and this is why this is a very important exercise.

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Step-by-Step : Grow a Detailed and Chronological List!

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You should now be getting a better picture of the SOP, and, how it interacts with other SOPs which are either in place already or ones that need creating. Chronology is the next most important step. What should happen first (either in this SOP or in related SOPs)? Go through the SOP in real-time with staff. Plan a fun interactive session - with role playing if necessary.

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Testing and Review

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Provide a draft of the finalised protocol for testing and allow staff to undertake this. This way the team can critically evaluate each point in the protocol. Why might this be important or different from a role-playing session? Perhaps when it comes down to practically undertaking the SOP, equipment setup and tasks take more time than anticipated. Maybe this will impact upon other steps in the protocol...

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Document Versions, Re-Review and Audit

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So you've finalised your SOP - what's next? It's important to version control documents - not just for good housekeeping, but for compliance to ICH-GCP. Many things might change in the foreseeable future so a good review every 6-12 months of your SOPs is important to ensure ongoing compliance!

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... Why should it all matter...?

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Having carefully planned SOPs in place can help everyone at every level. When everyone is on the same page, tasks can get completed confidently - and even junior or newly onboarded members of staff will have confidence in the protocol and it's outcomes. Here's how a great SOP can benefit your team:

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• Improve trust within your team
• Reduce costly mistakes
• Improve team confidence
• Disaster forecasting

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How will you be designing and maintaining your SOPs? Will you be using EDC? a CTMS? pen and paper? Let us know!

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