The Three C’s of SOPs
While Standard Operating Procedures (SOPs) are not technically required for clinical research sites, auditors, sponsors and CROs expect them to be in place. This expectation is so commonplace and the benefit of quality SOPs so great that it behooves any site to utilize them.
What considerations are there when writing quality SOPs?
1) Be clear.
Avoid vague language that will require interpretation. If it isn’t clear, the door to noncompliance is left open. Include step-by-step instructions and use lists or bullet-points that allow the reader to pause and process each step before moving on.
2) Be concise.
There is a correlation between SOP compliance and brevity. If it’s too long, people a) won’t read it all, or b) will miss important information. Keep the number of pages to a minimum, use common terminology and concentrate on the basic elements of the procedure to ensure consistency and compliance.
3) Collaboration helps.
Involve others at your site when drafting or revising SOPs. This will ensure a couple of things:
- The potential to miss important steps decreases;
- Communication and understanding increases;
- Those who were involved in writing the SOP will know exactly how to implement it.
If you are an SCRS member, send a message to the MySCRS Online Community requesting suggestions when creating or refining your site’s SOPs.
Disclaimer: This article and the SCRS website are public resources of general material and do not constitute legal or professional advice.