Everyone understands how important quality control is to clinical trials. Without standard operating procedures, researchers cannot ensure site staff perform tasks consistently—or even correctly. And yet, The Global Journal for Clinical Research Sites states that it’s common for sites to not document their internal quality control practices or SOPs.
Sites overlook this step for many reasons, including a lack of resources and time. Staff members don’t just record all processes; they also have to audit and maintain these processes. But documented quality control procedures and SOPs protect a study’s patients and its data. They also can help sites in some unexpected way; if your site is light on documentation, consider the following benefits:
Sites lacking documented quality control processes likely rely on internal knowledge for training purposes. But if your current employees are already too busy to write down procedures, will they have time to train coworkers? Don’t create an extra drain on resources by relying on them to teach your site’s specific protocols, devices, computer systems, and more.
Technological options allow sites to train new employees online. This makes onboarding new employees more efficient. However, the processes won’t be better without documented SOPs for leverage. Design training with these SOPs in mind can ensure new staff members immediately know the right way to handle key responsibilities.
SOPs help staff understand how to handle simple, day-to-day tasks, like counting pills. But they also set you up for success for less common issues. For instance, is your site prepared in the event of a disaster? What about if you suspect fraudulent behavior? Again, the hope is that you never have to deal with such issues, but if you do, you’ll have a plan in place.
SOPs also provide structure for writing and naming documents. You don’t want a situation in which you can’t find a patient’s information because it’s misfiled or mislabeled. And you definitely don’t want this to happen when a monitor shows up—and questions you as a result. That can make your site look bad and hurt your relationship with that sponsor.
Sites compete for business based on many factors, such as their capabilities, enrollment data, and screen failure results. Once you’ve proved proficient in those areas, you’ll need a different way to set yourself apart. The answer? A robust set of quality control procedures and SOPs.
Your site’s compliance with GCP, ALCOA, and other regulations is a given. But you can show sponsors how far above and beyond you go to produce the best results. For instance, what if you have a documented checklist covering informed consent, medical form releases, and every other step in your quality control process. That will show you take compliance and a sponsor’s business seriously.
CTMS Organizes It All
If you remain wary about documenting internal quality control procedures and SOPs, it may be because of the where, not the what—as in where will you keep all these items. A clinical trial management system (CTMS) can organize your documentation and let you share it across multiple departments and sites.
Want to learn more about how a CTMS can help your site? Request a free demo of Clinical Conductor today.