For practices active in clinical trials, having policies on how to carry out and document the work a clinical trial involves can streamline operations and help ensure the trial sponsor is collecting valid data from the practice. This is where good Standard Operating Procedures, or SOPs, can have great value.
SOPs are not unique to clinical trials and research. In the military, the term “standing operating procedures” was first noted in the mid-20th century. Federal and state governments, large and small private businesses, universities and hospitals all use SOPs.
The purpose of site SOPs is to provide step-by-step instructions on how to complete a specific activity or task required for good practice. They are designed to ensure quality through standardization and increase efficiency, which in turn will improve performance and work quality. SOPs can also supplement training and provide a resource for new employees to self-answer their questions. Furthermore, following SOPs will help to ensure subject safety, regulatory compliance and data integrity.
SOPs and FDA Guidelines
Since the 1970s, the Food and Drug Administration (FDA) has regulated the conduct of clinical research trials. The Code of Federal Regulations (CFR) offers guidelines on how investigators should conduct clinical research. While they are guidelines, not specific rules or laws, the CRF guidelines are enforceable if the FDA finds that a clinical research site is not adhering to them. The most common and practical way to meet these guidelines is through the use of SOPs.
The International Council for Harmonisation defines SOPs as “detailed, written instructions to achieve uniformity of the performance of a specific function.”
Creating SOPs can be daunting, often adding more work for staff already bogged down by paperwork. However, they give guidance to the clinical research staff on many specific research activities that can range from how to complete specific forms, to more complicated issues in regard to principal investigator (PI) oversight.
The SOPs Format
SOPs, which a partnering agency can also write, should follow a specific format that includes:
• Title/policy number/issue date/implementation date/revision date(s), necessary to provide organization of the policies.
• Scope, which covers the area the SOPs address and to whom the SOPs apply.
• Policy, which covers the goal of the SOPs.
• Procedure, which may include applicable attachments, provides the specific details to achieve the policy within its scope. Attachments can consist of examples, forms or logs for conducting the SOP.
Frequently, SOPs will also cite the CFR guideline or other regulatory authority.
SOPs must also be reviewed annually to ensure they comply with updated industry standards, regulatory guidelines and current site processes. This review, and any necessary modifications, can be quite time consuming.
One drawback of SOPs is that an FDA audit can cite noncompliance if the practice doesn’t follow them as written. Conversely, the lack of SOPs may be more troublesome to the FDA than limited compliance to a specific one. Involving the clinical staff in writing SOPs may help reduce noncompliance by verifying they understand the procedures and that the procedures are valid in the real world.
Less Work on the Back End
While SOPs may demand more time and create more paperwork for your research staff on the front end, in the long-run their use can lead to less work on the back end, especially if your site experiences an audit by a sponsor, Institutional Review Board (IRB) or FDA.
Findings from an FDA audit can haunt a site for years because it puts into question the site’s ability to perform quality work. Though at the time of new study submissions, IRBs request information about a site’s five-year FDA audit history, sponsors can ask for the disclosure regardless of when it occurred.
At first glance SOPs appear to be one more layer of regulatory paperwork. However, when you consider their simple purpose—as written processes that enable a site to perform a task the same way each time—their importance is obvious. As with all good research, replication helps advance understanding. RS
Ms. Himmelman is a clinical research nurse at Retina Associates of Cleveland, Beachwood, Ohio. Ms. Weiss is clinical research coordinator and manager of clinical trials there.