Standard operating procedures (SOPs) are the foundation for any effective clinical research program, experts agree. The U.S. Food and Drug Administration (FDA) agrees, too. It’s one of the most common areas the agency scrutinizes during an inspection. Officially, SOPs are defined by the International Conference on Harmonization (ICH) in its Good Clinical Practice Guidelines (ICH GCP E6) as “detailed, written instructions to achieve uniformity of the performance of a specific function.” Unofficially, it’s not always that simple.
While SOPs have been generally considered the purview of sponsors and CROs, they’re also important for institutional review boards/ethics committees (IRBs/ECs) and Investigators. Sponsors and CROs face distinct regulated tasks and requirements. Some good news: Solid SOPs can help minimize the challenges presented by staff turnover i.e. inconsistent data collection and reporting techniques. Research relies on repeatable, reliable, accurate data, a breach or compromise in any of those can be catastrophic to the entire clinical research study which can ultimately lead to a rejected product, or worse: approval of a product without fully reported safety information. With strong documents in place, it’s that much easier to bring a new employee up to speed and prevent any problematic operating gaps.
For example, it is critical to have SOPs in place to address document control and informed consent signatures, says independent research consultant Janet Holwell. It’s easy, especially for a new employee, to overlook the requirement to have the subject and the investigator sign the consent form simultaneously. While it’s often an honest mistake, FDA won’t always be forgiving. She also stresses the need for SOPs addressing version control. Headers and footers, and even versions of forms on different color paper, can be part of an SOP that will help guide new and long-time employees, she says.
Grappling with SOPs can be a daunting task. Which SOPs are required and how they should be written is open to interpretation. Standard templates and standard SOP topics can help get the ball rolling.
Which SOPs are Required of Sponsors/CROs, IRBs/ECs, and Investigators?
Three common SOP topics that are applicable industry-wide to Sponsors/CROs, IRBs/ECs and Investigators include staff training, safety monitoring, and protection of human subjects to name a few. The scope of each will differ since each entity has different roles to play in the process of a clinical trial.
More specifically, investigative sites should have additional SOPs in place to support the work performed by site personnel and ensure that the Investigator responsibilities detailed in ICH GCP and Federal Regulations are upheld. Additional examples include:
- Handling of essential documents
- Investigational product management
- Informed consent process
- Inspections by regulatory authorities
How Should SOPs be Written?
SOPs should not merely be a duplication of regulations or guidelines. Rather, they should be instructive to explain how the regulations and guidelines will be followed in a consistent manner. There’s a fine balancing act required between being too flexible and too rigid. On the one hand, it is rather pointless to have a very general procedure that does not explain who is responsible for what specific task and when. But on the other hand, if the procedure is written too strictly, it leads to risks of SOP deviations which is probably worse than not having an SOP in the first place.
A good SOP should clearly identify the scope, be separated into easily identifiable sections, include responsibilities for specific tasks, detailed procedures to perform tasks, and any associated documents/forms/tools to support the work governed by the SOP such as checklists and templates.
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These resources are from ACRP’s eLearning course, Site Quality Management Tools: SOPs, Metrics, and Training, available for $99 to ACRP Members ($149 for Nonmembers).