Your standard operating procedures (SOPs) provide the framework for a well-controlled, compliant clinical trial.
These procedures are so fundamental, you may not have given them a second thought during busier times. Now, with many site activities stalled, your team members are looking for ways to stay productive. There’s no time like the present to revisit your SOPs to ensure they are up to date. Here are a few things to consider as you do.
What Are Standard Operating Procedures In Clinical Research?
Standard operating procedures (SOPs) are “detailed, written instructions to achieve uniformity of the performance of a specific function.” If these “instructions” or procedures are well-written, they should assist clinical research staff with running their clinical trial and with assuring compliance with Federal Regulations, Good Clinical Practice (GCP), and Institution Review Board (IRB) policies.
Your SOPs should be written in a way that supports these requirements, rather than replacing them.
Who Should Be Responsible For Creating SOPs?
Often department directors/leaders and a quality department work together to establish standard operating procedures and keep them up to date. The FDA Bioresearch Monitoring Guidance for Sponsors states that inspections are to “evaluate the sponsor’s/CRO’s/monitor’s practices and procedures to determine compliance with applicable regulations” and references the review of sponsor/CRO/monitor procedures as part of their assessment of compliance. For sites, however, the reference to procedures is more often directed toward the specific study protocol and the execution rather than site SOPs.
How Often Should You Review Your SOPs?
Standard operating procedures should be referenced routinely in daily operations to ensure consistency in project execution. However, that is often not the case. At IMARC Research, we recommend an annual review of SOPs to ensure the procedures still apply or whether any content requires updating. This review should be done by the SOP owners as well as an annual review by those who are instructed to follow the procedures. An immediate review and update may also be warranted if there are trends of noncompliance, an audit finding, and/or if an issue is reported by staff following the procedures.
What Should You Consider When Updating SOPs?
New technologies and new research methodologies raise new questions that standard operating procedures may not address. For instance, SOPs covering informed consent may need to be updated to address changes such as obtaining informed consent electronically.
If it has been awhile since you have updated your standard operating procedures, here are a few important questions to consider:
- Is the purpose and are the instructions of your SOP clear and concise (i.e. do some of the instructions allow too much room for interpretation)?
- If you are seeing noncompliance with SOPs, what language needs to be updated or removed (i.e. providing more defined timelines for deliverables)?
- Have there been any policy changes (i.e. updated regulatory requirements in a certain region)?
- Do the procedures work well together, or is there duplication among different procedures? Or maybe worse, are there conflicting requirements?
Where Can I Get Help With SOPs?
If you are still feeling stuck on how to establish or review your standard operating procedures, IMARC can help in a variety of ways, including:
- Conducting an audit of your SOPs, using current studies to assess compliance
- Performing a gap analysis of your SOPs to the appropriate regulations and providing detailed recommendations for updates or additions to make in order to achieve compliance
- Providing consulting assistance for any stage of your study to assist in SOP writing or updating
- Providing training on the Federal Regulation, GCP, and more to ensure your SOPs are on track and do not contradict required policies.
Although we know how eager you are for site activities to pick back up again (and we're right there with you!) you have a rare opportunity to slow down and revisit some of your foundational processes. This is also an opportunity to review standard operating procedures with your team so they stay sharp. Take advantage of it now, while you can!
Contact us to learn more about how we can help.