Standard operating procedures: Don't wait until audit looms to develop SOPs
Seen as low priority, can actually lead to high quality
For many professionals in the clinical trial world, creating standard operating procedures (SOPs) is another box to check off. But if they look at it as a low priority duty, then they might be missing an opportunity to improve their organization's quality by using well prepared and regularly updated SOPs, experts say.
SOPs serve both as internal rules and an interpretation of federal regulations, says Janet F. Zimmerman, MS, RN, associate director of the clinical research group at Drexel University College of Medicine in Philadelphia, PA. Zimmerman has published papers on the importance of SOPs.
The Food and Drug Administration (FDA) does not require standard operating procedures for investigators and research sites, but they encourage and welcome them, Zimmerman says.
"It's not uncommon for academic sites and research practices and investigators to have them," she adds. "But they don't all have them."
Still, it is a good idea to have SOPs, especially for organizations that seek accreditation or that desire to do well during sponsor or regulatory inspections and audits.
CR professionals often put writing SOPs on the back burner until they are confronted with an audit.
"They understand that inspections people ask to see SOPs, and they think, 'Gosh, we don't have any,'" says Gayla Herschler, MSN, RNC, CCRP, a procedural nurse at interventional radiology at Scott & White Memorial Hospital in Temple, TX. Herschler has spoken about how to create SOPs at national conferences, including the recent SOP conference sponsored by the Society of Clinical Research Associates of Chalfont, PA. It was held May 7-8, 2009, in San Francisco, CA.
"So they ask one person to write them, and then they don't have the buy-in from staff because an SOP is just a piece of paper unless it's something people are going to follow," Herschler adds.
While typical, this approach is not ideal, Herschler notes.
"You need buy-in from management because writing SOPs will take time, and you need the right people on the committee to write them," she adds. "You especially need buy-in from the nay-sayers."
The best place to start is by creating an SOP for your standard operating procedures, both Herschler and Zimmerman suggest.
"If you have SOPs, you might want to have a document that explains those SOPs, and that's an SOP on the SOPs," Zimmerman says.
"The SOPs on SOPs should include who the SOPs apply to, who the author is, who the reviewer is, what the expectations are for compliance, the frequency of review, and those kinds of things," she explains. "It's like an introduction to your SOPs, and it's a good thing to have because it's the first SOP you'll read before you get into the SOPs."
The SOP committee should start with the procedures on SOPs, Herschler says.
"You sit down with a list of SOPs you want to develop and have the committee decide on a format for them," Herschler says.
Zimmerman recommends writing your overall procedures in a draft format, putting down what you want the SOPs to do and to whom they apply and then letting that serve as a guide.
"As you write separate SOPs, you should come back and revise the chief SOP and update it," she suggests.
"It's a plan, an outline," Zimmerman says. "Before you take a trip you need a roadmap of where you're going, so before writing SOPs, create an SOP that will help you have an understanding of who they apply to and what their purpose is."
The main procedures also should list consequences for noncompliance, she adds.
"I'd write that first, use it as my outline, and then eventually I'd finalize it as my SOP on SOPs," Zimmerman says.
Zimmerman and Herschler offer this advice for writing an SOP:
• Understand what the research enterprise is.
"What kind of affiliates, partners, and contractual obligations does the organization have," Zimmerman says. "If I were writing this SOP, I'd interview some key leaders so I would understand who is involved in this clinical research enterprise and what their relationships are."
Sometimes there are clear relationships, and sometimes the relationships are not clear," Zimmerman says. "They might be more political; they might be more of an affiliate or independent."
The key is to develop a clear sense of who will be required to follow the SOPs, what their vision is, and who are the key players to interview about the SOPs, she adds.
• Always interview more than one person.
"Sometimes, one person's vision and understanding may not be accurate or complete," Zimmerman says.
"In a lot of academic settings where research is being conducted, it's very complex because you may have physicians who are investigators," she says. "Also, there might be unpaid faculty and adjunct professors."
In the case of affiliates who are not considered employees of the organization, it might not be wise to say the SOPs are required.
It might be a better strategy to say the SOPs apply to all university employees, but are recommendations and guidelines for all affiliates, Zimmerman suggests.
"You might need legal counsel on the wordage," she notes.
• Carefully select an SOP committee.
Find someone with writing expertise and a couple of subject matter experts to be on the SOP committee.
"You need experts who know the process, and one of these people could be the project leader for the SOP," Zimmerman says. "You could have people on the committee who advise you on the legal aspects of writing the SOP."
The SOP committee should write the first draft. Then it should be circulated to several experts and a person at the senior management level, Zimmerman says.
"You want to make sure you're on the right track," she adds.
Writing the first draft often is a task added to committee members' other duties, so it should be assigned with a deadline to prevent procrastination.
"Keep it to a time table, putting deadlines in two to six week increments," Zimmerman says.
"You can't say, 'Write your first draft in two weeks,' so say, instead, 'Let's have the first draft written in four weeks,'" she suggests. "Then give them four to six weeks to review."
The key is to keep the process to within six weeks because people tend to lose focus, she adds.
Before the SOP is submitted for approval, it should be edited and changed, if necessary, Herschler suggests.
"You want it edited and formatted before it gets into the loop," Herschler says. "At our institution, we have the director of the department of research and the medical director go over it."
• Approve, review, and revise the SOPs.
Subject matter experts who know the research site's processes and a quality assurance manager should review the SOP.
"SOPs usually are dynamic," Zimmerman says. "You no sooner sign off on it then something changes; processes change, and this certainly is true in terms of quality improvement."
Reviewing SOPs is essential, or else an institution runs the risk of their being so outdated with current practices that clinical trials frequently fall out of compliance.
"When you write an SOP and put it on a shelf and don't go back and update it on a regular basis, then you could have a problem," Herschler says.
"There was one SOP that said staff would have to wear white uniforms, and nobody wears white uniforms anymore," she notes. "So you have to review these on a regular basis and update them."
The SOP of SOPs should state how frequently the SOPs will be reviewed and revised and by whom.
"A lot of organizations will review it every two years and some wait for three years," Zimmerman says. "It's a decision made by senior management."
The reason organizations might decide to not require annual reviews is because of the potential for noncompliance, she notes.
"If you say you'll do this every year and you don't do it, then you'll get dinged," Zimmerman says. "It really needs to be tailored to the organization in terms of risk management assessment and practicality."
Also, the review process should begin a few months before the existing SOP document expires to allow time for major changes and formal approval of these, she says.
"Arguably, it should be a smooth transition, so there's always an SOP in place," she adds.
The reviewer might be the person who was the project leader for the SOP.
"Assuming they're still there, they could take on that role again and bring together the same team," Zimmerman says. "Some organizations aren't big enough to have dedicated SOP individuals in their department or clinical group or quality group, so that leader of that department or group would have to stay on top of it as one of his or her responsibilities."
If any changes made are minor, then the new SOP is circulated to staff. If a proposed change is substantive, then the revised SOP would need to be formally reviewed and approved.
"You'd always have to have two people change it," Zimmerman says.
For many professionals in the clinical trial world, creating standard operating procedures (SOPs) is another box to check off. But if they look at it as a low priority duty, then they might be missing an opportunity to improve their organization's quality by using well prepared and regularly updated SOPs, experts say.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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