SOP to you drop: Process inclusion and education
Write clear, concise and practical SOPs
The first step to obtaining staff buy-in for your standard operating procedures (SOPs) is to include staff in the process of writing the SOPs and to make sure the final document is clear, concise, and useful.
"We often paint ourselves into corners," says Gayla Herschler, MSN, RNC, CCRP, a procedural nurse at interventional radiology at Scott & White Memorial Hospital in Temple, TX.
"You have to be sure people will use the SOPs," Herschler notes.
Any SOP that is 10 pages or longer is probably not going to be a popular read by staff, she says.
"We like the SOPs' short and sweet, clear, concise, and cogent," Herschler says.
"If the SOPs are too wordy and say too much or are too long, nobody wants to read them," she explains. "Or they might not be clear enough or so pie in the sky that they're absolutely suggesting something that nobody wants to do."
A two-page SOP might be too short, so an optimal length could be three to six pages, suggests Janet F. Zimmerman, MS, RN, associate director of the clinical research group at Drexel University College of Medicine in Philadelphia, PA.
"It depends on how complex the organization is that the SOPs are being written for," Zimmerman says.
Also, an SOP might address a common research practice, but is worded in such a way that it excludes variations from this practice.
For example, if someone writes an SOP that assumes researchers will conduct a physical exam of each subject, then there will be a problem for investigators of studies where a physical exam is not necessary, Herschler says.
"Then if you have someone who does a study that doesn't have a physical exam, then the investigator is out of compliance because he/she didn't follow what was written in the SOPs," she explains.
SOPs should have a quality component that helps assure that everyone is following the institution's rules consistently, Zimmerman says.
But there should be both some specificity and some flexibility in how the rules are stated. This is to ensure the SOPs will apply to all clinical trials conducted at an institution.
"You could end up with an SOP that is so broad and nonspecific that it really is not helpful," Zimmerman says.
On the other hand, the SOP should not be too detailed.
"If the SOPs are too specific you can't extrapolate them to all situations," Herschler says.
Accountability without obstacles
The key is to strike a balance between demanding some accountability and creating too many obstacles for successful compliance in a variety of situations.
Another way to obtain staff buy-in is to make certain the SOP-writing committee represents all interested parties and has members who will create some enthusiasm and acceptance of the final product.
"Hopefully, the people you selected to write and review SOPs are close enough to the process that there will be consent and consensus support when the SOP is approved," Zimmerman says.
It also helps to send SOP committee members to seminars and workshops on how to write SOPs, Herschler suggests.
"Each group at an SOP seminar will write an SOP while they're there, and then when they leave they know they can do this," she adds.
Once the SOPs are written, it is crucial to provide adequate training and education.
"If you just write the SOP and don't train people, then it's not worth the paper it's written on," Herschler says.
"Usually when an SOP is ready to be finalized and signed by senior management, there is a 30-day window, which is a short window, when the personnel who this SOP applies to are informed and trained on the SOP," Zimmerman says. "The trend now is to not release your SOP and then notify and train people, but to do this before the SOP becomes effective."
Part of the training should focus on why it is important for clinical research institutions to have their own SOPs.
"I think you should lay the groundwork that people are asking for these, that sponsors want them, monitors want them, and it's not just a piece of paper," Herschler explains. "The whole purpose of research and of SOPs is that what we're doing is for the betterment of humans and the protection of human subjects."
Following SOPs is not just for keeping in compliance, it is so an organization will be doing its research the right way, she says.
"So when we're making an SOP, we want to do everything we can to make the process as perfect as possible for the protection of human subjects," Herschler says. "This will help improve the quality of research, and it's why you need buy-in from management too."
Managers should attempt to understand their issues and knowledge about SOPs.
"Listen to their concerns and experiences," Zimmerman says. "Then put a positive spin on why you're doing this."
For instance, managers could ask their staff, "Wouldn't you like some guidelines or clear direction on how to do these things?"
Staff SOP training should be conducted with a variety of educational methods, including role-playing.
"Role-playing is great when we're discussing how to conduct informed consent," Herschler says. "The training would vary with the message, and the time spent on it is tailored according to your population and staff and their experience and preferred learning methods."
Some research organizations will not have the time and resources to provide SOP education and training, so they will need to use SOP compliance documentation to show that each employee has read the document.
"Some organizations have on their SOP compliance documentation a statement that says, 'I have read and agree to comply with everything in this SOP,' and then they sign and date it," Zimmerman says. "This puts the responsibility on the employee."
Whichever way an organization provides education about its SOPs, it should note this method in its SOP on SOPs. The overall SOP needs to note how compliance is verified, Zimmerman adds.
This way, if an organization is audited by the Food and Drug Administration or another entity, there is documentation that explains what type of training and education they provide and why they do it this way, Zimmerman says.
"If the FDA auditor comes by and asks about training, you read the SOP on SOPs that says, 'Because of limited resources the employees are required to read and comply with the SOPs,'" she adds.
The first step to obtaining staff buy-in for your standard operating procedures (SOPs) is to include staff in the process of writing the SOPs and to make sure the final document is clear, concise, and useful.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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