Show SOPs Respect to Improve Clinical Trial Results

Edye T. Edens, JD, MA, CIP, CCRP, Senior Research Compliance Consultant, First Class Solutions, Inc.

To paraphrase comedian Rodney Dangerfield, standard operating procedures (SOPs) don’t get any respect. They can be tedious and time-consuming to develop, and tough to implement and maintain. Plus, they’re usually not a priority unless a regulator shows up in the waiting room.

“We know they’re important,” says Edye T. Edens, JD, MA, CIP, CCRP, senior research compliance consultant at First Class Solutions, Inc. “We just need to know how to do them.”

Luckily, Edens has some proven tips, tools, and tactics to help even the wariest clinical trial professional get a handle on their all-important SOPs. It begins at the beginning, she says.

Stymied by an imposing blank sheet of paper? “Just start typing,” Edens says. “If you are blinking and staring at the screen, waiting for the perfect words, you’re going to be there a long time.” Instead, just dive in, get started, and celebrate your accomplishment, Edens says, because “50% of the battle is just getting started.”

Of course, it’s about more than making a few strokes on the keyboard. Edens notes there are many resources available in the public domain that provide the basic skeleton for SOP documents. “You don’t have to reinvent the wheel,” she says, noting that many people in industry are more than willing to help and even offer up their own often-transferable SOPs. “Ask for help and take ideas from other people,” Edens says.

Writing Effective SOPs: A Step-by-Step Informational Session

Join Edens at the ACRP 2020 annual conference in Seattle, May 1-4, to learn the core principals of writing effective SOPs. In addition to providing a step-by-step analysis of the importance of effective SOPs, Edens will address tedious details and global models to leave participants with a toolkit they can easily take home and operationalize at their organizations.

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If getting SOPs off the ground is one big challenge, the other big ones is keeping them updated, Edens notes. “You might have someone enthusiastic about one for a time, or a reaction to a regulator” that sparks an update, only to see the SOP subsequently lay fallow and gather dust in the months and years ahead, she says.

Be proactive and prioritize the updating of SOPs. In many cases, necessary updates will be few and far between, and not all that difficult to attain, either. “Make SOP revision part of an already existing management meeting, and identify the [usually few] that need updates at any given time,” Edens says.

“Keep it bite-sized” by setting out a realistic timetable a year ahead, she advises. “That’s the trick—it won’t be time-consuming” if you corral the process, she adds.

Finally, take a good look at your own personnel. Help may be closer than you think, especially if you don’t limit yourself to the upper echelons of the company’s organizational chart, Edens says. “You may have someone on your team who happens” to like doing SOPs or otherwise has an interest in them, she notes. In some cases, they may simply be a good writer or editor as opposed to a subject matter expert.

Further, don’t dismiss an enthusiastic junior team member out of hand, Edens advises. “You may have a potential star who’s looking for a new challenge and a way to prove themselves,” she says. Bringing them in to help on SOPs can be a way to galvanize the entire project as you groom up-and-coming talent.

Author: Michael Causey