Business Featured

5 Steps to Creating an SOP

Image courtesy of Pixabay

The modern healthcare industry is complicated—and it can take a long time to learn the ropes, so it’s always good to have a system in place. SOPs, or standard operating procedures, are instructions that work as guidelines for employee work processes, such as for maintaining an Electronic Data Capture (EDC) system. These instructions can be used repeatedly and serve as a reminder of the best way to complete a task.

Think of an SOP like a recipe: It tells you how to make something, step by step—and all you have to do is follow the instructions and the dish will turn out perfectly every time. There’s no guesswork involved.

It’s important for healthcare professionals to have SOPs documented so that they’re easy to follow. It also makes the SOP easy to teach to new staff members and manage over time: if you want your SOPs to reflect the most current information, then all you need to do is update them.

What Is an SOP?

Standard Operating Procedure (SOP) is the standard that clinical trialists need to follow to ensure their trial is following the rules and regulations of their given organization. For clinical trialists, it is important to know what is expected of each step of the trial process. Applicable guidelines and regulations must be referenced, such as ICH E6 Good Clinical Practice and 21 CFR 50 for the protection of human subjects. Typically, an SOP contains the following elements:

  • Title page
  • Table of contents
  • Purpose (describe the clinical trial, summarize its main objectives, ensure all acronyms are defined at first use)
  • Procedures
  • Quality assurance/quality control
  • References

Creating an SOP

Here are the 5 steps for creating an SOP:

1. Make an Actionable Checklist

A checklist that is “actionable” means that each item on the list is a specific and concrete task that can be performed—nothing vague like “oversee project” or “monitor progress.”. Making your SOPs more efficient is as simple as designing them so they can be followed through by any clinical trialist. This will maximize the amount of work you are able to accomplish within a given timeframe, therefore being able to work more efficiently.

There are essential SOPs, and then there are optional SOPs. An example of essential ones could be how to obtain informed consent prior to starting a clinical trial. There is always going to be some kind of essential SOP that must be implemented before you start your trial, which means that having a checklist with those tasks first on the list (and marked as a priority) will allow you to comply with regulations in a timely manner.

2. Create a Plan for Reviewing and Updating the SOP

An important part of creating an efficient SOP is to have a plan for reviewing and updating it, so you don’t have to start from scratch every time. The key is to set up a system so that you can quickly identify what needs to be changed without having to review each step. If your team works from a template SOP, this process should be much easier because you can indicate when each section needs to be updated.

Adding a note for updating is an effective way of maintaining efficiency in your SOPs. If you have a team member working on the step, add their initials next to the comment so that they know to look over the section as well. This will ensure that no step is missed.

3. Collect Information to Include in Your SOP

SOPs are typically used to ensure uniform and quality output. This means that they focus on documentation of the steps, tools, and techniques used to complete a task or reach an objective. The most effective SOP template will be one that is tailored specifically to your company’s needs.

This means that the more information you collect regarding what you want to include in your SOP, the better you can tailor it to fit your needs. Collecting this information will not only help the development of your SOP but will also ensure that what you do finally put in your SOP is exactly what you want and need for day-to-day use.

The collected information should include:

  • What the procedure is and what it is for.
  • The people and departments that are responsible for completing the task or procedure.
  • Who requires training on this process, including who wrote it (if different from those required to complete the task).
  • When does it need to be done? How often?
  • What tools, equipment, and supplies must be available to complete the task?
  • Who is responsible for any reporting and record-keeping requirements?
  • Are there any environmental factors that need to be considered?

4. Write, Review and Publish Your SOP

Write your SOP, then have a team member review it. This will ensure that there are no mistakes or misunderstandings, which could cause an error in the compliant conduct of clinical trials. Once the SOP is reviewed and edited appropriately, have someone else read through it just to be sure before publishing it throughout your organization. This way you can feel confident that everything is correct before it is distributed.

5. Maintain SOP Overtime

SOPs are easy to use and effective, but only if they are kept up-to-date. Don’t let your SOP’s become stale because it could cause a number of issues including missed steps or lack of accountability. If you have the time, do a quick review every week just to make sure nothing has been added or if you have a team member who is responsible for the task at hand, then let them know that they are responsible for keeping the SOP up-to-date. If you want everyone to be responsible, then hold a short meeting each time a new employee is added to the project/task and go over the SOP together. Going through each step to make sure everyone understands their role will help keep everyone accountable and on track.

When you are responsible for tasks on your team, there is no way to avoid creating (or having assigned to you) SOPs. Whether or not someone has created an SOP yet, you can use the steps above to create one that will help your team. Implementing these five steps will also provide consistency in your project/task management, which will make your team more efficient and productive.

About the author


Deepak Behera

Deepak Behera is a physician-scientist turned executive, with expertise in clinical development and medical affairs across clinical, academic, and pharmaceutical/biotechnology sectors. He has over 12 years of experience in clinical research and related regulatory policies and submissions. Deepak’s goal is to push healthcare towards better patient outcomes, while at the same time generating value for all stakeholders. Democratizing clinical trials for patients and physicians aligns perfectly with this goal, and is why he founded Adaptive Research. In addition, Deepak provides strategic and operational advice to multiple pharmaceutical and biotechnology companies in the areas of clinical development, medical affairs, and technology assessment. He received his MD from MKCG Medical College at Berhampur University in India, and earned his board certification in nuclear medicine from India’s National Board of Examinations. He serves on committees and boards of various professional societies, including the Society of Nuclear Medicine and Molecular Imaging and the Indo-American Society of Nuclear Medicine. In his free time, Deepak likes to mentor young professionals, play volleyball, go for long drives and have fun with his two kids.