1) Collect a list of required activities
Start by collecting a list of activities that are required. Ask staff members who are involved with data collection to provide this list. This means that if your site has 2 to 3 people involved with data collection on any given study, ask them to write down steps that they typically accomplish with each study. Try to fill in the gaps and answer questions as they come up. The goal is to provide this SOP to anyone at your site, so they can clearly understand responsibilities and timelines. In the beginning, don’t be overly concerned about making the process more efficient or easier to follow. That piece will come down the road.
2) Write and review an initial plan with staff
It is important to stress that all people involved in doing the tasks and procedures should be involved in the writing and review of the initial SOP development plan. You may want to hold a meeting with staff members to critically evaluate and review tasks. This is the part where things can become interesting, especially when there are differing ideas about what is important and what tasks are not as critical. It’s important to remain impartial as a leader and reassure everyone that these types of issues are the basis for further development and evaluation of site SOPs. Acknowledge everyone’s ideas and feelings and never say, “You’re wrong!” This is simply a recipe for disaster for the team. However, it’s critical that you keep ideas moving and remind the group that out of respect for everyone’s time, you must move forward with new topics so that the group stays focused on the goal.
When drafting tasks and responsibilities, it can also be useful to write on a large sheet of paper (and don’t be afraid to use multiple pages if necessary). This helps everyone visualize different concepts and procedures, and then allows them to draw their own lines and connections between items.
The best way to wrap up the first meeting with your team is to set aside some time for brainstorming. This can help you to summarize and add additional steps. Individuals generally enjoy brainstorming and giving some extra time allows people to be more creative. While at the same time this approach doesn’t completely bore others that have a hard time with this phase.
3) Draft a detailed list of steps for the SOP
Once a handsome list of tasks is gathered, it needs to be organized into chronological steps. It can be advantageous to hold another meeting with the group once this is finished. But before you meet again with the group, ensure that the secondary steps are listed as a process flow chart. Add a few sticky notes for tasks that could be rearranged, so that others might be able to easily move items.
4) Begin testing among the group
Once the final list of steps is reviewed by the group, provide copies to the team and start testing. This allows the group to critically evaluate the SOP by using the steps listed. Does it work? Add any missing items and facilitate a discussion about redundant or unnecessary steps that could be eliminated. In order to wrap up the activities of SOP writing, it is typically necessary to introduce the concept of a “guideline” to the group. What is a guideline and does it differ from an SOP? Read on to learn more.