Data Collection in Clinical Trials: 4 Steps for Creating an SOP

Anders Lindquist
Independent Clinical Research Consultant
October 14th, 2013

A standard operating procedure (SOP) simply and clearly describes how a particular task is to be performed by staff at an organization. When tasks are performed consistently, it allows personnel to be more efficient and productive. In the context of properly maintaining an electronic data capture (EDC) system, standard operating procedures (SOPs) are essential to ensuring that regulatory and organizational policies are met. Training for new staff and workload distribution activities are also enhanced by SOPs.

Furthermore, sponsors and other affiliate clients are typically impressed when questions of site performance and processes are addressed in standard operating procedures. However, the actual task of writing an SOP is not easy. The best examples are simple to read and allow staff to quickly understand how their specific role contributes to the team. So what is the best approach for creating an SOP? The best approach involves developing a plan with all staff members that are involved with data collection at your institution, and defining the relevant roles and responsibilities. This article will look one recommended approach for creating an SOP.

Related article: Practices for eCRF Design: Defining Roles and Responsibilities

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.

Watch our free, on-demand webinar to learn different methods of data collection in clinical studies and how they compare to an EDC system.

Additional Considerations for SOP Creation:

Separate guidelines and SOPs

Guidelines are detailed descriptions of the processes and further explain activities within the organization. An SOP generally does not need to be updated frequently, whereas guidelines might need more frequent updates. Having two separate categories allows the group to focus on global issues separate from local or smaller details that might need to be changed due to other policies. An advantage to separating out these documents is that it allows smaller teams to provide much greater details on activities. Another advantage is that if there are changes to an application or a program update, the SOP can typically remain unchanged, but the specific details of the tasks listed in the guidelines are updated accordingly.

Consider generally accepted SOPs for data collection

Overall there are two main SOPs for this topic that are generally used and that cover all aspects of data collection. These are “Correcting CRFs and source document errors” and “Handling of case report forms (CRFs).” The corresponding guideline documents should go into further details on roles and responsibilities while ensuring that all activities have corresponding assignments to individual team members.

Don’t be afraid to start from scratch 

Oftentimes it is difficult to see the accurate picture of how tasks should be completed unless you avoid looking at the old template. The previously created documents might not reflect current company culture and if the goal is to create a fresh and clean approach, then starting from a blank document is useful. It’s not like recreating the wheel, it’s avoiding using old paradigms.

Don’t confuse SOP creation and compliance with 21 CFR Part 11 

While compliance with 21 CFR Part 11 is important to consider while developing an SOP, there are many requirements associated with the regulation that go beyond the scope of creating an SOP for data collection. 

Learn how Forte EDC ensures data security and integrity using audit trails and secure signatures to fully support validation and compliance with 21 CFR Part 11. Download the overview, or follow the link below.

Data Management EDC

5 Comments

5 thoughts on “Data Collection in Clinical Trials: 4 Steps for Creating an SOP

  1. Another important SOP not mentioned here that is involved with data collection would be ‘Database Build and Maintenance’ for use of EDC systems and not just paper CRFs.

    I have been involved in my organization developing SOPs and lower level documents in the past and agree SOPs should be high level. Unfortunately, not everyone in my organization agrees, but maintenance through a Documentum system will change their viewpoints for sure, not to mention internal and external QA audits as well as audits by the FDA.

  2. I would like to start my career as a Clinical research data coordinator, so what will my roles and responsibilities be and what knowledge is required to start this job?

    1. Hi Shilpa,

      You posed a very good question, so good that we decided to write a blog article about it! Our Director of Data Analytics, Wendy Tate, will write a short article about the skills/education needed for the complex role of clinical research data coordinator. Keep a look out for the article to post on our blog over the next couple weeks.

      Thanks for the great comment!

      -April

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