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How to Write Clinical Research Trials SOP

Updated on July 30, 2011

Standard Operating Procedures called SOPs are generally prepared to explain a process that people should follow or the process followed by people. SOPs are important in most any job because it is a good idea to have procedures in place to prevent mishaps or confusion in how a process should be followed. For example, in clinical research, SOPs are developed to comply with the Code Federal Regulations. If you do not have SOPs to follow at your institution, you maybe putting yourself at risk for an audit. Questions will be asked as to how you justify your actions. Having poorly written SOPs can be just as taxing as having no SOPs. If you need to develop SOPs for your institution consider following some of these tips and ideas on what you may need SOPs for.

How to Write an SOP

There are a number of reasons why writing and developing standard operating procedures (SOPs) for clinical research is important.

  1. First you need to make sure you comply with the regulatory expectations to prevent any deviations or violations from the protocol.
  2. Second you need to ensure your corporate institutional policies are compliant with the expectations of the sponsor and protocol.
  3. Third, it allows for your clinical research team to have a reference of what is expected in their role and how to perform their job functions. Once you recognize the importance of SOPs you can begin writing them.

Standard Operating Procedures


Clinical research is performed in a multitude of settings, including academic universities, large institutional hospitals, and private practices. No matter where you work, you will find that SOPs are built off a foundation of ethical and scientific principal, the code of federal regulations, and institutional guidelines. Taking these into consideration will help govern how you develop your SOPs.

Create a List

Start by deciding what you need an SOP for. Decide on what you want your end result to be. If you have a solid foundation and you know where you want to go with your SOP it becomes easier to fill in all of the details. Make certain you meet the guidelines for your institution. For example, in clinical research SOPs are built off a foundation of ethical and scientific principal, the code of federal regulations, and institutional guidelines. Taking the guidelines into consideration will help govern how you develop your SOPs

List out all of the SOPs that are needed for your institution. Ideas might include temperature monitoring, site monitor visits, budget and contract negotiations, writing note to files, storage of clinical trial data, and organizing and filing papers. You may want to consider writing SOPs for job specific roles.

Map It Out

Draw a process map or flow sheet with one of the points on your list. How do you want to go from point A to point B? Go from one item to the next with flow. This will keep the process more structured and together.

Use Structure

  1. Purpose. What are you writing the document for?
  2. Scope. Who does the purpose apply too?
  3. Descriptions. What supplies are necessary?
  4. Requirements. What supplies are necessary?
  5. Responsibilities. Who is responsible or accountable for what actions?
  6. Forms. Make sure any forms are attached and referenced to.
  7. Procedures. Specify all of the details in this section.
  8. Definitions. Write out any terms that are needed to understand how to read the SOP
  9. Attachments and Appendices. Any additional forms should be attached.

Use the flow sheet you created and write in the specifics of each point. Your purpose will state what you are writing the document for. The scope should indicate whom the purpose applies. The descriptions, requirements, responsibilities, and procedures may include the specifics of the SOP and this section defines who is accountable for what actions. Any terms that are needed to understand how to read the SOP should be put in the definitions. Any documents or regulations that are specified in the SOP should be attached as a reference.

Read through your SOPs carefully to determine if they are readable by the average person. If you use regulatory terms be sure to include them in your SOP.

SOPs should be created with the intent of being followed without deviation. In an audit situation the SOPs will be examined.

In clinical research, use SOPs in conjunction with Good Clinical Practice Guidelines (GCP) to ensure that you comply with regulatory standards and human subject participation.

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      Jeremy Wilkerson, Omniavincit 6 years ago

      Good SOP's should not be taken lightly. There are so many different considerations under GCP, that you can spend lots of time writing the SOPs and still be out of compliance. A better option is to buy an in-expensive set of GCP compliant SOP's and then tailor them to your site and/or study. Here is a link to some more information on the importance of SOPs.