Frequently Asked Questions:

Q:  What is an SOP?
A: A standard operating procedure (SOP) defines the processes and procedures within your research area.  They define how employees perform their day-to-day job duties.  SOPs are also known as “practices” and “work instructions.”
   
Q: Are SOPs required?

A:

 SOPs for clinical research are required by regulations.  They are usually the first items reviewed in a regulatory inspection and an excellent source of documentation.  They clearly identify the roles and responsibilities of research team members, provide standard instructions, and improve efficiency.  However, MCG does not require the use of these SOPs but they are recommended.
   
Q: Can we modify the SOPs to fit our research area?
A: Research areas are encouraged to use the universal Clinical Research SOPs as a template and adapt them to their specific area(s) and processes.     
   
Q: We would like to modify the SOPs to fit the processes of our research area.  However, we are confused about how to do it.
A: The OHRP Training Coordinator is available to meet with research teams to discuss methods of modifying SOPs to fit the processes of your research area. 
   
Q: How should we retain SOPs?
A:

The Clinical Research SOPs developed by the Clinical Research SOP Workgroup will be stored and archived on the OHRP website.  However, if your   research area modifies the SOP it is your responsibility to develop a retention system.

   
Q: How should we document that everyone in our research area has read the SOPs?
A: Each member of the research team should receive training on the SOPs.  This can be accomplished using various methods:

1) Organizing a formal meeting to discuss the SOPs and how they apply to your research area.  Each member attending should sign a document stating indicating their attendance and willingness to comply with the procedures detailed in the SOP.

2) Storing modified SOPs on a common network drive and requiring each research team member to read the SOP and sign a statement indicating that they read the SOP and their willingness to comply with the procedures detailed in the SOP.
   
 

Tips for Modification and Implementation
of Clinical Research SOPs:

  • Develop an internal review and approval process
  • Choose to store SOPs electronically or on paper.  If you choose to use paper as your primary storage medium, consider the following: 
    • A maintenance plan should be developed to ensure the correct version of the SOP is being used.
    • Ensure that all members of the research team have access to the SOPs
    • Develop a system of archiving obsolete SOPs
  • Develop a process of periodic review even if there were no needed changes in the interim.
  • Establish a consistent procedure for communicating the final version of the SOP to all affected personnel.
  • Establish a process for addressing issues that may need a SOP as they arise.

 

 

 

 

Revised November 12, 2008.   Please send comments, suggestions or questions about this page to Angela Randazzo, ohrp@mcg.edu .