How to Write SOPs Using the FDA Guidance Document

The U.S. Department of Health and Human Services Food and Drug Administration developed a procedural document Finalized October 2009 titled “Guidance for Industry -Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects,” Click on the link below to access the guidance document. Use this document to help you understand the scope of the investigator’s responsibilities and ideas on what standard operating procedures should be implemented at your site.

Investigator Responsibilities

The guidance document should be used with the goal of helping investigators. The principal investigator of a clinical study has responsibilities to abide by when conducting a clinical trial investigation.

Responsibilities include:

• protecting human subjects
• following the protocol
• ensuring integrity in the data

The document provides an overview and recommendations for investigator responsibilities including delegation of duties to staff, training staff, supervising staff, and oversight of the study. Red flags appear when the studies become too cumbersome for inexperienced staff that enrolls a large number of subjects.

SOPs

Standard Operating Procedures (SOPs) are a set of procedures that are used to improve the process for operations. Although the guidance document does not directly state what operating procedures are necessary, there is a list for a plan that should include procedures to be implemented.

Examples listed in the document include “A procedure for ensuring that source data are accurate” and “A procedure for dealing with data queries and discrepancies identified by the study monitor.” These are merely procedural recommendations.

If the SOPs for your site are in development then use the guidance document as a tool.

Include SOPs on:

• Training staff on the job and the protocol
• Informed consent process
• Recording source data and handling source data
• Dealing with discrepancies
• Following Good Clinical Practices (GCP) guidelines

It is the investigator’s responsibility to ensure that staffs comply with the protocol and adverse event reporting requirements. Review all of the procedure recommendations in the document to determine which ones you could use when developing SOPs.

Many sites have institutional SOPs that will apply to the procedural recommendations.