General Frequently Asked Questions

I was notified by the FDA that they are going to audit one of my industry-sponsored studies, what should I do?

First you should notify the study sponsor and inform them of the pending audit. The sponsor may want to send a quality assurance officer to your site to check that everything is in order before the FDA inspection. You can also request that OHSP conduct a quality review of the study. You should gather all the study documentation together, check to be sure it is complete (especially look for approval letters and consent forms) and put these in a place that is easily accessible.

A sponsor’s site monitor asked if we have Standard Operating Procedures (SOPs) during his monitoring visit. Is having SOPs a University requirement?

The University does not have a policy requiring SOPs for clinical research sites. Some sites develop SOPs for their research staff for specific study procedures, e.g., informed consent process. There are pros and cons on having site SOPs. They help to ensure that all research staff are conducting study procedures in a consist manner according to set standards. The downside of having formal, signed-off SOPs, is that monitors and auditors (including FDA auditors) will review your studies to ensure that you are following your SOPs in addition to the protocol and federal regulations. The research staff must be trained to follow the SOPs as written. SOPs must be updated as procedures change, which can require additional staff training.

Where can I find the form FDA 1572?

It can be found on the FDA website.