by Barb Duerr, Principal Project Manager and Mary Kay Sobcinski, Senior Principal Advisor
Have you ever been through an FDA inspection? You may be lucky if you can answer no, but you are experienced if your answer to this question is yes!
FDA’s Bioresearch Monitoring (BIMO) program is designed to protect the rights, safety, and welfare of subjects. It also verifies the accuracy and reliability of clinical study data and assesses compliance to FDA regulations. Undergoing an FDA inspection can be an excellent educational and professional development opportunity for a study coordinator, but it can also be panic inducing when you receive the call that FDA is coming to inspect your site. BIMO inspections can be conducted by FDA at any time during a clinical study, either “for cause,” near the time of study closure, or during agency review of a marketing application. In most cases, however, the inspection occurs prior to or near the time of study completion.
BIMO Case Study
A sponsor submitted a premarket approval application (PMA) with data from a study that had been completed more than five years prior. One of the sites had archived all of their study files offsite, the study coordinator had moved to a different company, and only the principal investigator (PI) remained from the site’s original study team. Picture that you are the current study coordinator for that site: you never worked on the study and neither you nor the PI has ever undergone an FDA inspection. But, you’ve been designated to not only participate in the inspection, but also to be the front person for the FDA’s inquiry. You have a lot of questions and concerns: “What is a BIMO inspection?” “How do I support a BIMO inspection?” “How do I do it for a study that I’ve never worked on?” “What resources are there to help me?” “What do I do when I can’t answer an FDA question?”
The Role of the Sponsor
- helped answer these questions and prepare the site for inspection, the sponsor notified the site of the PMA application,
- offered individualized, proactive training to refresh the site on the study,
- and, offered to provide on-site, in-person inspection support by the study’s CRO.
The Role of the CRO
RCRI played a critical role in preparing the site for inspection. We:
- conducted an intensive BIMO inspection training via webinar to ensure all involved site personnel were refreshed on the study and site’s role in it, that they were comfortable with the inspection process, and that they could answer FDA’s questions honestly and confidently,
- provided training for proper inspection conduct with the site and how to interact collaboratively and effectively with FDA,
- trained the PI specifically on what to expect during the inspection and refreshed his memory about the study and his site’s results, adverse events, and protocol deviations,
- and, worked with the PI and site coordinator on retrieving, reviewing, and organizing the study documents that had been archived for several years.
Several days before the inspection, RCRI personnel flew to the site and assisted the study coordinator with unpacking and reviewing the study files to ensure they were in good order and to familiarize her with the study history and file structure. During the inspection, RCRI staff were on hand and assisted the PI and study coordinator with locating documents requested by the inspector, logging the requested documents on the audit log, taking notes, and supporting their responses to FDA questions.
The PI and study coordinator were in charge of the inspection, but the RCRI’s support as the sponsor representative was invaluable to ensure the inspection proceeded satisfactorily from both the site’s and FDA’s perspectives.
What Was Learned
In this case study, the sponsor played a critical role in ensuring the site under inspection had access to the right resources, but RCRI also played an invaluable role in the actual preparation and inspection.
The site PI and study coordinator thanked RCRI for providing help and guidance before and throughout the inspection process. They both especially appreciated discussions regarding how they could apply what they learned to future studies and essentially be “audit ready” at all times.
The FDA inspector also expressed her appreciation of RCRI’s support. Both during and after the inspection, she acknowledged the challenges for a site to be inspected by FDA under more typical circumstances, such as during a study or immediately after closure, but also commented on the unique burden placed upon the site during the inspection of the long-closed study. She stated that FDA recognizes sponsor/CRO support is very helpful to both the site and FDA in reducing that burden.
Sponsor and CRO assistance during a BIMO inspection helps to ensure that site personnel are well-supported by the sponsor and are able to act with confidence, ultimately contributing to a successful BIMO inspection with no findings and no issuance of a Form 483. While some sites don’t allow sponsors to be present during an inspection, in-person sponsor/CRO presence can be especially helpful to site personnel for studies of long duration, with high degree of complexity, and for those studies that closed more than a few months before FDA’s visit.
If you have questions about an upcoming BIMO inspection, get advice from experienced research personnel. Contact Samantha Thrun at email@example.com or 952-224-2260.