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Inspection Q&A with Dr. Chrissy Cochran, FDA, Director of Bioresearch Monitoring Operations

At last week’s Society of Quality Assurance Annual Meeting, I had the opportunity to interview Dr. Chrissy Cochran, Director of the Office of Bioresearch Monitoring Operations (OBIMO) at the US Food and Drug Administration. The BIMO organization is tasked with performing on-site inspections and data audits to assure data quality and integrity and protect subject rights and safety related to FDA-regulated research across FDA’s six centers. Following is a Q&A with Dr. Cochran touching on topics frequently raised by sponsors, CROs, and clinical sites.

Q:  How do FDA investigators typically handle pre-inspection requests?  How do you prefer to receive documents before an inspection starts?

A:  FDA investigators will call to pre-announce the inspection.  The inspection starts when we issue the Form FDA-482 on site.  OBIMO investigators do not request any documents before the inspection starts.

Q:  Do you foresee FDA investigators taking more advantage of processes to access sponsor Trial Master Files (TMFs) directly?  TMFs can be difficult to navigate – would FDA investigators prefer to look through a TMF independently, or do they prefer to request specific documents?

A:  Investigations Operations Manual (IOM) Chapter 5.10 lays out the process for our staff to request read-only access to a sponsor’s systems.  The sponsor has the option to agree to the access or not.  If the sponsor is not comfortable with providing the investigator access, for example the system is difficult to navigate, then we would expect that a staff member be available to navigate while the investigator describes what they would like to look at in the system.  There should also be an ability to print specific documents, either in paper or to a PDF to provide to the investigator, if requested.

Q:  We have heard that FDA prefers to receive electronic documents during inspections via Box.  Is that FDA’s policy, or are there alternative methods for receiving documents?

A:  Many of our investigators have Box accounts.  This allows them to collect documents electronically and have less paper to carry around.  We also accept documents via paper or thumb drive.

Q:  Sponsor staff are frequently very nervous about being interviewed during inspections.  How much weight do you give to comments that are made by interviewees?

A:  We understand that many staff are nervous when they talk to the investigator.  We weigh what is said along with the information that we see.  How much weight is put on any one interview will depend on the inspection.

Q:  Per FDA’s inspection data, there are very few findings related to 21 CFR Part 11.  Could you comment on FDA’s focus?

A:  FDA is using enforcement discretion with respect to Part 11.  If there are issues with Part 11, we would cite back to the predicate rule and the issue the lack of being Part 11 compliant is causing.

Q:  With the pandemic we’ve seen an increased use in vendors who are contracted by the sponsor but are performing work on behalf of the clinical investigational site – for example, a mobile vision clinic, or telehealth provider, or even a data entry clerk to help with a backlog.  Which BIMO manual(s) would you use to inspect these vendors?

A:  This is a bit complicated.  We would need to look at the protocol, which should describe the vendors and services that are being provided.  The work the vendors are doing is on behalf of the clinical investigator, but they are hired by the sponsor.  Therefore, the sponsor has the responsibility to ensure they are qualified to conduct the study.  The selection and monitoring of the vendors would be inspected under the sponsor compliance program, but the clinical work of the vendor would be inspected under the clinical investigator compliance program.

Q:  What would you like sponsors and CROs to know about inspections?

A:  When we show up, we’re there to do a job.  Please treat us as people!  We’re not all scary.  To ensure you are ready for an inspection, there are a few things that anyone can do: ensure documents, systems, and files are inspection ready as the trial is progressing; read the IOM (Chapter 5 for inspections and Chapter 4 for sampling (bioequivalence studies)), the compliance program for sponsors and CROs; and ensure everyone is familiar with the regulations and how they relate to their role.

 

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