06/18/2024

On June 5th 2024, the US Food and Drug Administration (FDA) released a draft guidance for industry on the processes and practices that apply during an FDA Bioresearch Monitoring (BIMO) inspection in compliance with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA). The BIMO program ensures the quality and integrity of data being submitted for FDA regulated research via inspections, data audits, and remote regulatory assessments (RRA) to uphold and protect the rights and safety of research participants. The draft guidance incorporates concepts from the BIMO Compliance Program Manuals (CPGM) used by FDA field investigators to guide a regulatory inspection. The draft guidance brings together concepts the FDA has presented at conferences and the current regulatory environment, such as immediate FDA access to electronic systems upon request during an inspection and the standard use of remote assessments. It clarifies that requests for records could be in advance of inspections or could replace an onsite inspection. It also clarifies whom and what could be inspected.

Per the FDORA requirements the guidance includes:

Types of records and information required during an inspection.
- Typically, inspectors will ask for all the records and information related to the study conduct, analyses, and results, including but not limited to:
  - Investigator Brochures
  - Informed Consent Forms
  - Delegation logs
  - Investigation product shipment and storage logs
  - Training records
- These can be paper copies or electronic for which the site should be prepared to give inspectors full read-only access to the systems storing them.
Best practices for communication between the FDA and industry before, during, and after an inspection.
- The guide covers:
  - The Pre-announcement Notice: this may include (however not required) the scope of the inspection, the intended duration, as well as what records the inspector will be looking for.
  - Communication During Inspection: this includes questions that may be asked to the establishment’s staff, as well as the time and manner that staff should respond.
  - Communications After Inspection: this section highlights the importance of responding to any issuance of a Form FDA 483, “Inspectional Observations”, which are given to an establishment’s management to notify them that the investigation found objectionable conditions and practices during their inspection. Depending on how the establishment chooses to respond to the 483 could dictate whether the FDA takes further regulatory action.
Other inspection-based conduct.

While there is nothing novel about the rules and regulations within the guidance, it provides a comprehensive outline of what inspected entities can expect once they have received notification of an upcoming FDA inspection.

The BIMO inspections and the steps investigators take are further detailed in the Investigations Operations Manual (IOM), the BIMO compliance programs, and the Regulatory Procedure Manual, all of which are available to the public. The full draft guidance can be found here, the guidance is also open to comment until August 5th, 2024, those wishing to comment may do so here.

Clinical Pathways offers a variety of consulting services in inspection readiness and preparedness for not only BIMO inspections but non-BIMO, EMA, and MHRA inspections as well. Consulting services include, but are not limited to:

Inspection Readiness Assessments to identify potential risks or gaps a site may have when it comes to an inspection.

Training and Education for site staff to ensure they are aware of what is to be expected of them during an inspection as well as the proper etiquette and communication strategies to apply throughout.

Mock Inspections which allows staff to get a feeling for what it will be like to be inspected and to identify any issues in their responses.

Post-Inspectional Support Clinical Pathways assists their clients before the inspection, all the way through, and even after the inspection to foster a culture of continuous improvement.

For more information on Clinical Pathways consulting service please visit our website at the following link: https://www.clinicalpathwaysresearch.com/inspection-readiness.

-The Clinical Pathways Team

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