Mock Inspection Advice From Former Regulatory Investigator

By Alia Legaux, D.H.Sc., Clinical Research Services Consultants, LLC (CRSC)

Mock inspections in clinical research are practice sponsor audits designed to simulate inspections by regulatory authorities (e.g., FDA, EMA, MHRA, PDMA, Health Canada). Some common reasons to conduct a mock inspection include:

• Readiness assessment: Test investigator sites, sponsors, and vendors, such as CROs, before real inspections or critical milestones (e.g., DBL, NDA/MAA)
• Gap identification: Detect protocol, ICH GCP, and SOP noncompliance; data integrity and ALCOA+ issues; TMF completeness; safety reporting gaps
• Process stress test: Evaluate monitoring, data management, pharmacovigilance, IMP management, and vendor oversight under inspection conditions
• Training: Prepare investigators, study coordinators, CRAs, and functional leads on answering investigator/inspector questions and handling document requests

Effective mock inspections are a critical tool for identifying compliance gaps and preparing for actual regulatory authority inspections. Best practices involve meticulous planning, realistic execution, and comprehensive follow-up to ensure continuous readiness. Consider the following best practices when preparing for, conducting, and following up on mock inspections.

Before The Mock Inspection

Define Purpose, Scope, Objectives, And Goals:

• Select a program or specific clinical trials for the mock inspection scope, with priority on pivotal clinical trials considering their significance as evidence to support regulatory authority approval of the investigational product.
• Clearly set objectives to focus on specific processes, such as GCP, BIMO, GMP, GLP, or regulatory standards.
• Establish the purpose and goals of the mock inspection, such as readiness assessment, gap analysis, process test, practice, training exercise, etc.

Confirm The Mock Investigator/Inspector, Strategy, And Duration:

• Identify and use mock investigators/inspectors with actual experience conducting regulatory authority inspections.
• Work with the selected auditor to establish your preparation strategy and approach (i.e., hats on/hats off investigator/inspector role approach, joint regulatory authority assessment).
• Consider whether the regulatory authority uses an agenda for actual inspections. For example, do not use an agenda for FDA inspections unless absolutely necessary, since FDA investigators do not issue and follow inspection agendas.
• Considering the strategy selected, confirm the mock inspection duration (i.e., three to five days, depending on budget size) to accomplish the intended scope, objectives, and goals.

Prepare Your Team, Space, Documents, And Tools:

• Train staff on the inspection process and flow, internal SOP on inspection management, staff roles and responsibilities, study review, common inspection observations, and how to answer questions clearly and confidently.
• Practice mock interviews, demonstrate document retrieval, and timeliness of responses to ensure efficiency in preparation for the actual inspection. A delay in retrieving documents could signal to regulators that a document may not exist or a staff member does not know its location. 
• Prepare a front (inspection) room, back room, and any extra spaces needed for interview preparation and briefing, along with appropriate equipment in the designated room (i.e. monitors, laptops, and printers only in the back room).
• Assign clear roles, such as inspection lead, front room host, backroom coordinator, runners, scribe or notetaker, and SMEs per functional areas.
• Prepare inspection management guides, plans, and trackers; communication log; request log; and SME routing process.
• Compile, update, and organize all key documents (SOPs, training records, batch records, CAPAs, and TMF) for efficient retrieval.
• Brief your receptionist about the possibility of an investigator/inspector's arrival, including whom to inform and the order of notification (i.e., call log adherence).

During The Mock Inspection

Follow A Standard Inspection Process:

• Start with an opening meeting, then conduct facility walk-throughs, review documents, interview staff, hold a daily debrief, and end with an exit meeting.
• Emphasize the evaluation on common risk areas such as data integrity, electronic systems, and actual processes vs. documented ones.

Track Requests: 

• Assign scribes to capture every question, request, and comment from the mock investigator/inspector, which supports facilitating requests and future reference to clarify misunderstood questions or requests and inaccurate or inappropriate responses.
• Log each document provided and retain a copy.
• Consider using AI tools to assist with accurate, real-time note-taking.

Maintain Professionalism: 

• Approach the inspection with a cooperative and professional attitude.
• Avoid being defensive or confrontational, as this can negatively impact the outcome by creating a tense environment that creates significant barriers to effective communication, collaboration, and problem solving. 

After The Mock Inspection

Debrief, Remediate, And Track:

• Host an internal debrief meeting to summarize findings, classify and categorize noncompliance issues, and assign corrective and preventive actions (CAPAs).
• Incorporate the mock inspection findings into your standard system for managing audit observations.
• Implement CAPAs and use a system to track resolutions until gaps are closed and effectiveness checks completed (where necessary).
• Conduct detailed lessons learned sessions to identify and fix gaps potentially in other clinical trials or programs.

Repeat:

• Conduct a follow-up mock inspection, if necessary, based on the findings from the initial mock inspection, investigational product program status, company goals for inspection readiness, etc.
• Make mock inspections a recurring part of your quality management system (QMS) to continuously improve readiness.

Choosing Your Mock Investigator/Inspector

Consider that there is no one-size-fits-all mock inspection. Mock inspections should be tailored for your organization, purpose, and goals, using auditors with prior experience conducting actual regulatory authority inspections.  CRSC is dedicated to planning and implementing mock inspections specific to the client needs.

About The Author:

Alia Legaux, D.H.Sc., has 25 years of clinical research regulation, emphasized by her time as an FDA investigator. Her expertise lies in monitoring, inspecting, training, and auditing clinical investigator sites, CROs, sponsors, ethics committees, and vendors.

During her tenure at the FDA, she was an integral part of the International Inspection Cadre and secured regulatory enforcement actions in the Bioresearch Monitoring (BIMO) program area. Following her departure from the FDA, Dr. Legaux has assisted clients in achieving inspection readiness through diverse services, including training, gap analyses, mock inspections, and quality assurance audits for investigational medicinal products and medical devices.

Her work is centered on enhancing compliance and fostering a thorough understanding of regulatory obligations within the clinical research environment, ultimately assisting organizations with a personalized approach in preparing for successful inspections and upholding quality standards to identify and mitigate risks.