Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)

This is a draft guidance. Not for implementation.

What You Need to Know? 👇

What are the key differences between FDA BIMO inspections and regular facility inspections?

BIMO inspections specifically focus on bioresearch monitoring to assess data integrity and participant safety in clinical and nonclinical studies. They evaluate compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations, unlike general facility inspections.

How much advance notice does FDA typically provide for BIMO inspections?

FDA generally pre-announces BIMO inspections with reasonable advance notice. Domestic inspections receive shorter notice via phone, while foreign inspections get longer advance notice due to country clearance requirements. However, unannounced inspections may occur if prior notification could compromise the inspection.

What electronic records access must establishments provide during BIMO inspections?

Establishments must provide FDA with read-only access to electronic information systems used to hold, analyze, process, or transfer study data. They should also be prepared to provide electronic copies, storage media, or paper copies of requested records during the inspection.

What is the recommended timeframe for responding to FDA Form 483 observations?

FDA encourages establishments to provide written responses within fifteen (15) U.S. business days after the inspection end date. Timely responses addressing identified issues are generally considered before further Agency action and may impact subsequent regulatory decisions.

Can FDA conduct BIMO inspections at international sites for US marketing applications?

Yes, FDA conducts international BIMO inspections when studies conducted outside the US support marketing applications submitted to FDA. These inspections follow the same processes as domestic inspections, except FDA presents credentials instead of issuing a notice of inspection.

What should be included in an effective response to FDA Form 483 observations?

Responses should address each observation separately, indicate agreement or disagreement with rationale, provide corrective and preventive actions with timelines, include completed and planned actions, describe effectiveness monitoring methods, and submit supporting documentation like SOPs and training records.

---

What You Need to Do 👇

Recommended Actions

1. Review and understand FDA’s BIMO compliance programs applicable to your establishment
2. Prepare electronic information systems to provide appropriate FDA access during inspections
3. Ensure availability of knowledgeable staff and relevant records during announced inspections
4. Establish process for timely response to Form FDA 483 observations (within 15 business days)
5. Implement proper documentation practices for corrective and preventive actions
6. Maintain contact information for FDA OBIMO division and center points of contact
7. Develop procedures for managing both announced and unannounced inspections
8. Train staff on inspection procedures and communication practices with FDA personnel
9. Establish process for translating documents if conducting studies internationally
10. Review and maintain compliance with applicable FDA regulations and statutory requirements

Key Considerations

Non-clinical testing

• Inspections conducted to determine compliance with Good Laboratory Practice (GLP) requirements
• Inspections of nonclinical laboratories conducting Animal Rule-specific studies
• EPA data audit inspections may be conducted

Software

• Establishments using electronic information systems must provide access to FDA personnel
• FDA can view electronic records via read-only access
• Establishments should be prepared to provide electronic copies or paper copies of requested records

Safety

• Program designed to assess protection of rights, safety and welfare of human trial participants and animal subjects
• Inspections conducted to evaluate potential noncompliance or safety issues raised in complaints

Other considerations

• Pre-announcement practices depend on inspection type and are explained in compliance programs
• Inspection duration varies based on operation complexity, staff availability, observations nature
• Written responses to Form FDA 483 observations encouraged within 15 business days
• International inspections follow same processes as domestic ones with few exceptions
• FDA collaborates with international regulatory partners for joint inspections

---

Relevant Guidances 🔗

• Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies
• Clinical Investigator Disqualification Procedures and Administrative Actions
• IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
• Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies

Related references and norms 📂

• 21 CFR 10.115: Good Guidance Practices
• 21 CFR 310.305: Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications
• 21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences
• 21 CFR 329.100: Reporting Requirements for Over-the-Counter Human Drug Products
• 21 CFR 600.80: Postmarketing Reporting of Adverse Experiences
• 21 CFR 803: Medical Device Reporting
• 21 CFR 806: Medical Devices; Reports of Corrections and Removals

---

Original guidance

• Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations
• HTML / PDF
• Issue date: 2024-06-05
• Last changed date: 2024-10-01
• Status: DRAFT
• Official FDA topics: International, Biopharmaceutics, Investigation & Enforcement, Animal & Veterinary, IVDs (In Vitro Diagnostic Devices), Bioequivalence, HUD/HDE, Generic Drugs, Radiation-Emitting Products, Clinical Trials, Inspection, Dietary Supplements, Investigational New Animal Drug (INAD), Drugs, Compliance, Premarket, Biologics, Investigational Device Exemption (IDE), Tobacco, Biosimilars, Medical Devices, Food & Beverages, Vaccines, Investigational New Drug Application (INDA), Postmarket, Premarket Approval (PMA), New Animal Drug Application (NADA), Food & Color Additives, Administrative / Procedural
• ReguVirta ID: 81db3d49639ed8bf9e5a67c43f447fe0