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UUSOP-2: FDA Inspections

Supplement B - Remote Regulatory Assessments

Version Date: August 26, 2025

  1. Introduction and Purpose
  2. Definitions and Acronyms
  3. Procedure
  4. Materials Required
  5. References
  6. Revision History


Introduction and Purpose 

During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) modified its operations to allow remote assessments of compliance for FDA-regulated products and associated clinical trials. These “Remote Regulatory Assessments” (RRAs) were utilized to conduct oversight, mitigate risk, and meet critical public health needs in the face of travel restrictions and other barriers to its traditional oversight activities (i.e. Bioresearch Monitoring (BIMO) inspections).

In July 2025, FDA published final guidance entitled “Conducting Remote Regulatory Assessments – Questions and Answers”. This guidance describes FDA’s intention to continue the practice of RRAs as a supplemental tool in its oversight and compliance activities for FDA-regulated products and clinical trials.

RRAs may be performed prior to an inspection; following an inspection, to assess implementation of Corrective and Preventative Action plans (CAPAs); in lieu of an inspection; as part of a request for records or information; or otherwise as part of FDA’s surveillance activities.

UUSOP-02 and UUSOP-02 Supplement A describe the procedures for FDA inspections of a clinical site or investigator at the University of Utah. FDA does not consider RRAs to be inspections as defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), and are therefore subject to slightly different expectations and procedures. However, many similarities exist between these assessments, and University of Utah investigators and staff should treat RRAs with the same gravity as an FDA inspection.

This SOP Supplement describes the procedures for accommodating and conducting a Remote Regulatory Assessment.

 

Definitions and Acronyms 

Clinical Research: Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.

Clinical Trial: Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.

CAPA: Corrective and Preventative Action
ERICA: Electronic Research Integrity Compliance Administration
FDA: United States Food and Drug Administration
FD&C: Federal Food, Drug, and Cosmetic Act
GCP: Good Clinical Practice
HIPAA: Health Insurance Portability and Accountability Act
IC: Inspection Coordinator
IDE: Investigational Device Exemption
IND: Investigational New Drug
IRB: Institutional Review Board
OHRP: Office for Human Research Protection
PHI: Protected Health Information
PI: Principal Investigator
RRA: Remote Regulatory Assessment
SOP: Standard Operating Procedure

 

Procedure

  1. Notification and Scheduling an RRA
    1. An FDA representative should contact the study PI to schedule an RRA in a similar fashion to scheduling an inspection. If any other person at the University is made aware of a request from an FDA representative to schedule or conduct an RRA, immediate notification of the PI must take place.
      1. The FDA representative should inform the PI of the records that are requested for review, as well as the method in which FDA intends to review these records.
      2. UUSOP-02 describes the persons and offices to be notified of an FDA inspection; these same persons and offices should be notified of an RRA.
    2. UUSOP-02 describes the information to be obtained during the initial request for an RRA. In addition, personnel should ask whether the request for an RRA is mandatory or voluntary.
      1. Participation in a voluntary RRA is not required. However, declining to participate in a voluntary RRA may lead FDA to consider other avenues of assessing compliance or obtaining the information the Agency is requesting, up to and including an FDA inspection.
        1. FDA intends to obtain written consent from the site/investigator prior to a voluntary RRA.
      2.  Participation in a mandatory RRA is not optional. Refusal to participate in a mandatory RRA may carry the same consequences as refusing an FDA inspection, which may include formal regulatory or enforcement action.
    3. FDA representatives may offer to hold a separate meeting to discuss considerations, logistics, and technical capabilities for an RRA prior to confirming and scheduling the RRA. Such meetings should be accepted if offered, and attended by all University personnel who will participate in the RRA.
      1. If FDA does not offer to hold a pre-RRA meeting, it is appropriate and recommended to request one.
    4. In the event a study team has reason to believe or is made aware an RRA is likely to occur, the Office of Quality Compliance and Clinical Research Support Office should be notified immediately, as described in UUSOP-02, to allow internal resources to support the study team as necessary.
    5. The identification of an Inspection Coordinator (IC) and the creation of a Record of Inspection should occur as described in UUSOP-02.
  2. Preparation for the RRA
    1. Preparation for an RRA should mirror the preparation for an inspection, as described in UUSOP-02.
    2. The records, documents, or other materials requested by FDA should be made available electronically as discussed with the FDA representative(s).
      1. FDA may determine the method in which records are to be provided during the RRA (e.g. FDA Adobe Connect, encrypted email, etc.). If FDA does not specify the required platform, records should be uploaded to a University-approved, HIPAA-compliant document storage system (e.g. uBox, eReg).
      2. Read-only access to a study’s database may be requested.
      3. Paper documents that are made electronic for the RRA should be saved and uploaded as PDFs.
    3. If the RRA will involve teleconference, screen-sharing, virtual interviews, or livestreaming of facilities for virtual inspection, FDA may determine the method (e.g. FDA Microsoft Teams, FDA Zoom for Government). If FDA does not specify the required platform, a University-approved, HIPAA-compliant system should be used (e.g. UHealth Zoom, Microsoft Teams). Technological performance, adequacy, and internet connection should be confirmed prior to the RRA.
  3. Conduct of the RRA
    1. The conduct of an RRA should generally mirror the conduct of an FDA inspection, as described in UUSOP-02, including fulfillment of requests and professional behavior during the RRA.
    2. An opening meeting may or may not be conducted by FDA.
      1. FDA does not intend to issue an FDA Form 482 at the initiation of an RRA, and one should not be requested.
    3. Regular communication with the FDA representative should occur, as discussed during scheduling and/or the opening meeting. This may involve a daily summary meeting.
    4. FDA may share observations or findings during the course of the RRA. Efforts should be made to address deficiencies during the RRA as described in UUSOP-02.
    5. At the conclusion of the RRA, FDA may choose to conduct a closeout meeting. At this meeting, FDA may present a written list of observations (if any are noted).
      1. If provided, the written list of observations should be submitted to the IRB via the ERICA system as a report form of information.
      2. FDA does not intend to issue an FDA Form 483 at the conclusion of an RRA, even if objectionable practices are noted, and one should not be requested.
  4. Post RRA
    1. Post-RRA activities should mirror the activities performed post-FDA inspection, as described in UUSOP-02 and UUSOP-02 Supplement A. 
      1. If a written list of observations is provided to the study team, a written response should be generated as described in UUSOP-02, and submitted to FDA within 15 business days. 
      2. FDA intends to provide a written copy of the narrative portion of the RRA report to the site, following FDA’s determination that the RRA is closed. This report should be submitted to the IRB as a follow-up report form.
      3. The Record of Inspection should be maintained as described in UUSOP-02.
    2. FDA may perform an inspection as a follow-up action after an RRA is completed. An inspection may be conducted to confirm appropriate implementation of corrective and preventative action; to formally document RRA findings in an FDA Form 483; or to obtain records that were not available during the RRA.

 

Materials Required

References 

  • FDA Guidance Document, June 2025: “Conducting Remote Regulatory Assessments – Questions and Answers”
  • FDA Draft Guidance Document, October 2023: “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities – Guidance for Industry”
  • 21 CFR 312.58, 68: Inspection of records and reports
  • 21 CFR 812.145: Inspections

 

Revision History 

Version Date

Change Summary

26Aug2025

Original Version

 

Printed or photocopied versions are considered unofficial copies unless it is the original signed document.
Last Updated: 9/24/25