CHAPTER 48 - 7348.809 Bioresearch Monitoring

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

FOOD AND DRUG ADMINISTRATION
COMPLIANCE PROGRAM 	PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	Cover Page — Page 1
CHAPTER 48: Bioresearch Monitoring FINAL
SUBJECT:
INSTITUTIONAL REVIEW BOARDS
IMPLEMENTATION DATE:
04/04/2025
DATA REPORTING
PRODUCT CODES: Bioresearch Monitoring inspections do not require product codes
PROGRAM ASSIGNMENT CODES
09809: Food and Color Additives
41809: Biologics (Human Cellular, Tissue and Gene Therapies)
42809: Biologics (Blood and Blood Products)
45809: Biologics (Vaccines, Allergenic, and Live Biotherapeutic Products)
48809: Human Drugs
83809: Medical Devices
98809: Tobacco Pre-Market Activities
FIELD REPORTING REQUIREMENTS:
Copies of all establishment inspection reports (EIRs) complete with attachments, exhibits, and any
related correspondence are to be submitted promptly to the Center Point of Contact (Center POC).
All EIRs should be completed in accordance with Office of Inspections and Investigations (OII) SOP:
Establishment Inspection Report Classification Process (former FMD No. 86) and the Investigations
Operations Manual (IOM)1, Chapter 5 (Establishment Inspections).
A preliminary summary of inspectional findings, as well as any Form FDA 483 Inspectional
Observations (FDA 483), should be emailed to the Center POC, as agreed to with the center, as
soon as possible, but generally no later than three business days after the inspection has completed.
1 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-
references/investigations-operations-manual

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Contents
PART I – BACKGROUND ................................................................................................................. 4
PART II - IMPLEMENTATION ........................................................................................................... 6
1. 	Objective .................................................................................................................................6
2. 	Program Management Instructions ..........................................................................................6
A. Coverage................................................................................................................................6
B. Inspection Assignments ..........................................................................................................6
C. Remote Regulatory Assessment ............................................................................................6
D. Communication Between the Centers and OII ........................................................................7
E. Responsibilities of OII Investigators, Inspection Team Leaders, & Center Participants ........... 7
F. Inspections of Facilities under the Jurisdiction of the Veterans Affairs .................................... 9
PART III - INSPECTIONAL.............................................................................................................. 10
1. 	General .................................................................................................................................10
2. 	IRB Registration ....................................................................................................................11
3. 	IRB Membership....................................................................................................................12
4. 	Meetings & Meeting Minutes .................................................................................................12
5. 	Written Procedures ................................................................................................................13
6. 	Criteria for Selecting Studies/Time Frame .............................................................................14
7. 	Initial IRB Review of Research ..............................................................................................14
8. 	IRB Review of Research Involving Medical Devices .............................................................. 16
9. 	IRB Review of HUDs - Clinical Use and Use in Research ..................................................... 17
10. Studies Involving Children .....................................................................................................18
11. Continuing IRB Review of Research......................................................................................21
12. Expedited Review ..................................................................................................................21
13. Unanticipated Problems Involving Risks to Human Subjects or Others ................................. 22
14. IRB Reporting to the Clinical Investigator and Institution ....................................................... 23
15. Informed Consent (21 CFR 50.20, 50.25 & 50.27) ................................................................. 23
16. Exception and/or Waiver of Informed Consent....................................................................... 24
17. Emergency Use of a Test Article (21 CFR 56.104(c)) ............................................................ 26
18. Electronic Records and Electronic Signatures ....................................................................... 26
19. Cooperative Research ...........................................................................................................28
PART IV - ANALYTICAL ................................................................................................................. 30
PART V - REGULATORY/ADMINISTRATIVE STRATEGY............................................................. 31
1. 	Classification .........................................................................................................................31

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2. 	Administrative Actions for Noncompliance. ............................................................................ 31
3. 	Follow-Up Inspections ...........................................................................................................32
PART VI 	REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS ................................. 34
1. 	References ............................................................................................................................34
A. FDA Laws .............................................................................................................................34
B. FDA Guidelines, Guidance and Inspection Guides ............................................................... 34
C. Relevant FDA Information Sheets ........................................................................................36
2. 	Program Contacts .................................................................................................................37
PART VII – FDA CENTER AND OFFICE RESPONSIBILITIES ....................................................... 38
1. 	CENTER ...............................................................................................................................38
2. 	OFFICE OF INSPECTIONS AND INVESTIGATIONS ........................................................... 38
3. 	OFFICE OF CLINICAL POLICY .............................................................................................39
Change History
Item 	Change 	Date
Update 	Updated administrative, organizational and computer systems
information
04/16/2018
Update 	Updated VA address for notification to remove Suite 574 at their
request.
09/26/2018
Update 	Full Revision 	03/21/2025

PROGRAM 	7348.809
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PART I – BACKGROUND
In 1977, the Food and Drug Administration (FDA or Agency) established the Bioresearch Monitoring
(BIMO) program to ensure the protection of the rights, welfare, and safety of human subjects
involved in FDA-regulated studies; to verify the quality, integrity, and reliability of clinical study data
submitted to FDA in support of research or marketing applications; and to assess compliance with
statutory requirements and FDA's regulations governing the conduct of clinical studies, including
those for informed consent and ethical review.
Title 21 of the Code of Federal Regulations (21 CFR), parts 50 and 56, provide FDA’s regulations for
the protection of human subjects. These regulations require, among other things, IRB review of all
clinical investigations using FDA-regulated products under sections 505(i) and 520(g) of the FD&C
Act, as well as clinical investigations conducted in support of applications for research or marketing
permits and authorizations for other FDA-regulated products.
FDA’s Office of Inspections and Investigations (OII) conducts inspections of clinical investigators,
sponsors, sponsor-investigators, contract research organizations (CROs), institutional review boards
(IRBs), radioactive drug research committees (RDRCs), nonclinical (animal) laboratories,
bioavailability and bioequivalence studies, post-marketing adverse drug experience reporting, and
risk evaluation and mitigation strategies reporting. These inspections are conducted in support of
preapproval, licensing, premarket, and marketing applications submitted to the agency for products
regulated by FDA product centers as part of the BIMO program, among other activities.
The BIMO program is implemented through multicenter compliance programs (CPs)2 to ensure
regulated entities are operating in accordance with applicable statutes and regulations to verify if
clinical trials follow applicable ethical and quality standards. These CPs were developed to establish
a framework that outlines instructions and expectations for BIMO inspections.
Section 704(a)(5)(D)(i) of the FD&C Act underscores that those subject to BIMO inspection must
provide FDA with access to the information to be inspected (including access to all paper and
electronic records and access to electronic information systems used to hold, analyze, process, or
transfer that information), and permit FDA to inspect relevant facilities and equipment used in
generating that information. At the same time, section 704(a)(5)(D)(ii) makes clear that existing
safeguards against disclosure of confidential commercial information and trade secrets continue to
apply.
In addition to its inspectional authority, section 704(a)(5), FDA may initiate or request to conduct
remote regulatory assessments (RRAs), whenever FDA determines an RRA is appropriate to help
fulfill the Agency's regulatory responsibilities and protect human and animal health. An RRA is an
examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to
evaluate compliance with applicable FDA requirements. RRAs assist in protecting human health,
informing regulatory decisions, and verifying certain information submitted to the Agency.3
2 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-program-
manual/bioresearch-monitoring-program-bimo-compliance-programs
3 See the revised draft guidance for industry Conducting Remote Regulatory Assessments: Questions and Answers
(January 2024). When final, this guidance will represent FDA’s current thinking on this topic. Also see section 704 of the
Federal Food, Drug, and Cosmetic Act.

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Requests for records or other information from establishments subject to section 704(a)(4) of the
FD&C Act, are a type of RRA. Section 704(a)(4) gives FDA the authority to request (and requires
establishments to provide) any records or other information that FDA may inspect under section 704
of the FD&C Act, in advance of or in lieu of inspections of such establishments that engage in the
manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or
facility that is subject to inspection under section 704(a)(5)(C) (i.e., sites, entities, or facilities subject
to BIMO) inspections.

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PART II - IMPLEMENTATION
1. 	Objective
The objectives of the BIMO program are:
• 	To protect the rights, welfare, and safety of subjects involved in FDA-regulated clinical
trials4;
• 	To verify the accuracy and reliability of clinical trial data submitted to FDA in support of
research or marketing applications; and
• 	To assess compliance with FDA’s regulations governing the conduct of clinical trials.
The purpose of this CP is to provide instructions to OII and center personnel for conducting
inspections of IRBs and recommending associated regulatory and/or administrative actions.
2. 	Program Management Instructions
A. Coverage
This program provides for the inspection of domestic IRBs that review and approve clinical
investigations involving human subjects and FDA-regulated products.
B. Inspection Assignments
1) 	Centers, on an annual basis, will select IRBs for surveillance inspections and send OII a
list of IRBs selected for surveillance inspections.
2) 	Centers issue IRB for-cause inspection assignments, with a comprehensive or directed
approach, including background materials.
3) 	Inspection assignments should be issued with due dates according to pre-defined
timeframes.
4) 	Once an inspection assignment has been issued, any requested change in the due date
by the center will be routed through the OII Office of Bioresearch Monitoring Inspectorate
(OBMI) point of contact (POC) and the appropriate OII OBMI division director(s). The
inability of OII OBMI to meet a due date should be immediately communicated to the
appropriate OBMI division director and center POC.
5) 	If the inspection involves a U.S. Department of Veterans Affairs (VA) facility, refer to Part
II Section 2.F. (Inspections of Facilities under the Jurisdiction of the Veterans Affairs) of
this CP for additional instructions.
C. Remote Regulatory Assessment
As part of the IRB surveillance inspection program, centers may select a number of IRBs for
an RRA. The center IRB liaison will identify those IRBs for which the center requests an RRA
be conducted in lieu of an inspection.
4 The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous with
clinical trials for purposes of this CP.

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D. 	Communication Between the Centers and OII
1) 	Prior to an Inspection
a) 	The OII investigator contacts the center POC to notify them that they have been
assigned to conduct the inspection, provide the inspection start date, contact
information for communication during the inspection, obtain special instructions, and
coordinate the logistics of center personnel participation if needed.
b) 	A pre-inspection meeting may be arranged by the center or OII to discuss the
assignment.
2) 	During an Inspection
a) 	The center POC and OII investigator should strive to be accessible to one another
during the inspection.
b) 	The OII investigator contacts the center POC if advice or clarification of the inspection
assignment is needed, or if evidence is uncovered that warrants discussion with the
OII investigator’s supervisor and center personnel.
3) 	After an Inspection
a) 	As soon as possible, but no later than three business days after the conclusion of the
inspection, the OII investigator sends a preliminary summary of inspectional findings
and a copy of any FDA 483 issued to the center POC.
b) 	As soon as possible, OBMI forwards a copy of any written response to the FDA 483
by the inspected party to the center POC. The center POC forwards a copy of any
response to FDA 483 that does not appear to have been shared with the inspecting
OII OBMI Division.
c) 	The center POC consults with the OII investigator and their supervisor as needed
when reviewing the EIR.
d) 	The center determines the final classification and enters the final classification
decision into the appropriate information technology system(s).
e) 	If the center’s final classification is different from the one recommended by OII, the
center should ensure that OII OBMI Division personnel are aware of the change and
reasons for the change.
f) 	The center promptly forwards documentation of the final classification decision and
copies of post-inspectional correspondence issued to the inspected party to the
appropriate OII OBMI division’s correspondence box email address.
E. Responsibilities of OII Investigators, Inspection Team Leaders, & Center Participants
1) 	OII Investigator
The OII investigator's responsibilities include, but are not limited to, the following:
• 	Reviewing inspection instructions and attending pre-inspection meetings (as needed)
prior to the start of the inspection;

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• 	Discussing with OII OBMI Division management the need to adjust the workload in
order to meet specific inspection due dates;
• 	Scheduling domestic inspections and conducting the assigned inspection;
• 	Communicating inspectional observations/issues with institutional officials and IRB
staff during the course of the inspection, as appropriate;
• 	Communicating inspectional observations and issues to the OII investigator’s
supervisor and the center POC;
• 	Preparing and issuing any FDA 483; discussing with institutional officials and IRB staff
any inspectional observations listed on the FDA 483 and/or any discussion items at
the close of the inspection, informing the IRB that they may submit a written response
to the FDA 483;
• 	Preparing and submitting an EIR within established timeframes; and
• 	Participating in post-inspectional discussions with the center, when appropriate.
2) 	Inspection Team Leader
When inspections are conducted by a team, an OII investigator serves as Inspection
Team Leader and is responsible for the cooperative conduct of the inspection. In addition
to the responsibilities listed above, the Inspection Team Leader’s responsibilities include
but are not limited to those listed in the IOM Chapter 5 (Establishment Inspections-Team
Inspections).
3) 	Center Participant
The center participant’s responsibilities include, but are not limited to, the following:
• 	Obtaining OII OBMI approval for participation in an inspection and obtaining FDA
credentials through OII OBMI Immediate Office;
• 	Attending pre-inspection discussions, if and when requested by the Inspection Team
Leader;
• 	Participating in and providing information pertinent to the inspection;
• 	Providing guidance and expertise during the inspection and completing inspection
tasks as directed by the Inspection Team Leader if the center participant is serving as
a subject matter expert (SME) (e.g., auditing documents, preparing inspection notes
and specific sections of the EIR within guidelines and timeframes); and
• 	Providing their written portion of the EIR to the Inspection Team Leader within
timeframes.
4) 	Resolution of Disagreements
If there is disagreement among members of the inspection team, the issue should be
discussed privately and resolved cooperatively. Any difficulties in conducting team
inspections should be discussed with appropriate OII OBMI division management and the
center management, and, if not resolved, referred to OII OBMI Director.

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F. 	Inspections of Facilities under the Jurisdiction of the Veterans Affairs5
1) 	Pre-Inspection
The center may provide the Veterans Affairs Office of Research Oversight (VA-ORO) with
written notification of FDA’s intention to inspect an institutional review board at a VA
facility at the beginning of the fiscal year for IRB surveillance inspections or at the time
that the assignment is issued to OII for for-cause IRB inspections.
This notification can be emailed to the current VA-ORO executive director or sent to the
address below:
Executive Director, Office of Research Oversight (10R)
Veterans Health Administration
U.S. Department of Veterans Affairs
810 Vermont Avenue, N.W.
Washington, D.C. 20420
Telephone: (202) 632-7620
Email: vha10rresearchoversightaction@va.gov
2) 	Post-Inspection
The center will make available, upon request, a copy of any post-inspectional
correspondence with the inspected entity to the VA Office of Research Oversight.
5Memorandum of Understanding Between the U.S. Department of Veterans Affairs, Veterans Health Administration
and the U.S. Department of Health and Human Services, Food and Drug Administration, MOU 225-82-8400,
https://www.fda.gov/about-fda/domestic-mous/mou-225-82-8400

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PART III - INSPECTIONAL
1. 	General
The following instructions apply to inspections of IRBs:
A. The primary focus of an IRB inspection is to evaluate IRB practices and procedures to
determine compliance with the applicable regulations, specifically 21 CFR 50 and 56 and, as
applicable, 21 CFR 312, 812, and 814 to ensure human subject protection. These regulations
apply to clinical investigations of products regulated by FDA. These inspections may include,
but are not limited to, IRB’s written procedures, membership, registration, initial and
continuing IRB review of research.
B. Inspections under this program will be preannounced unless otherwise instructed in the
inspection assignment or a determination is made not to preannounce by OII. The OII
investigator should keep the time span between initial contact and start of the inspection as
short as possible. The OII investigator should immediately report to the OII investigator’s
supervisor, OII division director, and center POC, any attempt by the IRB to delay an
inspection without sufficient justification.
C. The OII investigator contacts the institution to confirm the name and location of the IRB
Chairperson, to determine appropriate time for the inspection, to assure that responsible
individuals are present, and IRB records are available. The OII investigator shall confirm that
the IRB is providing oversight of FDA-regulated research as the IRB of record. For any
inspection attempt where it is determined that the IRB is out of business or it is determined
that FDA does not have jurisdiction (e.g., IRB is not reviewing FDA-regulated research or is
not serving as the IRB of record), the OII investigator will contact the center POC to discuss
converting the inspection (Operation 12) to an investigation (Operation 13).
D. IRB records must be retained for at least three years after the completion of the research,
and accessible for inspection and copying by FDA (21 CFR 56.115(b)). If the OII investigator
encounters a refusal to permit entry or inspection, or a refusal of information, including a
refusal to permit access to or copying of requested records, the appropriate section of IOM
Chapter 5 (Establishment Inspections) and applicable regulatory requirements should be
consulted, and current policy/procedures followed.
E. If the OII investigator observes or suspects regulatory or statutory deviations that may
endanger subject rights, welfare, or safety, they will immediately contact their supervisor, OII
division director, and center POC, and then continue the inspection.
F. 	If possible, OII investigators should attend a convened meeting of the IRB to observe the
IRB’s processes and procedures under 21 CFR 56. The OII investigator may address
questions from the IRB outside of the IRB meeting as part of the inspection.
G. The OII investigator issues a FDA 483 at the conclusion of the inspection when deviations
from applicable regulations are observed. Those inspectional observations that do not reach
the level of significance to be included on the FDA 483 will be discussed during the closeout
discussion with management and reported in the EIR. OII investigators should collect all
records necessary to fully support all FDA 483 observations and discussion items.

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H. The OII investigator informs the IRB that they may submit a written response to the FDA 483
within 15 business days of the end of the inspection to the appropriate OII OBMI division
correspondence email address. Refer to IOM Chapter 5 (Establishment Inspections).
I. 	OII investigators are responsible for conducting inspections and preparing EIRs. The EIR
must include content required by this compliance program and specific assignment
instructions, where applicable. This content should be included by utilizing the headings that
are listed in the CP and the headings as prescribed in the IOM. The EIR must include the
name and address of the IRB Chairperson and should include the name and address of the
head of the institution or Institutional Official at which the IRB is located.
J. 	Documents to be collected and included as an exhibit in each EIR:
1) 	IRB written procedures required by 21 CFR 56;
2) 	Current IRB membership list;
3) 	Examples of IRB meeting minutes to illustrate initial review and approval of studies for
each type of FDA regulated product reviewed, e.g., drugs, biologics, and medical
devices;
4) 	Protocol or protocol summary for each study reviewed including documentation of IND,
IDE, or HDE #, if available; and
5) 	List of FDA-regulated studies for which the IRB is providing oversight as the IRB of
record, if available.
Note: The OII investigator should contact the center POC if it is not feasible to collect the
records identified above.
K. If during the inspection of IRB, the OII investigator becomes aware of complaints or problems
related to a clinical investigator, sponsor, or CRO, they should promptly forward the
information to the appropriate center for evaluation, in accordance with current complaint
handling procedures. The referral should be documented in the endorsement.
2. 	IRB Registration
Every IRB in the United States that reviews FDA-regulated research is required to register and/or
update the IRB’s information on the registration website maintained by the Office for Human
Research Protections (OHRP) at least every three years (21 CFR 56.106).
Determine whether the IRB has registered6 or updated its information as required by 21 CFR
56.106(c) or as described in 21 CFR 56.106(e).
A. Change in IRB’s Contact: If there is a change in the IRB's contact or chairperson, verify that
the IRB revised its registration information within 90 days of the change.
B. Change in Types of FDA-Regulated Products: If the IRB decides to review clinical
investigations involving new types of FDA-regulated products or to discontinue reviewing
clinical investigations regulated by FDA, verify that the IRB updated its registration
information within 30 days of the change.
6 https://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc

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C. Change in Status: When the IRB decides to disband, verify that the IRB updated its
registration to reflect the change in its status within 30 days of permanent cessation of the
IRB's review of research.
D. Change in Name: If the IRB has a name change, identify whether the IRB has updated its
registration information.
3. 	IRB Membership
A. Determine whether the IRB membership has the representation as required by 21 CFR
56.107.
B. Determine whether any IRB member participates in the deliberation or voting during the
initial or continuing review of any study in which that IRB member has a conflicting interest,
other than to provide information requested by the IRB (21 CFR 56.107(e)).
C. Identify whether the IRB has a process for appointing alternate members as substitutes for
primary members for an entire meeting (e.g., when the primary member is not able to attend
the meeting), or at any time during a meeting (e.g., when the primary member has a
conflicting interest and is recused from review of a particular study).
1) 	Identify whether alternate members are listed on the IRB membership list and identified
as to the primary IRB member(s) or representative capacity (e.g., scientific, non-scientific,
non-affiliated) for whom they may substitute at convened meetings.
2) 	Identify whether an alternate member is included in the meeting minutes when the
alternate member replaces a primary member at a convened meeting and whether the
minutes identify the name of the primary member for whom the alternate member is
substituting, and the reason for the substitution.
D. Determine if the IRB maintains a list of IRB members identified by name; earned degrees;
representative capacity; indications of experience such as board certifications, licenses, etc.,
sufficient to describe each member's chief anticipated contributions to IRB deliberations; and
any employment or other relationship between each member and the institution as required
by 21 CFR 56.115(a)(5).
4. 	Meetings & Meeting Minutes
21 CFR 56.108(c) requires that, except when an expedited procedure is used (21 CFR 56.110),
the IRB must review research at convened meetings at which a majority of the members of the
IRB are present, including at least one member whose primary concerns are in non-scientific
areas. For research to be approved, the research must receive the approval of a majority of
those members present at the meeting.
A. Majority (often referred to as quorum) is the minimum number and type of IRB members that
must be present for the IRB to conduct business. For example, if the total IRB membership is
10 (even number of IRB members), then majority is 6 (half of 10 is 5 +1 = 6). If the IRB
membership is 15 (odd number of IRB members), then majority is 8 (half of 15 is 7.5, and
rounding up to the next whole number is 8). Identify whether the IRB’s written procedures
address how a majority is calculated.
B. Determine whether the IRB meeting minutes include attendance at the convened meeting of

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the IRB (21 CFR 56.115(a)(2)).
C. Except when an expedited review procedure was used, determine if the IRB reviewed
proposed research at a convened meeting when a majority of the IRB members were
present, including at least one member whose primary concerns are in non-scientific areas
and that the required membership was maintained throughout the meeting for each vote
taken on FDA-regulated studies (21 CFR 56.108(c)).
The total number of eligible voting members present may change from one agenda item to
the next agenda item. Majority may be lost if:
1) 	The total number of IRB members voting on a particular agenda item falls below the
required number of members that must be present for the IRB to conduct business; or
2) 	At least one of the IRB members counting towards majority does not have primary
concerns in non-scientific areas.
D. Determine whether actions voted on during a convened meeting received approval of a
majority of the IRB members present.
E. Determine whether the IRB has reviewed proposed and ongoing studies at convened
meetings.
F. 	Determine whether the IRB minutes include sufficient detail that shows the actions taken by
the IRB, a vote on these actions including the number of members voting for, against or
abstaining (21 CFR 56.115(a)(2)).
G. Determine whether the IRB meeting minutes include sufficient detail to show the basis for
requiring changes in (to secure approval) or disapproving research (21 CFR 56.115(a)(2)).
H. Determine whether the IRB meeting minutes include a summary of the discussion of
controverted issues and its resolution (21 CFR 56.115(a)(2)).
I. 	Review the IRB's meeting minutes to ascertain whether any IRB member participates in the
initial or continuing review of any project for which the member has a conflicting interest (21
CFR 56.107(e)). Identify whether the IRB maintained quorum if an IRB member is recused
from voting on a specific study because of a conflicting interest.
5. 	Written Procedures
A. Determine whether the IRB maintains and follows written procedures as required by 21 CFR
56.108(a) for:
1) 	Conducting initial and continuing review of research and for reporting findings and actions
to the clinical investigator and institution;
2) 	Determining which projects require review more often than annually and which projects
need verification from sources other than the clinical investigator that no material
changes have occurred since previous IRB review;
3) 	Ensuring prompt reporting to the IRB of changes in research activity; and

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4) 	Ensuring that changes in approved research, during the period for which IRB approval
has already been given, are not initiated without IRB review and approval except where
necessary to eliminate apparent immediate hazards to human subjects.
B. Determine whether the IRB maintains and follows written procedures as required by 21 CFR
56.108(b) for ensuring prompt reporting to the IRB, appropriate institutional officials, and the
FDA of:
1) 	Any unanticipated problems involving risk to human subjects and others;
2) 	Any instance of serious or continuing noncompliance with the regulations or the
requirements or determinations of the IRB; and
3) 	Any suspension or termination of IRB approval.
6. 	Criteria for Selecting Studies/Time Frame
A. The OII investigator should select FDA-regulated studies that reflect current IRB practices,
preferably ones that were initially approved within the previous three years and are presently
ongoing, including study(ies) that have undergone a continuing review. During the
inspection, OII investigators prioritize selection of clinical studies, based on the following
criteria:
1) 	Studies specified in the for-cause inspection assignment if any;
2) 	Safety and efficacy studies of investigational new drugs, devices and/or biologics or
combination products performed under IND (drug or biologic), or IDE application;
3) 	Studies employing novel or cutting-edge technologies (e.g., cell, gene, and tissue-based
therapies);
4) 	Studies involving vulnerable populations (e.g., pediatric studies, refer to 21 CFR 56.107
(a));
5) 	Studies involving an exception from informed consent under 21 CFR 50.24;
6) 	Sponsor-investigator initiated clinical trials;
7) 	Device studies that involve the IRB’s determination as to whether a device study is
significant risk (SR) or non-significant risk (NSR); and
8) 	Studies for which an IND or IDE is not required, e.g. certain marketed drugs and devices,
and NSR devices.
Document the protocol number, full protocol title, sponsor, clinical investigator, IND/IDE/HDE
number, if available, and initial IRB approval date for studies reviewed during the inspection.
7. 	Initial IRB Review of Research
A. Determine whether the IRB has the authority to approve, require modifications in (to secure
approval), or disapprove proposed research (21 CFR 56.109(a)).

PROGRAM 	7348.809
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B. Determine whether officials of the institution approved research that has not been approved
by the IRB (21 CFR 56.112).
C. Identify whether the IRB provides a system for receiving and distributing the materials
submitted to the IRB.
D. Identify if the written procedures describe the method of review utilized by the convened IRB
(e.g., full board review, primary reviewer(s)).
1) 	If the IRB uses a primary reviewer system, identify if the written procedures outline the
role of the primary reviewer, for example, attendance at the IRB meeting, leading the
discussion, etc.
2) 	Identify if the written procedures describe what documents are routinely distributed to all
IRB members and those that may be distributed to specific IRB members (e.g., primary
reviewer(s)). If so, identify what each IRB member receives prior to the convened IRB
meeting.
3) 	Identify if all IRB members have access to copies of the complete submission to the IRB.
If so, describe the mechanism utilized by the IRB members to access the copies of the
complete submission.
A submission package for initial review may include:
• 	Protocol(s)/amendment(s);
• 	Written informed consent document(s) and consent form updates that the clinical
investigator proposes for use in the trial;
• 	Subject recruitment procedures (e.g., advertisements);
• 	Written information to be provided to subjects;
• 	Information about payments and compensation available to subjects; and
• 	Information sheets or instruction summaries given to human subjects, and if
applicable, the clinical investigator’s brochure that includes, but is not limited to, the
summary of information relating to safety and effectiveness in humans obtained
from prior clinical studies, and a description of the drug product.
E. Identify if the written procedures describe how the IRB ensures that clinical investigators
make all modifications initially required by the IRB prior to enrollment of research subjects.
F. 	Determine whether the IRB ensures the requirements set forth in 21 CFR 56.111, Criteria for
IRB Approval of Research, were met prior to approving the research.
G. Describe the IRB's written procedures for determining the effective date of initial approval,
including when the IRB reviews and approves research with conditions without requiring
further review at a subsequent meeting.
H. Identify if the IRB has a mechanism to assess whether the investigator and/or sponsor has
made a determination about whether an IND or IDE is/is not required for a proposed study, if

PROGRAM 	7348.809
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applicable, and the basis for this determination.7
FDA regulations require sponsors and sponsor-investigators to obtain an IND or IDE when
necessary for a particular study (21 CFR 312.20,312.50, and 812.20).
8. 	IRB Review of Research Involving Medical Devices8
The IRB is responsible for making a SR/NSR determination for research involving medical
devices (21 CFR 812.66) unless FDA has already made the risk determination, i.e., an IDE has
been approved or FDA has determined that the study is SR, NSR, or exempt. For NSR medical
device research conducted under 21 CFR 812.2(b)(1)(ii), the IRB serves as FDA’s surrogate for
the review, approval, and continuing review of NSR investigations.
A. Under 21 CFR 812.3(m), the definition of a SR device is one that is:
1) 	Intended as an implant and presents a potential for serious risk to the health, safety, or
welfare of a subject;
2) 	Purported or represented for supporting or sustaining human life and presents a potential
for serious risk to the health, safety, and welfare of a subject;
3) 	For a use of substantial importance in diagnosing, curing, mitigating, or treating disease
and presents a potential for serious risk to the health, safety, or welfare of a subject; or
4) 	Otherwise presents a potential for serious risk to the health, safety, or welfare of a
subject.
FDA does not have a specific definition for an NSR device.
The risk determination is based on the proposed use of a device in an investigation, and not
the device alone. SR studies are those that present a potential for serious risk to the health,
safety, or welfare of a subject. IRBs should consider the potential harm of any associated
procedure as well as the potential harm caused by the device. A device may be determined
to be NSR in one case, while for another indication it may be considered SR.
The NSR designation should not be confused with minimal risk; a term used to identify
certain studies that IRBs may approve through an expedited review procedure. For a device
study to be eligible for expedited review, it must be an NSR study AND present no more than
minimal risk to the subject (21 CFR 56.110). Minimal risk means that the probability and
magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests (21 CFR 56.102(i)).
7 Guidance for IRBs, Clinical Investigators and Sponsors IRB Responsibilities for Reviewing the Qualifications of
Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (2013),
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/irb-responsibilities-reviewing-qualifications-
investigators-adequacy-research-sites-and
8 Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk
Medical Device Studies (2006), http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf

PROGRAM 	7348.809
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B. Risk Determination
The IRB is required to make a risk determination when the sponsor or clinical investigator
presents a device for investigation as SR or NSR. The IRB must review the sponsor’s NSR
determination for each investigational device study reviewed. If the IRB determines that an
investigation presented by the sponsor or clinical investigator as NSR involves significant
risk, the IRB must notify the clinical investigator and where appropriate, the sponsor of the
SR determination (21 CFR 812.66).
1) 	If the IRB reviews research involving medical devices, identify whether the IRB has and
follows written procedures for making the SR/NSR determination for investigational
device research. FDA recommends that IRBs have procedures in place that explain how
the IRB makes the SR/NSR determination and how that determination should be
documented.
2) 	Determine if the sponsor made the initial risk determination of NSR and presented this
information to the IRB. If the IRB agrees with the sponsor that the study is NSR, the IRB
reviews the study using the criteria in 21 CFR 56.111. The study may begin without
submission of an IDE application to FDA and is considered to have an approved
abbreviated IDE. The requirements for abbreviated IDEs can be found at 21 CFR
812.2(b).
3) 	Identify if the IRB has made a determination of SR/NSR for any device studies and
describe how the IRB documented the risk determination. The IRB should make the
SR/NSR determination by reviewing relevant information at a convened meeting and
document the results in the meeting minutes.
4) 	Determine if the IRB informed the clinical investigator and/or sponsor when the IRB
determined the study submitted as NSR has been determined to be a SR (21 CFR
812.66).
9. 	IRB Review of HUDs - Clinical Use and Use in Research9
As defined in 21 CFR 814.3(n), a humanitarian use device (HUD) is a medical device intended
to benefit patients in the treatment or diagnosis of a disease or condition that affects or is
manifested in no more than 8,000 individuals in the United States per year. A Humanitarian
Device Exemption (HDE) is a marketing application for a HUD, which is exempt from
effectiveness requirements and subject to certain profit and use restrictions. HUDs can only be
used in a facility after an IRB has approved its use in the facility, except in certain emergencies.
Full board approval is required to authorize the HUD's use under the HDE at the institution
initially, but expedited review may be used for oversight thereafter.
The use of an HUD itself does not constitute research. However, research may be performed
using the HUD without an IDE when the HUD is used within the approved labeling. Research on
uses of the HUD outside of the approved labeling must follow the IDE regulations.
9 Humanitarian Device Exemption Program Guidance for Industry and FDA Staff (2019), https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program

PROGRAM 	7348.809
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A. Determine if the IRB reviews the use of HUDs in the facility that have an approved HDE. If
so, determine if the IRB has written procedure(s) for initial and continuing review of a HUD
including whether the IRB requires a consent document for the use of the HUD (21 CFR
814.124). If the IRB does not have such procedures, FDA recommends that the IRB have
policies and procedures in place for the review and approval, including whether the IRB
requires a consent document for the use of the HUD.
1) 	A physician in an emergency situation may determine that IRB approval for the use of
the HUD at the facility cannot be obtained in time to prevent serious harm or death to a
patient. In this case, a HUD may be used without prior approval. The physician must
provide notification of the use to the chairperson of the IRB, and the notification must
include the identification of the patient involved, the date of the use, and the reason for
the use (FD&C Act, Section 520(m)(4)). FDA regulations require that physicians provide
such notification to the chairperson of an IRB in writing within 5 days of the emergency
use of the device (21 CFR 814.124 (a)). Determine if the IRB has received notifications
of the emergency use of an HUD that has not been approved for use in the facility.
2) 	An HDE holder may collect safety and effectiveness data in a clinical investigation for
the HDE-approved indications(s) without an IDE. IRB approval (21 CFR 56) and
informed consent of the subjects (21 CFR 50) are still required for the clinical
investigations, as defined in these regulations. Determine if the IRB approved such a
study and verify compliance with the applicable requirements of 21 CFR 50 and 56.
3) 	Investigational use for an indication different from the HDE- approved indication(s) must
be conducted in compliance with the applicable IDE regulations (21 CFR 812), in
addition to complying with the applicable requirements for IRB approval and informed
consent. If the study is a SR study, an FDA- approved IDE is required (21 CFR
812.20(a)(1)). Determine if the IRB approved a study investigating use of a HUD for a
different indication than the HDE approved indication. If so, verify compliance with 21
CFR 812, 50, and 56.
10. Studies Involving Children
If a study involves children as subjects, the IRB must determine that the research study complies
with 21 CFR 50 Subpart D – Additional Safeguards for Children in Clinical Investigations
(Subpart D) (21 CFR 56.109(h)). Subpart D requires that the IRB approve only those clinical
investigations that meet the criteria described in 21 CFR 50.51, 50.52, 50.53, or 50.54. The IRB
must also assure that adequate provisions are made to obtain the assent of the children (if in the
IRB’s judgment the children are capable of agreeing to participate in the study) and the
permission of the children’s parents or guardians as set forth in 21 CFR 50.55 (21 CFR 50.51-
50.55). When the IRB determines that assent from the child is required, it must also determine
whether and how assent must be documented (21 CFR 50.55(g)).
Where parental permission is to be obtained, the IRB may find that the permission of one parent
is sufficient for clinical investigations covered by 21 CFR 50.51 or 50.52 (21 CFR 50.55(e)(1)).
Where clinical investigations are covered by 21 CFR 50.53 or 50.54 and permission is to be
obtained from parents, both parents must give their permission unless one parent is deceased,
unknown, incompetent, or not reasonably available, or when only one parent has legal
responsibility for the care and custody of the child (21 CFR 50.55(e)(2)).

PROGRAM 	7348.809
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If children that are wards of the State are included in the clinical investigation, the study must
meet the requirements in 21 CFR 50.56.
For research involving children as subjects, the IRB must find that the research fits into one of
the following10:
• 	21 CFR 50.51 -- Clinical investigations not involving greater than minimal risk;
• 	21 CFR 50.52 -- Clinical investigations involving greater than minimal risk but presenting
the prospect of direct benefit to individual subjects;
• 	21 CFR 50.53 -- Clinical investigations involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge
about the subjects’ disorder or condition; or
• 	21 CFR 50.54 -- Clinical investigations not otherwise approvable that present an
opportunity to understand, prevent, or alleviate a serious problem affecting the health or
welfare of children.
A. If an IRB reviews research that involves children:
1) 	Determine if the IRB has written procedures describing the IRB’s responsibilities for the
additional safeguards for children involved in clinical research including the
determinations required by 21 CFR 50 Subpart D.
2) 	Determine if the IRB considered including in the membership one or more individuals
knowledgeable about and experienced in working with children as subjects (21 CFR
56.107(a)).
3) 	Identify if the IRB chose to invite individuals with appropriate expertise in studies
involving children to assist the IRB in reviewing the study (21 CFR 56.107(f)).
4) 	If the IRB approved any studies under 21 CFR 50.51, 50.52, and/or 50.53, determine if
the IRB found that the criteria set forth in the applicable regulations were met prior to
approval of the research. For example, that adequate provisions were made for soliciting
the assent of children and permission of their parents or guardians as required in 21 CFR
50.55. Identify where the IRB documented this finding.
5) 	If the IRB approved any studies under 21 CFR 50.54, determine if the IRB found that the
conditions set forth in the regulations were met prior to approval of the research. For
example, that adequate provisions were made for soliciting the assent of children and
permission of their parents or guardians as required in 21 CFR 50.55. Identify where the
IRB documented this finding.
10 Ethical Considerations for Clinical Investigations of Medical Products Involving Children Draft Guidance for Industry,
Sponsors, and IRBs (2022), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ethical-
considerations-clinical-investigations-medical-products-involving-children

PROGRAM 	7348.809
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6) 	For the studies conducted under Subpart D, determine if the IRB found that permission
of the child's parent(s) or guardian(s) was granted in accordance with (21 CFR 50.55(e)-
(f). Identify where the IRB documented this finding.
7) 	For the studies conducted under Subpart D, determine if the IRB found that the children
were capable of providing assent (21 CFR 50.55(a)-(b)). Identify where the IRB
documented this finding.
8) 	If the IRB concluded that assent is not necessary for proceeding with the clinical
investigation, determine if the IRB found that the following criteria under 21 CFR 50.55(c)
were met:
a) 	That the capability of some or all of the children is so limited that they cannot
reasonably be consulted; or
b) 	That the intervention or procedure involved in the clinical investigation holds out a
prospect of direct benefit that is important to the health or well-being of the children
and is available only in the context of the clinical investigation.
Identify where the IRB documented these findings.
9) 	If the IRB waived assent for children participating in research, determine if the IRB found
and documented that the following criteria under 21 CFR 50.55(d) were met:
a) 	The clinical investigation involves no more than minimal risk to the subjects;
b) 	The waiver will not adversely affect the rights, welfare, or safety of the subjects;
c) 	The clinical investigation could not practicably be carried out without the waiver; and
d) 	Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
B. 21 CFR 50.56 Wards
Children who are wards of the state or any other agency, institution or entity may participate
in clinical investigations under 21 CFR 50.51 and 50.52. Children who are wards may only
participate in clinical investigations under 21 CFR 50.53 or 50.54 if the clinical investigation
meets the criteria included in the 21 CFR 50.56.
If children who are wards of the state or any other agency, institution, or entity may be
included in a clinical investigation approved by the IRB under 21 CFR 50.53 or 50.54,
determine if the IRB ensured the regulatory requirements included in 21 CFR 50.56 were
met.

PROGRAM 	7348.809
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11. Continuing IRB Review of Research
A. Determine if the IRB has the authority to approve, require modifications in (to secure
approval), disapprove all research activities, and/or suspend or terminate approval of
ongoing studies (21 CFR 56.109(a) and 56.113).
B. Determine if the IRB conducts continuing review of research at intervals appropriate to the
degree of risk, but not less than once per year in accordance with 21 CFR 56.109(f).
C. Determine whether the IRB followed its written procedures for conducting continuing review
of research (21 CFR 56.108(a)(1)).
1) 	Identify whether the clinical investigator submits reports (e.g., progress reports) to
facilitate continuing review of research as required by the IRB's written procedures.
2) 	Identify if IRB members have access to the information required by the IRB’s written
procedures in order to conduct its continuing review of research.
D. Determine if the IRB was provided with sufficient information to determine whether the study
should be allowed to continue, modified in order to continue, suspended, or terminated.
E. Determine whether the IRB followed the criteria for approval of research as outlined in 21
CFR 56.111 when considering if a study should be allowed to continue.
F. 	Describe how the IRB verifies that the clinical investigator addressed the modifications
required by the IRB to continue the study.
G. Identify how changes in research (protocol amendments, informed consent form changes,
and other revisions) are reviewed and approved by the IRB.
H. Determine if the IRB prepares and maintains adequate documentation of records of
continuing review activities, including copies of progress reports submitted by clinical
investigators and copies of all correspondence between the IRB and the clinical investigators
(21 CFR 56.115(a)(1)(3) and (4)).
I. 	Determine if actions by the IRB on continuing review activities are documented in the
meeting minutes (21 CFR 56.115(a)(2) and (3)).
J. 	Identify where the study approval period, i.e., frequency of review, is documented.
12. Expedited Review
A. Determine whether the IRB’s use of expedited review procedures meets the requirements
of 21 CFR 56.110. Determine if the IRB adopts a method for keeping all members advised
of research proposals which have been approved under the expedited review procedure (21
CFR 56.110(c)).
The list of categories of research that may be approved through expedited review is found in
the Federal Register Notice, Categories of Research That May Be Reviewed by the

PROGRAM 	7348.809
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Institutional Review Board (IRB) Through an Expedited Review Procedure.11
B. Determine whether expedited review procedures are used to approve research other than
the types of research described in 21 CFR 56.110.
13. Unanticipated Problems Involving Risks to Human Subjects or Others
The IRB must follow written procedures for ensuring prompt reporting to the IRB, appropriate
institutional officials, and the FDA of any unanticipated problems involving risks to human
subjects or others (21 CFR 56.108(b)(1)). To fulfill its oversight obligations during the conduct of
a clinical study, an IRB must have, among other things, information concerning unanticipated
problems involving risk to human subjects in the study, including adverse events (AEs) that are
considered unanticipated problems.
For IND studies, clinical investigators are required to “promptly report to the IRB . . . all
unanticipated problems involving risk to human subjects or others” (21 CFR 312.66).
For IDE studies, investigators are required to submit a report of an unanticipated adverse device
effect (UADE) to the sponsor and the reviewing IRB as soon as possible, but in no event later
than 10 working days after the investigator first learns of the effect (21 CFR 812.150(a)(1)).
A. Determine if the IRB follows written procedures for ensuring prompt reporting to the IRB, the
appropriate institutional officials, and the FDA of any unanticipated problems involving risks
to human subjects or others (21 CFR 56.108(b)(1)).
B. Identify if the IRB’s written procedures include information about who is responsible for
promptly reporting to each of the three entities (the IRB, appropriate institutional officials, and
the FDA), the timeframes for reporting, and whether such reports are being submitted in
accordance with the IRB’s written procedures.
C. Identify if the IRB’s written procedures include information about what might qualify as an
unanticipated problem involving risks to human subjects or others, such as types of AEs
(e.g., serious and unexpected AEs) that may be considered unanticipated problems, the type
of information to submit to the IRB regarding an unanticipated problem, and the type of IRB
review for such reports (e.g., full board review vs. expedited review).
D. Describe the IRB’s actions when the IRB reviews an unanticipated problem involving risks to
subjects or others that requires prompt reporting to the IRB under 21 CFR 56.108(b). If the
IRB’s written procedures specify full board review of the unanticipated problem, determine
whether the IRB meeting minutes document the IRB’s action, if any, resulting from that
review (21 CFR 56.115(a)(2)).
11 Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review
Procedure (1998), https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/categories-research-
may-be-reviewed-institutional-review-board-irb-through-expedited-review

PROGRAM 	7348.809
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14. IRB Reporting to the Clinical Investigator and Institution
A. Determine whether the IRB notifies clinical investigators and the institution in writing of the
IRB decisions to approve or disapprove a proposed research activity, or of modifications
required to secure IRB approval of the research activity in accordance with 21 CFR
56.109(e).
B. Identify how the IRB notifies clinical investigators of their responsibility to promptly report
and obtain IRB approval of proposed changes in a research activity, except where necessary
to eliminate apparent immediate hazards to human subjects; and to report unanticipated
problems regarding risks to human subjects or others, any instance of serious or continuing
noncompliance with applicable regulations or the requirements or determinations of the IRB,
and any suspension or termination of IRB approval.
C. Identify whether the IRB has a mechanism for ensuring that clinical investigators are made
aware of their responsibilities for complying with the IRB written procedures (e.g., handbooks
or informational sheets for clinical investigators which describe their responsibilities; letters of
approval to clinical investigators which describe their responsibilities; copy of the IRB written
procedures given to the clinical investigators or posted electronically by the IRB for access by
clinical investigators).
D. If the IRB disapproved proposed research, determine if the IRB provided a statement of the
reasons for its decision and gave the clinical investigator an opportunity to respond in person
or in writing (21 CFR 56.109(e)).
E. Determine if the IRB maintains copies of all correspondence between the IRB and clinical
investigator (21 CFR 56.115(a)(4)).
15. Informed Consent (21 CFR 50.20, 50.25 & 50.27)
The IRB is responsible for reviewing research protocols and related materials, including informed
consent documents, to ensure the protection of the rights, welfare, and safety of human subjects
participating in research and the requirements of 21 CFR 50 are met. Determine if the IRB has
written procedures for reviewing the informed consent document and the informed consent
process, and whether these written procedures were followed.
For the studies selected for review during the inspection:
A. Determine if the IRB reviewed and approved the informed consent document, that includes
the required elements for informed consent under 21 CFR 50.25(a), any of the elements of
21 CFR 50.25(b) that are relevant to the study, and changes and revisions to the informed
consent document.
B. For applicable clinical trials, determine whether the informed consent document includes the
statement required by 21 CFR 50.25(c), “A description of this clinical trial will be available on
https://ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information
that can identify you. At most, the Web site will include a summary of the results. You can
search this Web site at any time.”

PROGRAM 	7348.809
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C. Determine if the IRB reviewed and approved an informed consent document that is in a
language understandable to the prospective subject or legally authorized representative (21
CFR 50.20), e.g., when the research is expected to involve potential subjects who do not
understand English.
D. Determine if the IRB requires documentation of informed consent in accordance with 21
CFR 50.27 (21 CFR 56.111 (a)(5)).
E. Identify whether the IRB has written procedures for determining whether the additional
elements of informed consent (found at 21 CFR 50.25(b)) are material to prospective
subjects’ decision to participate and to be included in the informed consent.
F. 	Identify whether the IRB has written procedures to determine the need and method to inform
currently enrolled subjects of new information that arises during the conduct of the clinical
investigation that could affect a subject’s willingness to continue participation in the clinical
trial.
16. Exception and/or Waiver of Informed Consent
A. Exception from Informed Consent Requirements for Minimal Risk Investigations (21 CFR
50.22)
The IRB responsible for the review, approval, and continuing review of the clinical
investigation may approve an informed consent procedure that does not include or that alters
some or all of the elements of informed consent set forth in the regulations at 21 CFR
50.25(a) and (b), or may waive the requirement to obtain informed consent, provided the IRB
finds and documents certain criteria are met.
1) 	Determine whether the IRB reviewed and approved a waiver or alteration of informed
consent for any clinical investigations.
2) 	If so, determine whether the IRB found and documented that the following criteria for
waiver or alteration were met:
a) 	The clinical investigation involves no more than minimal risk to the subjects;
b) 	The clinical investigation could not practicably be carried out without the requested
waiver or alteration;
c) 	If the clinical investigation involves using identifiable private information or identifiable
biospecimens, the clinical investigation could not practicably be carried out without
using such information or biospecimens in an identifiable format;
d) 	The waiver or alteration will not adversely affect the rights, welfare, and safety of the
subjects; and
e) 	Whenever appropriate, the subjects or legally authorized representatives will be
provided with additional pertinent information after participation.
3) 	Determine whether the IRB found that subjects or legally authorized representatives
were to be provided with additional pertinent information after participation.

PROGRAM 	7348.809
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4) 	Identify whether the IRB has written procedures for waiver or alteration of informed
consent. If so, determine whether the IRB followed its written procedures.
B. Exception from General Requirements for Informed Consent (21 CFR 50.23)
21 CFR 50.23 allows for the use of a test article with an exception from the requirements of
informed consent in certain situations.
1) 	Prior to the use of the test article
If informed consent is not obtained before the use of the test article, determine if the IRB
confirmed that the clinical investigator and a physician who is not participating in the
clinical investigation certify in writing all of the following:
a) 	The subject was in a life-threatening situation necessitating the use of the test article;
b) 	Informed consent could not be obtained from the subject due to an inability to
communicate with or obtain legally effective informed consent from the subject;
c) 	Time was not sufficient to obtain consent from the subject’s legal representative; and
d) 	There was no available alternative method of approved or generally recognized
therapy that provided an equal or greater likelihood of saving the life of the subject.
2) 	After the use of the test article
If the immediate use of the test article is required to preserve the life of the subject and
time is not sufficient to obtain an independent determination as required in 21 CFR
50.23(a) before the use of the test article, verify that the determination was made by the
clinical investigator and within five working days after the use of the article was reviewed
and evaluated in writing by a physician who is not participating in the clinical investigation
(21 CFR 50.23(b)).
3) 	If the test article is used without informed consent in accordance with 21 CFR 50.23(a)
and (b), determine if it was reported to the IRB within five working days after the use of
the test article (21 CFR 50.23(c)). If it was not reported within five working days, what
action did the IRB take?
4) 	If the IRB has written procedures for the use of a test article per 21 CFR 50.23(a) and (b),
determine if the IRB follows its written procedures.
C. Exception from Informed Consent Requirement for Emergency Research (21 CFR 50.24) 12
1) 	If the IRB has written procedures for review and approval of clinical investigations
involving exception from informed consent for emergency research under 21 CFR 50.24,
determine whether the IRB follows its written procedures.
2) 	If the IRB responsible for the review, approval, and continuing review of the clinical
investigation involving an exception from informed consent approved the clinical
investigation without requiring informed consent, determine if the IRB:
12 Exception from Informed Consent Requirements for Emergency Research (2013), https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research

PROGRAM 	7348.809
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a) 	Included the concurrence of a licensed physician who is a member of or consultant
to the IRB, and who is not otherwise participating in the clinical investigation; and
b) 	Found and documented that each of the requirements in 21 CFR 50.24(a)(1-7) are
met.
3) 	Determine if the IRB has addressed procedural requirements in 21 CFR 50.24 (b, c, &
e).
17. Emergency Use of a Test Article (21 CFR 56.104(c))
Emergency use means the use of a test article on a human subject in a life-threatening situation
in which no standard acceptable treatment is available, and in which there is not sufficient time to
obtain IRB approval (21 CFR 56.102(d)).
In accordance with the regulations at 21 CFR 56.104(c), emergency use of a test article is
exempt from the requirements of IRB review provided that such emergency use is reported to the
IRB within five working days. Any subsequent use of the test article at the institution is subject to
IRB review.
A. Determine if the IRB ensured that the emergency use of the investigational product met all of
the conditions in 21 CFR 56.102(d).
B. Determine if the emergency use of the investigational product was reported to the IRB within
five working days.
C. Determine if the IRB is aware of any subsequent use of the investigational product at the
institution without its review and approval.
D. Identify if the IRB has established written procedures for the emergency use of
investigational products and confirm whether the IRB follows these procedures in emergency
use situations.
18. Electronic Records and Electronic Signatures13
Electronic systems, electronic records, electronic signatures, and handwritten signatures
executed to electronic records used by an IRB may be subject to regulations found in 21 CFR
Part 11, Electronic Records and Electronic Signatures. In general, 21 CFR 11 requirements
apply to electronic records and electronic signatures and to the electronic systems used by IRBs
to create, modify, maintain, archive, retrieve, or transmit records required by 21 CFR 56.115.
Regardless of the type of electronic system used by the IRB, an important principle to
understand when evaluating IRB records is that the regulatory requirements for adequate
documentation of IRB activities do not change whether the documentation is captured on paper,
electronically, or using a hybrid approach.
13 See the Draft Guidance for Industry Electronic Systems, Electronic Records, and Electronic Signatures in Clinical
Investigations: Questions and Answers (March 2023).See also Guidance for Industry Part 11, Electronic Records;
Electronic Signatures - Scope and Application (August 2003).

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART III — Page 27
In general, as stated in the 2003 Part 11 guidance14, the Agency intends to exercise enforcement
discretion regarding certain Part 11 provisions for validation, record copying, record retention,
and audit trails (refer to 21 CFR 11.10(a), (b), (c), and (e), respectively). Therefore, compliance
with applicable regulatory requirements on recordkeeping, record copying, and record retention
will be evaluated in accordance with appropriate predicate rules (e.g., 21 CFR 56.115). Prior to
noting an observation on an FDA 483 regarding non-compliance with Part 11, discuss the issue
with your supervisor and the center POC.
A. Identify what electronic systems, including software and hardware, if any, are used by the
IRB to create, modify, maintain, archive, retrieve, or transmit electronic records and obtain
electronic signatures documenting IRB activities.
1) 	Explain how the IRB determines which records (e.g., IRB submission records, meeting
minutes, membership lists, notifications to an investigator and institution, etc.) are
created, modified, maintained, archived, retrieved, or transmitted in electronic format.
2) 	Identify if the IRB has written procedures, user-manuals, access policies and procedures
on the operational use of the electronic system that may include the following processes:
a) 	System setup/installation and maintenance;
b) 	Electronic system user training;
c) 	System security measures (e.g., back-up, firewalls, antivirus, and anti-spy software);
d) 	Alternative recording methods (in case of system unavailability);
e) 	Access controls and authorization checks for user's actions; and
f) 	Delegated roles and responsibilities of authorized users.
3) 	Determine if the IRB limits access to authorized individuals and uses authority checks to
ensure that only authorized individuals can use the system, electronically sign a record,
access the operation or computer system input or output device, alter a record, or
perform the operation at hand.
4) 	Describe the extent of the authorized individual's access, privileges, and restrictions
(e.g., read-only access to IRB communications to the investigator, etc.). Include how
authorized users access the systems (e.g., use of username and password combinations,
multifactor authentication, biometrics), and whether access rights (security credentials)
are deactivated when a user is no longer required or permitted to use the IRB or
institution’s electronic system.
5) 	Determine whether individuals who develop, maintain, or use the electronic system have
the education, training, and experience to perform their assigned tasks.
14 See the Draft Guidance for Industry Electronic Systems, Electronic Records, and Electronic Signatures in Clinical
Investigations: Questions and Answers (March 2023).See also Guidance for Industry Part 11, Electronic Records;
Electronic Signatures - Scope and Application (August 2003).

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART III — Page 28
6) 	Identify backup, disaster recovery, and/or contingency plans to protect against record
loss. Were there any installed software upgrades, security or performance patches, or
new instrumentation that affected the electronic records?
7) 	Document any instances in which the electronic system did not function as it was
intended. Describe any system failures or error messages that resulted in loss of
electronic records and whether the incident was reported (for example, to the IRB,
appropriate institutional official, and FDA). Describe the corrective actions, if any, that
were taken.
19. Cooperative Research15
Under 21 CFR 56.114, institutions involved in multi-institutional studies may use joint review,
reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of
duplication of effort. For multicenter studies, an institution’s IRB may serve as a central IRB, an
institution’s IRB may rely on the review of research by a centralized IRB (in whole or in part) in
place of its own IRB review of the study, or it can conduct its own review of the study.
A. Identify whether the IRB’s policies outline under what circumstances the institution’s IRB
may participate in a centralized review process and the role of the institution’s IRB in that
process.
1) 	Institution’s IRB serving as the central IRB (IRB of record)
a) 	Identify whether a signed agreement exists between the institution, its IRB, and
participating IRBs in the multi-institutional research.
b) 	Identify if the IRB provided a copy of the agreement to the institution and the clinical
investigator.
c) 	Describe the specific responsibilities of the central IRB for conducting initial and
continuing review of the research.
d) 	Identify if the institution’s IRB serving as the central IRB has written procedures in
place to implement the centralized review process. For example, procedures on how
the central IRB intends to communicate with relevant institutions, the institutions’ IRB,
and clinical investigators regarding its review and how the central IRB ensures that it
provides meaningful consideration of relevant local factors for communities from
which the research subjects are drawn.
e) 	Identify if IRB meeting minutes or other records document whether relevant local
community issues were considered in the review of the research.
f) 	Identify if the signed agreement apportions IRB review responsibilities between the
central IRB and local IRBs where the multicenter studies are conducted. Identify if the
IRB serving as the central IRB has written procedures describing how it will
implement its responsibilities under the agreement.
2) 	Institution’s IRB relying on the review of research by a central IRB (IRB of record)
15 Using a Centralized IRB Review Process in Multicenter Clinical Trials (2006), https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/using-centralized-irb-review-process-multicenter-clinical-trials

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART III — Page 29
a) 	Identify whether a signed agreement exists between the institution, institution’s IRB
relying on the central IRB, and the central IRB.
b) 	Identify if the institution’s IRB provided a copy of the agreement to the institution and
the clinical investigator.
c) 	Describe the specific responsibilities of the institution’s IRB when relying on the
central IRB’s conduct of initial and continuing review of the research.
d) 	Identify how the institution’s IRB determines that the central IRB is qualified to review
and approve research conducted at the institution.
e) 	Identify if the institution’s IRB relying on the central IRB has written procedures in
place to implement the centralized review process.
f) 	Identify if the signed agreement apportions IRB review responsibilities between the
central IRB and institution’s IRB for the multicenter studies conducted at the site.
Determine if the institution’s IRB has written procedures describing how it will
implement its responsibilities under the agreement.

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART IV — Page 30
PART IV - ANALYTICAL
No analytical activities are planned under this program.

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART V — Page 31
PART V - REGULATORY/ADMINISTRATIVE STRATEGY
The following information is to be used in conjunction with the instructions in OII SOP: Establishment
Inspection Report Classification Process to determine the OII OBMI division recommended
classification and center final classification of inspections of IRBs.
1. 	Classification
A. No Action Indicated (NAI) - No objectionable conditions or practices were found during an
inspection, or the significance of any objectionable conditions found do not justify further
regulatory action.
B. Voluntary Action Indicated (VAI) - Objectionable conditions or practices were found, but the
Agency is not prepared to take or recommend any regulatory action since the objectionable
conditions or practices do not meet the threshold for regulatory action.
C. Official Action Indicated (OAI) – Objectionable conditions or practices were found, and the
scope, severity, or pattern of violations(s) support a finding that:
1) 	Subjects participating in studies approved by the IRB would be or have been exposed to
an unreasonable and significant risk of illness or injury; or
2) 	Subjects’ rights, welfare, or safety would be or have been seriously compromised; or
3) 	Data integrity or reliability is or has been compromised.
The OII OBMI division should consult with the center POC when an OAI classification is
recommended to allow for discussion of the recommendation.
The center is responsible for the final classification of inspections. The center is also
responsible for drafting and developing all regulatory and enforcement letters for OAI
inspections. Post-inspectional correspondence for VAI inspections may identify significant
issues and, when needed, state that FDA expects prompt, voluntary corrective action by the
institutional review board. Post-inspectional correspondence for NAI inspections issued by the
center may indicate that no objectionable conditions or practices were identified that would
justify enforcement action.
2. 	Administrative Actions for Noncompliance
A. Advisory, administrative, and judicial actions may be pursued based on the inspectional
observations and will be in accordance with applicable regulations. FDA can invoke other
legal sanctions under the Federal Food, Drug, and Cosmetic Act (FFDCA) and/or Title 18 of
the United States Code (U.S.C.), where appropriate. If apparent noncompliance with FDA
regulations in the operation of an IRB is observed during an inspection, the FDA may move
forward with the following advisory and/or regulatory actions, as appropriate (21 CFR
56.120):
1) 	Issuing an Untitled Letter may be considered when the violations do not meet the
threshold of regulatory significance for a Warning Letter;

PROGRAM 	7348.809
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2) 	Issuing a Warning Letter may be considered when the violation meets the threshold of
regulatory significance and there is a reasonable expectation that the responsible firm
(e.g., IRB) will take prompt corrective action;
3) 	Reinspecting to confirm the adequacy of corrective actions;
4) 	Withholding approval of new studies subject to 21 CFR 56 that are conducted at the
institution or reviewed by the IRB;
5) 	Directing that no new subjects may be recruited for ongoing studies;
6) 	Terminating ongoing studies when doing so would not endanger subjects; and
7) 	Notifying relevant federal and state agencies, and other parties of the noncompliance.
B. Disqualification of an IRB or institution (21 CFR 56.121). If an IRB or the institution has failed
to take adequate steps to correct the noncompliance stated in the letter sent by the agency
under 21 CFR 56.120(a), and the Commissioner of the FDA determines the disqualification of
the IRB or parent institution is justified, FDA may institute proceedings in accordance with the
requirements for a regulatory hearing set forth in Part 16 (21 CFR 56.121(a)).
Disqualifications may occur if:
1) 	The IRB has refused or repeatedly failed to comply with any of the regulations set forth in
21 CFR 56; and
2) 	The noncompliance adversely affects the rights, welfare, or safety of the human subjects
in a clinical investigation.
FDA will issue an order that explains the basis for the determination and will send a
notice of disqualification to the IRB and the parent institution.
FDA will not approve an application for a research permit (e.g., IND) for a clinical
investigation that is to be under the review of a disqualified IRB or that is to be conducted
at a disqualified institution and may refuse to consider in support of a marketing
application or permit the data from a clinical investigation that was reviewed by a
disqualified IRB.
C. Actions alternative or additional to disqualification (21 CFR 56.124). The FDA may institute
appropriate judicial proceedings (civil or criminal) and other regulatory action through the
Department of Justice at any time. The FDA may also refer the matter to other federal, state,
or local agencies for any action they determine to be appropriate.
3. 	Follow-Up Inspections
A. OII OBMI division follow-up actions, including re-inspection, will be made at the request of the
center. Centers should evaluate whether the violations found indicate systemic problems with
the conduct of the study or the reliability of the data and whether additional inspection
assignments should be issued (e.g., clinical investigator, sponsor).
B. Following issuance of a Warning Letter, centers should schedule a follow-up inspection to
verify if the IRB is fulfilling the terms of any corrective action plan and is in compliance with

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART V — Page 33
applicable regulations. Such follow-up inspections should take place within one year after the
date of the last Warning Letter correspondence, depending on the nature of the violations.

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART VI — Page 34
PART VI 	REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS
1. 	References
A. FDA Laws
Federal Food, Drug, and Cosmetic Act (FD&C Act)
1) 	Most Relevant 21 CFR Regulations
Part 50 – Protection of Human Subjects
Part 56 – Institutional Review Boards
Part 312 – Investigational New Drug Application
Part 812 – Investigational Device Exemptions
2) 	Other 21 CFR Regulations
Part 11 - Electronic Records; Electronic Signatures
Part 814 - Premarket Approval of Medical Devices (includes HDE Requirements in
814.100)
Part 320 – Bioavailability and Bioequivalence Requirements
B. FDA Guidelines, Guidance, and Inspection Guides
1) 	General
Inspection Processes: Investigations Operations Manual (IOM) Chapter 5 (Establishment
Inspections).
2) 	Relevant FDA Guidance
Guidance documents and information sheets pertaining to good clinical practice (GCP)
and the conduct of clinical studies are accessible on FDA’s website:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Below is not
an all-inclusive list.
a) 	Key Information and Facilitating Understanding in Informed Consent Guidance for
Sponsors, Investigators, and Institutional Review Boards, March 2024
b) 	Institutional Review Board (IRB) Review of Individual Patient Expanded Access
Submissions for Investigational Drugs and Biological Products, Guidance for IRBs
and Clinical Investigators, September 2023
c) 	Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors, August
2023
d) 	Electronic Systems, Electronic Records, and Electronic Signatures in Clinical
Investigations: Questions and Answers, March 2023

PROGRAM 	7348.809
Date of Issuance: 04/04/2025 	PART VI — Page 35
e) 	Ethical Considerations for Clinical Investigations of Medical Products Involving
Children, Draft Guidance for Industry, Sponsors, and IRBs, September 2022
f) 	FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-
19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional
Review Boards, August 2021
g) 	Humanitarian Device Exemption (HDE) Program Guidance for Industry and Food and
Drug Administration Staff, September 2019
h) 	Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical
Investigations - Guidance for Sponsors, Investigators, and Institutional Review
Boards, October 2018
i) 	Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and
IRBs, May 2018
j) 	Minutes of Institutional Review Board (IRB) Meetings- Guidance for Institutions and
IRBs, September 2017
k) 	Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers
- Guidance for Institutional Review Boards, Investigators, and Sponsors, December
2016
l) 	Guidance for IRBs, Clinical Investigators, and Sponsors Considerations When
Transferring Clinical Investigation Oversight to Another IRB, May 2014
m) Investigational New Drug Applications (INDs) - Determining Whether Human
Research Studies Can Be Conducted Without an IND - Guidance for Clinical
Investigators, Sponsors, and IRBs, September 2013
n) 	IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of
Research Sites, and the Determination of Whether an IND/IDE is Needed - Guidance
for IRBs, Clinical Investigators, and Sponsors, August 2013
o) 	Exception from Informed Consent Requirements for Emergency Research: Guidance
for Institutional Review Boards, Clinical Investigators, and Sponsors, April 2013
p) 	Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after
Clinical Investigation Approval, February 2012
q) 	Guidance on Exculpatory Language in Informed Consent, August 2011
r) 	Guidance for Institutional Review Boards (IRBs) Frequently Asked Questions – IRB
Registration, July 2009
s) 	Adverse Event Reporting to IRBs — Improving Human Subject Protection - Guidance
for Clinical Investigators, Sponsors, and IRBs, January 2009

PROGRAM 	7348.809
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t) 	Guidance for Industry: Computerized Systems Used in Clinical Investigations, May
2007
u) 	Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors:
Process for Handling Referrals to FDA under 21 CFR 50.54 – Additional Safeguards
for Children in Clinical Investigations, December 2006
v) 	Guidance for Industry: Using a Centralized IRB Review Process in Multi-Center
Clinical Trials, March 2006
w) FDA Institutional Review Board Inspections Guidance for IRBs, Clinical Investigators,
and Sponsors, January 2006
x) 	Guidance for Industry: IRB Review of Stand-Alone HIPPA Authorizations Under FDA
Regulations, October 2003
y) 	Guidance for Industry: Part 11: Electronic Records, Electronic Signatures -- Scope
and Application, August 2003
z) 	General Principles of Software Validation; Final Guidance for Industry and FDA Staff,
January 2002
3) 	Relevant FDA Information Sheets
a) 	Information Sheet, Payment and Reimbursement to Research Subjects, Guidance for
IRBs and Clinical Investigators, January 2018
b) 	Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Waiver of
IRB Requirements for Drug and Biological Product Studies, October 2017
c) 	Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: FDA
Institutional Review Board Inspections, January 2006
d) 	Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors:
Frequently Asked Questions About Medical Devices, January 2006
e) 	Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant
Risk and Nonsignificant Risk Medical Device Studies, January 2006
f) 	Information Sheet, Institutional Review Boards Frequently Asked Questions,
Guidance for Institutional Review Boards and Clinical Investigators, January 1998
g) 	Information Sheet, Recruiting Study Subjects, Guidance for Institutional Review
Boards and Clinical Investigators, January 1998

PROGRAM 	7348.809
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2. 	Program Contacts
A. When medical, technical, or scientific questions or issues arise from a specific assignment or
if additional information is required about a specific assignment, consult the center POC
identified in the assignment.
1) 	For operational questions, contact:
Office of Inspections and Investigations (OII)
Office of Bioresearch Monitoring Inspectorate (OBMI) - OII OBMI Immediate Office
Inspection POC, OIIbimoinspectionpoc@fda.hhs.gov
2) 	For questions about GCP and CP issues specific to a center product area, contact:
Center for Drug Evaluation and Research (CDER)
Office of Compliance (OC)
Office of Scientific Investigations (OSI)
BIMO-CDEROSI@fda.hhs.gov
Center for Biologics Evaluation and Research (CBER)
Office of Compliance and Biologics Quality (OCBQ)
Division of Inspections and Surveillance (DIS)
CBERBIMONotification@fda.hhs.gov
Center for Devices and Radiological Health (CDRH)
Office of Clinical Evidence and Analysis
Division of Clinical Policy and Quality
BIMO-CDRH@fda.hhs.gov
Human Foods Program (HFP)
HFP-BIMO@fda.hhs.gov
Center for Tobacco Products (CTP)
Office of Compliance and Enforcement (OCE)
CTP-BIMO@fda.hhs.gov
Center for Veterinary Medicine (CVM)
Office of Surveillance and Compliance
CVMBIMORequests@fda.hhs.gov
3) 	For crosscutting questions about GCP policy and program issues impacting the agency’s
BIMO programs, contact:
Office of Clinical Policy (OCLP)
Office of the Chief Medical Officer (OCMO)
gcpquestions@fda.hhs.gov

PROGRAM 	7348.809
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PART VII – FDA CENTER AND OFFICE RESPONSIBILITIES
1. 	CENTER
A. Select IRBs for surveillance inspections based on the centers’ internal processes and sends
OII a list of IRBs selected for surveillance inspections.
B. Identifies and issues IRB for-cause inspection assignments and provides background
materials to OII.
C. Communicates specific concerns, if any, to the OII investigator prior to inspection.
D. Addresses inquiries regarding IRB inspection assignments and compliance issues.
E. Participates in inspections as a SME, if needed. Refer to Part II (Implementation) of this CP
for additional information regarding responsibilities of center participants when participating
on an inspection.
F. 	Provides guidance and support to the OII investigator during all phases of inspections and
investigations.
G. Reviews and evaluates EIRs, attachments/exhibits, and regulatory recommendations from
OII OBMI divisions.
H. Submits regulatory (administrative/advisory) actions to the Office of Chief Counsel (OCC), if
applicable.
I. 	Determines final classifications of inspections, enters the classification into the appropriate
information technology system, and notifies OII of the final classification decision.
J. 	Issues post-inspectional correspondence to the inspected entity.
K. Initiates and develops follow-up regulatory (administrative/advisory) actions, as appropriate.
L. 	Promptly provides copies of all relevant correspondence between the inspected firm and FDA
to the OII OBMI division.
2. 	OFFICE OF INSPECTIONS AND INVESTIGATIONS
A. OFFICE OF BIORESEARCH MONITORING INSPECTORATE
1) 	Provides inspection quality assurance, training of OII personnel, and operational
guidance.
2) 	Maintains liaison with centers, OII OBMI divisions, and OCLP, and resolves operational
questions.
3) 	Receives and reviews for-cause IRB inspection assignments from the centers via OII
OBMI Immediate Office Inspection POC email and forwards to the appropriate division.
4) 	Tracks inspection assignments and accomplishments.

PROGRAM 	7348.809
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5) 	Reviews and approves the center requests to participate in BIMO inspections or
investigations, and coordinates credentialing for center participants.
B. DIVISION OF FIELD ENFORCEMENT
1) 	Works with center personnel on behalf of OII, on all administrative warrants and
disqualification actions; also liaises with centers to ensure coordination of cases.
2) 	For disqualification actions, issues the Notice of Opportunity for a Hearing (NOOH) to the
IRB and the parent institution.
3. 	OFFICE OF CLINICAL POLICY
1) 	Addresses key clinical policy issues across the FDA’s regulated product centers.
2) 	Serves as the FDA focal point for Good Clinical Practice (GCP) and Human Subject
Protection (HSP) issues related to FDA-regulated clinical trials.
3) 	Sets priorities for the development of GCP and HSP policy.
4) 	Works to ensure consistency in GCP and HSP policy across the agency.
5) 	Participates in international GCP and HSP harmonization activities and serves as the
liaison to other federal agencies and external stakeholders committed to the protection of
human research participants.