Clinical Trials Inspectional Background

The FDA is one of the first regulatory agencies to conduct

regular inspections of investigators, sponsors, and institutional
review boards that are involved in clinical trials that intend to
support a marketing application.

The FDA Bioresearch Monitoring program (BIMO) was

initiated in 1977, incorporating the Clinical Inspection Program
by the task force that included representatives for the areas of
drugs, biologics, medical devices, and veterinary medicine and
food.

It was expanded to the CDRH (Center of Devices and

Radiological Health) in June 1992. Under the Bioresearch
Monitoring Program, the FDA conducts regulatory inspections
of sponsors, institutional review boards, clinical investigators,
and nonclinical laboratories involved in the testing of
investigational products.

Although ICH-GCP is not specifically defined in FDA

regulations, one of the goals of BIMO is to demonstrate
adherence to FDA-GCP.
FDA Inspection

Food and Drug Administration (FDA)

FDA is the United States regulatory authority charged with,
among other responsibilities, granting IND and NDA approvals.
The US FDA is charged to protect the public health by
overseeing several areas including drugs, medical devices,
biologics, cosmetics, radiation-emitting electronic products,
veterinary products and foods.
Food and Drug Administration (FDA) protects public health and
ensures compliance with the Food, Drug and Cosmetic Act is by
conducting inspections of clinical trial investigators, clinical trial
sponsors, Institutional Review Boards (IRB) and facilities that
manufacture, process or pack FDA-regulated products. 

Inspection

The act by a regulatory authorities (FDA, DCGI and MHRA)

conducting official review of documents, facilities, records, and
any other resources that are deemed by the authority to be
related to the clinical trial and that may be located at the Site of
the trial, Sponsor’s and/or CRO’s facilities, Other
establishments deemed appropriate by the regulatory authority

• Inspection refers to drug supervision and management

authorities’ official evaluation of the documents,
implementation, recording and other aspects of a clinical trial.
Inspection can take place in the trial institute, location of the
sponsor, or venue of the contract research organization (CRO).

BIMO Program
The Bioresearch Monitoring (BIMO) Program was established
to assure the quality and integrity of data submitted to the
agency in support of new product approvals, as well as, to
provide for protection of the rights and welfare of the thousands
of human subjects involved in FDA regulated research.

FDA BIMO Inspection

FDA developed its BIMO Program to help ensure the protection

of the rights, safety, and welfare of human research subjects
involved in FDA-regulated clinical trials, 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 statutory requirements and FDA's regulations governing the
conduct of clinical trials.
Among other activities, the FDA BIMO Program involves site
visits to clinical investigators, sponsors, monitors, contract
research organizations, Institutional Review Boards (IRBs),
nonclinical (animal) laboratories, and bioequivalence analytical
laboratories.
Purpose of the FDA Inspection
The purpose of this compliance program is to provide
instructions to the field and Center personnel for conducting
inspections of sponsors, contract research organizations (CROs),
and monitors, and recommending associated
administrative/enforcement actions.

1- Determine if operations are in compliance with the laws and

regulations administered by FDA

2- Evaluate manufacturing methods, facilities & controls

3-Collect evidence to support regulatory action when violations

are identified
Objectives
1-To protect the rights, safety, and welfare of subjects involved
in FDA‐regulated clinical trials

2-To verify the quality, accuracy and reliability of clinical trial

data submitted to FDA in support of research or marketing
applications

3- To assess compliance with FDA's regulations governing the

conduct of clinical trials.

Who Is Inspected?

_ Clinical Investigator Sites

_ Institutional Review Boards

_ Sponsors, CRO’s, Monitors of Clinical Investigations

_ Bioequivalence Laboratories and Facilities

_ Good Laboratory Practice (GLP) Inspections

Program Objectives
BIMO program consists primarily of on-site inspections and
data audits designed

To monitor all aspects of the conduct and reporting of FDA

regulated research.

The objectives of the inspection are described as follows:

1-To assure the quality and integrity of data submitted to the

FDA in support of new product approvals,

2-To provide for protection of the rights and welfare of

human subjects involved in FDA regulated research,

3-To assure adherence to FDA regulatory requirements and

GCP.

This program is the basis of the FDA preapproval process

for new medicines, medical devices, food and color additives,
and veterinary products introduced to the U.S. consumer.

WHAT IS BIMO?
BIMO programs are used to inspect Good Laboratory Practices
(GLP) study facilities, clinical investigators (CI), or sponsors/
contract research organizations (CRO)/monitors. The BIMO
compliance programs help to assure the integrity of scientific
testing and the reliability of test data submitted to FDA. BIMO
inspections (audit procedures or real-time) allow the agency to
assess whether safety and effectiveness or bioequivalence data
of regulated drug products submitted to FDA are acceptable.
This assessment includes a determination if adequate data
integrity measures are in place for electronic data collection
(EDC) systems.
BIMO programs are overseen by the Office of Surveillance and
Compliance’s (OSC) Premarket Compliance and Administrative
Actions Team (HFV-234, formerly known as the BIMO Team).
CVM monitors the conduct of pre-approval studies with three
compliance programs:
1. Clinical Investigators- These inspections will look at an
investigator conducting a study under Good Clinical
Practice (GCP) Guidelines, typically an effectiveness study
(including laboratory effectiveness studies), or a particular
clinical investigator for a multi-site effectiveness study.
 2. Good Laboratory Practice Compliance Program-
Inspections under this program will look at studies and
facilities conducting studies under Good Laboratory
Practices (GLPs) 21 CFR Part 58. It is important to
understand that a GLP facility is not necessarily or always
by default considered a CRO. See below for more
information on the legal definition of CRO.

3. Sponsors, Contract Research Organizations (CRO), and

Monitors- These inspections are intended to evaluate the
sponsor’s responsibilities under 21 CFR 511.1 and 514. As
examples, ONADE may request this type of inspection as
1) a follow-up to a clinical investigator inspection(s) that
had questionable results of a systematic nature (e.g.,
perceived inadequate monitoring), 2) if there are numerous
clinical investigators with small case numbers, 3) if the
source data have been moved from clinical investigator to
sponsor, or 4) for a foreign study.

Types of Inspections Performed by the FDA

BIMO inspections can be conducted at any stage of clinical
development. The selection of sites to inspect will be done
according to a set of criteria and program assignments.

FDA performs four different types of inspections at many

different types of facilities, and your company’s response should
be tailored to the specific type of event. Facilities that fall under
FDA’s watchful eye include:
 Drug manufacturers
 Device manufacturers

 Blood banks

 Food processing facilities

 Dairy farms

 Animal feed processors

 Compounding pharmacies relevant to your FDA inspects

 Facilities that conduct studies in people

 Laboratories that conduct studies in animals (when used to

support FDA approval of medical products)

FDA’s inspection authority also extends to foreign
manufacturing and processing sites for FDA-regulated products
sold in the United States. Fall within these bounds, and you can
anticipate an FDA inspection at your facility. For the scope of
this article, though, we will focus specifically on the inspection
of medical device manufacturers. 
The four different types of inspections conducted by FDA are
pre-approval inspection, routine inspection, compliance follow-
up inspection, and “for cause” inspection.  Each is intended to
help protect the public from unsafe products, but the focus and
expectations of each type of inspection are different.
Pre-Approval Inspections are conducted after a company
submits an application to FDA to market a new product. These
inspections focus on verifying data included in the application,
and confirming that the facility is capable of manufacturing said
product. The outcome of a pre-approval inspection is that
inspectors will recommend for or against FDA approval.
Routine Inspections are mandated by law every 2 years for class
II and class III device manufacturers.  They follow a prescribed
method known as Quality System Inspection Technique (QSIT),
If a serious public health risk is identified during a routine
inspection, the inspection type may then switch to a “for cause”
inspection.
QSIT identifies the four major subsystems of the quality system:
Management Controls, Design Controls, Corrective and
Preventive Actions (CAPA), and Production and Process
Controls. It evaluates and describes the purpose and importance
of each subsystem, providing flowcharts and inspectional
objectives for each subsystem. There are two types of QSIT
inspections: Level I Abbreviated and Level 2 Baseline. 
A Level 2 Baseline QSIT inspection is a comprehensive
inspection covering all four major subsystems. It is conducted
when a firm has never had a Level 2 inspection, and every six
years thereafter. It provides an overall evaluation of the quality
system.
A Level 1 Abbreviated QSIT inspection is conducted after a
firm has had a Level 2 inspection, and the quality system was
found to be in compliance with all requirements. A Level 1
inspection always includes the CAPA subsystem, plus one other
major subsystem. A different subsystem will be chosen for each
subsequent Level 1 inspection.
Compliance Follow-Up Inspections review actions taken by a
firm/manufacturer in response to a previous inspection that
resulted in significant 483 observations or a Warning Letter. A
compliance follow-up is conducted to verify the adequate
correction of previous violations, to document continuing
violations, or to support future regulatory action.
“For Cause” Inspections investigate a specific problem that has
been reported to FDA. The source of the report can be the
manufacturer , consumer/user complaints, or even a disgruntled
employee.  A “for cause” inspection will focus on the particular
issue, but can branch out to cover unrelated elements of the
firm’s operations. These inspections typically are more in-depth
than routine inspections, and they may not follow a QSIT
approach.

These inspections are initiated when problems are identified

during the FDA review process or due to complaints reported to
the FDA from (1) other agencies, (2) sponsors or monitors, (3)
institutions or institutional review boards, (4) site personnel, or
(5) study subjects or the public.

These inspections are carried out in response to specific

information that raises concerns of possible fraudulent activities
or complaints.
Surveillance inspections:
These inspections are typically done for GLP facilities and
Sponsor/CRO/Monitor. Surveillance inspections are typically
requested by regulatory

What is the difference between audit and inspection?

Difference between Audit and Inspection

Audit Inspection
Auditors are employed of the Inspector are employed by
company who work for a active government, through the
clinical quality assurance agency of the regulatory or
(CQA) function (i.e. competent Authority (i.e.
Sponsor/CRO) FDA/DCGI)D

To ensure that a site is To ensure that trial related

complying obligations and acceptability of
with Protocol, SOP, GCP and resultant clinical data is in
Applicable regulatory support of a new drug
requirements. approval.
Audit Inspection
• Carried out either during or •Usually carried out after the
after the research research
• Proposing improvement •Proposing improvement
suggestion for the current trial suggestion for
• Responsibility of sponsor future trials
• Not all trial data have been •Responsibility of drug
obtained supervision and
• Objectiveness: to ensure the management authorities
trial implementation and data •Usually all data have been
are up to high standard obtained
•Judging whether the data can
be used
to fully evaluate drug effects
and
safety, and determining
whether the
drug can be allowed into the
market
When and how are clinical investigator inspections
conducted?

FDA conducts both announced and unannounced inspections of

clinical investigator sites, typically under the following
circumstances:

 Routinely to verify the accuracy and reliability of data that

has been submitted to the agency;
 As a result of a complaint to the agency about the conduct of
the study at a particular investigational site
 In response to sponsor concerns
 Upon termination of the clinical site
 During ongoing clinical trials to provide real-time assessment
of the investigator’s conduct of the trial and protection of
human subjects;
 At the request of an FDA review division; and
 Related to certain classes of investigational products that FDA
has identified as products of special interest in its current
 work plan (i.e., targeted inspections based on current public
health concerns).
 Enrollment
 Time since last inspection
 Protocol violations
 Serious Adverse Events
 Subject deaths
 Number of studies per site/PI
How are clinical investigator inspections conducted?

1- Upon arrival at the clinical investigator study site, the FDA

investigator will display his/her FDA credentials and issue a
completed Form FDA 482 (Notice of Inspection) to the clinical
investigator or appropriate study staff.
FDA is authorized at reasonable times to access, inspect, and
copy any required records related to the clinical investigation.

2- During an inspection at the site of a clinical investigator, the

FDA investigator typically verifies compliance with the
regulations governing the use of investigational products and
human subject protections and inspecting records and talking to
individuals involved in the conduct of the study to ascertain
 Who performed various aspects of the protocol for the study
(e.g., who verified inclusion and exclusion criteria, who
obtained informed consent, who collected adverse event data);
 Whether the IRB approved the protocol, informed consent
form, and any amendments to the protocol prior to
implementation
 Whether the clinical investigator and study staff adhered to
the sponsor’s protocol and investigational plan and whether
protocol deviations were documented and reported
appropriately
 Whether informed consent documents were signed by the
subject or the subjects’ legally-authorized representative prior
to entry in the study (i.e., performance of any study-related
procedures)

 Whether authority to conduct aspects of the study was

delegated, and if so, how the conduct of the study was
supervised by the clinical investigator
 where specific aspects of the investigation were performed
 how the study data were obtained and where the study data
were recorded
 accountability for the investigational product, including
shipping records and disposition of unused investigational
product
 whether the clinical investigator disclosed information
regarding his financial interests to the sponsor and/or interests
of any sub investigator(s), spouse(s) and dependent children
 the monitor’s communications with the clinical investigator
 the monitor’s evaluations of the progress of the investigation;
and
 Corrective actions in response to previous FDA inspections, if
any, and regulatory correspondence or sponsor and/or monitor
correspondence.

The FDA investigator also may audit the study data by

comparing the data filed with the agency or the sponsor, if
available, with records related to the clinical investigation.

Such records may include the case report forms and supporting
source documentation including signed and dated consent forms
and medical records including, for example, progress notes of
the physician, the subject’s hospital chart(s), and the nurses’
notes.

These records may be in hard copy and/or an electronic format.

For electronic records and/or electronic signatures, the FDA
investigator may gather information to determine whether 21
CFR part 11 requirements have been met

FDA may also examine subjects’ medical records that are part of
the clinical investigation and predate the study to verify whether
the condition under study was in fact diagnosed, the study
eligibility criteria were met, and whether the subject received
any potentially interfering medication prohibited by the
protocol.

The FDA investigator may also review subjects’ records

covering a period after completion of study-related activities to
determine if there was proper follow-up as outlined in the
protocol, and if the clinical investigator submitted all reportable
adverse events (including all clinical signs and symptoms).

For more information about the procedures FDA uses during

inspections of clinical investigator sites, see FDA’s Compliance
Program Guidance Manual (CPGM), Bioresearch Monitoring,
Clinical Investigators and Sponsor-Investigators, Program.

WHAT HAPPENS AFTER AN INSPECTION?

At the end of an inspection, the FDA investigator conducts an

exit interview with the clinical investigator or his/her
representative.
At this interview, the FDA investigator who conducted the
inspection reviews and discusses the findings from the
inspection and, if deficiencies were found, issues a written Form
FDA 483 (Inspectional Observations; 483) to the clinical
investigator or his/her representative.
The 483 describes any inspectional observations that, in the
opinion of the FDA investigator conducting the inspection,
represent deviations from applicable statutes and regulations.

Some common deficiencies that have been observed by FDA

investigators during a clinical investigator inspection include:
 failure to follow the investigational plan and signed
investigator statement/agreement (e.g., failure to conduct or
supervise the study in accordance with the relevant, current
protocol•
 Protocol deviations (e.g., failure to appropriately document
and report any medically necessary protocol deviations).
 Inadequate recordkeeping.
 Inadequate accountability for the investigational product.
 Inadequate subject protection, including informed consent
issues.

The clinical investigator may respond to the 483 observations

orally during the exit interview and/or respond in writing after
the inspection.
If the clinical investigator chooses to respond in writing to the
deficiencies listed on the 483, the response should be directed to
the FDA District Office listed in the upper left corner of the 483.

FDA investigator who conducted the inspection prepares a

written Establishment Inspection Report (EIR). The EIR, Form
FDA 483 (if issued), copies of any materials collected during the
inspection, and any clinical investigator response that has been
received by the District Office are forwarded to the appropriate
FDA Center for further evaluation and final classification of the
inspection outcome.

After this review, one of the following types of letters is

typically sent from the appropriate FDA Center to the clinical
investigator:
(1) A letter that generally states that FDA observed basic
compliance with pertinent regulations. Note that a letter is
not always sent when FDA observes no significant
deviations.

(2) An Informational or Untitled Letter that identifies

deviations from statutes and regulations that do not meet the
threshold of regulatory significance for a Warning Letter.
Generally, such letters may request a written response from the
clinical investigator.
(3) A Warning Letter that identifies serious deviations from
applicable statutes and regulations. A Warning Letter is issued
for violations of regulatory significance.

Significant violations are those violations that may lead to

enforcement action if not promptly and adequately corrected.
Warning Letters are issued to achieve voluntary compliance, and
include a request for correction and a written response to the
agency.

(4) A Notice of Initiation of Disqualification Proceedings and

Opportunity to Explain (NIDPOE).
FDA may initiate a process to disqualify the clinical investigator
from receiving investigational new drugs and/or biologics if
disqualified investigational devices if disqualified if the
investigator has repeatedly or deliberately failed to comply with
applicable regulatory requirements or has deliberately or
repeatedly submitted false information to the sponsor or FDA in
any required report.
The NIDPOE identifies alleged violations and provides the
investigator with an opportunity to explain the matter at an
informal conference or in writing. If, in response to the
NIDPOE, the investigator provides an explanation that is
accepted by the agency and the disqualification is not warranted,
alternatives such as a detailed corrective action plan may be
considered.

If the investigator’s explanation is not accepted by the agency,

the agency may issue a Notice of Opportunity for Hearing
(NOOH).
To help ensure prompt corrective action by the clinical
investigator and to help ensure the protection of research
subjects, FDA provides copies of warning letters and NIDPOEs
to the study sponsor and reviewing IRB.
In addition, following final classification of the inspection by the
FDA Center, the inspection results are shared with the FDA
division assigned to review the marketing submission.

The assigned review division considers the results of the

inspection during its review of the sponsor’s marketing
submission. If the inspection reveals serious violations of FDA’s
clinical investigation regulations (e.g., failure to follow the
investigational plan), the assigned review division may request
additional analyses of the study data or may reject the affected
data in certain situations where FDA considers the data
unreliable.

FDA also posts final clinical investigator inspection

classifications15 as well as warning letters, NIDPOEs, and other
information about clinical investigators who have been
disqualified or restricted in their ability to receive investigational
products on its website:

Explain the details of FDA form 482 and form 483?

Basic Inspectional Forms

1-Separate notice for each inspection (Notice of Inspection

Form FDA 482)

2-Attachment to FDA 482: Resources for FDA Regulated

Businesses Completion of inspection: report in writing
(Inspectional Observations Form FDA 483)
 A list of observations made during the inspection that is
communicated at the conclusion of the inspection.
 The observations are listed in descending order of importance
 The list is a snap-shot of observations noted, not an all inclusive
list

3-If samples collected: receipt for samples (Receipt for Samples

Form FDA 484)

What to do at the conclusion of an inspection and after when

issued a Form 483:

 Take time with the inspector at the conclusion of the inspection

to review the Form 483
o Gain an understanding of observations noted and assure their
accuracy
o Understand the broader message the agency is sending
o Identify and discuss any errors in observations
o Ask questions!
o Demonstrate awareness of applicable regulations
o Consult with legal counsel as necessary
 Respond formally in writing
o Not required, but demonstrates good practice
o Address to the District Director with a courtesy copy to the lead
investigator
o Respond within 15 days or the agency does not have to consider
the response in their decisions for subsequent actions

Taking the opportunity to ask questions and understand the

observations noted in the 483 prior to the inspector leaving the
site will help formulate a future response and implement
corrective action plans. Challenges or questions to the
observations noted are not uncommon, as long as the focus is on
the issues and not the inspector personally. If convincing
information is provided regarding an observation, it may be
deleted from the 483.

Establishment Inspection Report

After the inspection, the inspector will write an Establishment

Inspection Report (EIR) and submit it to FDA headquarters

After the report has been evaluated you will receive one of three
letters:
No action indicated (NAI): No objectionable conditions or
practices were found during the inspection, or the significance of
the objectionable conditions does not justify further FDA action
No Action Indicated: the inspected party is in compliance

Voluntary Action Indicated (VAI): Objectionable conditions

were found and documented, but the FDA is not prepared to take
or recommend further regulatory action because the
objectionable conditions are few and do not seriously impact
subject safety or data integrity

Voluntary Action Indicated: minor deviations are observed, and

voluntary correction action is requested from the inspected party

Official Action Indicated (OAI): Regulatory violations

uncovered during the inspection are repeated or deliberate
and/or involve submission of false information to FDA or to the
sponsor.
Official Action Indicated: serious noncompliance requiring
regulatory or administrative action by the FDA against the
inspected party (e.g., data unacceptable).
OAI may results in
Warning letter (WL)
Violations can be corrected through specific action(s) by the
investigator and adherence to the corrective action plan has a
high probability of preventing similar or other violations in the
future
Notice of Initiation of Disqualification Proceedings and
Opportunity to Explain (NIDPOE)
Repeatedly or deliberately failed to comply with the
requirements for conducting clinical trials

Repeatedly or deliberately submitted false information to FDA

or to the sponsor

What is a Warning Letter?

After a Form 483 is issued and the inspector completes the

Establishment Inspection Report, the agency may issue a
Warning Letter. A Warning Letter indicates that higher FDA
officials have reviewed the observations and that a serious
violation may exist. This formal notification allows for
voluntary and prompt correction action. 
 A Warning Letter:

 Includes evidence collected to support observations and

provides further explanation
 Establishes a background of warnings should further action be
required by the FDA
 Might be hand-delivered or the agency may invite top corporate
management to a meeting at the District Office or Center
 The site must reply, in writing, within a time line as prescribed
(usually 15 days) or request an extension and provide
justification for request

Form 483s and warning letters are public information. Form

483s are difficult to obtain quickly and one has to know that it
exists to request it. Adversely, Warning Letters are published
upon issuance and promptly posted on http://www.fda.gov.

What is a Warning Letter?

One way that the Food and Drug Administration (FDA) protects
public health and ensures compliance with the Food, Drug and
Cosmetic Act is by conducting inspections of clinical trial
investigators, clinical trial sponsors, Institutional Review Boards
(IRB) and facilities that manufacture, process or pack FDA-
regulated products.  At the conclusion of an investigation, a site
may be issued a Form 483 or a Warning Letter. Read on to learn
the differences and similarities of these forms of communication
provided by the FDA to the inspection site.

One mechanism used by the FDA for ensuring compliance is the

inspections process run under FDA’s Bioresearch Monitoring
(BIMO) Program. If an inspection reveals significant
deficiencies the agency may issue a Warning Letter (WL) that
details the findings and specifically cites the deficiencies and
violations. These WLs are published online at the FDA website.
This online database of WLs is a useful window into the
Agency’s thinking on issues of compliance.

Role of the Investigator during the Inspection

 Ensure the availability of staff during the inspection

 Alert other staff members of inspection, so that they know
to avoid remaining in areas hosting the inspection and to
watch conversations near areas where inspectors are
present
  Ensure the availability of study-related records and provide
copies to HA as requested
 Answer questions regarding your role and the conduct of
the study
 At the end of each day, request a summary from the HA
Inspector regarding any issues identified and requests to be
fulfilled.
 Forward summary to the Alliance SPoC and the appropriate
study email at the Alliance
 Respond to any inspection findings, as required
 Site Inspection Focus (FDA)
 Site Management
 PI Oversight
 Data
 Investigational Product Management
 Adverse Events

CONSIDERATIONS BEFORE REQUESTING A BIMO

INSPECTION
A.Who is responsible for initiating a BIMO request?
ONADE initiates the BIMO inspection process for Directed
inspections and in certain cases for
For Cause inspections. Scientific reviewers or members of the
Quality Assurance Team (HFV-184) in ONADE determine the
need for an inspection of safety, effectiveness or bioequivalence
studies.
B.When in the review process should a BIMO inspection
request be initiated?
A BIMO inspection can be requested at any time before or after
approval of a new animal drug. Typically, ONADE initiates
BIMO inspections during the phased review process (See
Guidance for Industry #132 Administrative Applications and the
Phased Review Process) of a generic investigational new animal
drug (JINAD) file or investigational new animal drug file
(INAD).
Typically, there are two times ONADE requests a BIMO
inspection.
1. During the conduct of the study (real-time [also known as in-
life inspection]), and
2. After the study has been completed (data audit).
A real-time inspection allows us to observe certain aspects of
the study as they are being conducted or to look for particular
issues of concern to the reviewer.
A data audit inspection allows for a full accounting of the study,
and may be conducted before or after the data are submitted to
CVM. Either type of inspection is acceptable based on the
information needs of the reviewer. ONADE should request an
inspection as early as possible to allow sufficient time to
schedule the inspection, especially if it will be an inspection
outside the United States (a.k.a., foreign inspection).
ONADE reviewers can use the information provided in a notice
of claimed investigational exemption (NCIE, is also called a
“drug shipment notice”) to plan the BIMO inspections (see P&P
1243.4066 for more information on NCIE). Alternatively,
ONADE can request a BIMO inspection when we receive the
study data for review if the start of the study is unknown or
there is more benefit to inspecting a study after it is completed.