Regulatory inspections are important to evaluate clinical trial data integrity and patient safety. Health authorities like the FDA and EMA may conduct inspections whenever required to inspect clinical trial sites and evaluate sponsor quality systems. Inspections involve touring facilities and reviewing documents like informed consents, safety reporting, and drug administration records. Common findings include protocol noncompliance, inaccurate records, and issues with informed consent and adverse event reporting. Inspections help ensure trials are conducted properly and help improve compliance.

1. REGULATORY INSPECTIONS

2. Regulatory
inspections are
important to
evaluate the integrity
of the data
submitted to health
authorities (HAs),
protect patient
safety, and assess
adequacy of
site/sponsor quality
systems to achieve
the same.
Data of investigational drug
All the
HA’s like
US
FDA,EMA
may
conduct
inspections
whenever
required.

3. Has jurisdiction to inspect
all clinical trials. DCGI has
conducted inspections to
investigate issues, where
required.
PRE INSPECTION
ACTIVITIES
Health
authorities
Spons
or
Direct contact

4. Curriculum
vitae of
investigato
rs
Documne
ta-ion of
sponsor
oversight
Monitoring
reports

5. IN
S
P E C
TI O
N
P
R O C E S
S
1-2
Or more
depending on the
type of study
principal investigator (PI), sub-
investigators (SI), Study coordinator
(SC), radiologist, lab personnel,
pharmacist (as applicable).
Should be available during inspection.

6. The inspection generally involves a facility tour
to evaluate site infrastructure, site’s (written)
standard operation procedures, and processes
for their adequacy to conduct clinical trials.
It may include: labs (if study related lab tests were done locally), review of lab
equipments, process, calibrations, quality control methods, accreditation documents,
training and handling of study specific lab queries; radiology/other equipments used
in study, their calibration, maintenance schedule; archival-storage area for documents,
the security, pest, humidity, and fire controls; investigational drug storage-accessibility,
security, storage conditions, temperature records, thermometer calibrations, stock
checks, labeling, accountability logs; out-patient department, clinical trial facility (as
applicable).
The inspection focus is on investigator role in the study,
delegation of duties (with documentation), qualification of
site staff, ethical issues – consent process, and ethic
committee review.

7. The data review generally includes Subject history
Informed consent
Subject eligibility
Investigational drug
administration
compliance
Safety reporting
Compliance to study
procedures

8. Types of
inspection
Inspection
conduct
Notificati
on
inspectio
n Inspectio
n fees

9. N
O
T
I
F
I
C
A
T
I
O
N
I
N
S
P
E
C
T
I
O
N
In general, the sponsor of a clinical trial will be notified 4-6 weeks prior
to the proposed inspection date and asked to confirm availability. The
notification will identify the study to be inspected, if applicable, and the
proposed sites, including any investigator sites.
In relation to for cause or triggered inspections, the HPRA may
provide a shorter notice period.

10. The following information may be requested from the
inspectee prior to the inspection:
Participant status per trial site (number randomised, drop-
out rate, and number of serious adverse events reported
per site).
Copies of company standard operating procedures e.g.
(monitoring procedure, informed consent procedure,
serious adverse event reporting procedure, drug supply
management procedure).
Trial-specific documents such as a copy of the current
protocol and informed consent form, source data
verification guidelines, product handling instructions,
laboratory manual, randomisation code breaking
procedure, monitoring plans and reports.

11. Arrangements for direct access to any computerised
systems upon which trial data or essential documents are
stored
CV of principal investigator
Any other documentation deemed necessary by the
inspectors

12. I
N
S
P
E
C
T
I
O
N
C
O
N
D
U
C
T
Routine Inspections
Routine inspections are inspections carried out as part of HPRAs congoing monitoring of
GCP compliance. HPRA inspectors will perform the inspection. The duration of the
inspection and the number of inspectors present on an inspection will vary depending on
the complexity of the clinical trial and activities conducted at the site. Typically, they are
scheduled for 3-5 days.
The scope and activities examined during some of the more common types of GCP
inspections undertaken by the HPRA are outlined below:
Investigator site inspections may include:
•Communication with
the Ethics Committee
•Communication with
the Regulatory
Authority
•Other
communications
Legal and administrative aspects

13. Organisational aspects
•Management of
biological samples
•Organisation of the
documentation
•Monitoring and
auditing
Informed consent of trial participants
Review of the trial participant data
Adverse event reporting
Management of the investigational
medicinal product(s)
Other, as required

14. Common Findings
• Protocol noncompliance,
inadequate/inaccurate
records, inadequate drug
accountability, informed
consent issues, and adverse
event reporting are some of
the most common findings
observed during
inspections. In this regard, a
warning letter is issued to
the clinical investigators by
the National Regulatory
Authority (NRA). The
warning letter clearly
demonstrates that GCP
violations are unacceptable;
in case they occur,
immediate and effective
actions are expected;
principal investigator is
responsible for site’s
compliance to GCP norms
and will be held accountable
• In addition, the sponsor may be criticized for
not having identified the issues and not taking
actions, such as holding further patient
enrolment till the issues are resolved or have
improved.
• In fact, the best strategy for clinical research
associates to prepare themselves and their sites
for any type of inspections/audits is to strictly
and constantly adhere to standard operating
procedures and all applicable regulatory
guidelines. If you want something to be fulfilled,
you must control and measure

15. REFERNCES
1.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043366/
2.https://www.hilarispublisher.com/open-access/regulatory-
inspection-of-clinical-trials-2167-7689.1000e103.pdf
3.http://www.hpra.ie/homepage/medicines/regulatory-
information/clinical-trials/good-clinical-practice-(gcp)-
inspections