Insert lead inspector’s
competent authority logo /
emblem
GCP INSPECTION REPORT [insert EMA inspection
reference number] at investigator site
On behalf of the European Medicines Agency
Insert name of the competent authority of LI
Inspector in charge of this inspection report
Name:
[Insert details]
Position:
[Insert details]
Address:
[Insert details]
Tel:
[Insert details]
Email:
[Insert details]
[Insert EMA inspection reference number]
[Insert CA inspection reference number]
[Insert site name, identification or abbreviation and type]
Final Inspection report: [Insert dd.mmm.yyyy]
Responses to final inspection report: [Dated as per Addendum 1 dd.mmm.yyyy]
Evaluation of inspection responses: [Dated as per Addendum 2 dd.mmm.yyyy]
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
E-mail info@ema.europa.eu Website www.ema.europa.eu
An agency of the European Union
© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
This inspection report may only be reproduced in its entirely and must not be circulated or published
without the European Medicines Agency’s consent, nor may any additions be made to the report.
GCP INSPECTION REPORT [insert EMA inspection reference number] at investigator
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Table of contents
1. Administrative information ...................................................................... 5
2. Background and general information....................................................... 6
2.1. Reason and cause for the inspection ....................................................................... 6
2.2. Reference texts .................................................................................................... 6
2.3. Grading of findings ............................................................................................... 6
2.4. List of persons involved in the trial and contacted during the inspection ...................... 7
3. Personnel, facilities and equipment ......................................................... 7
4. Administrative aspects of the trial ........................................................... 8
4.1. Application / notification to competent authority....................................................... 8
4.2. Contacts with the independent ethics committee (IEC) .............................................. 8
4.3. Contacts with other committees, any other validation or authorisation ........................ 9
4.4. Contract(s), agreement(s) ..................................................................................... 9
5. Trial documents ....................................................................................... 9
6. Conduct of the trial ................................................................................ 10
7. Documentation and reporting of efficacy data ....................................... 11
8. Documentation and reporting of safety data ......................................... 11
9. Investigational Medicinal Product(s) (IMPs) ......................................... 11
10. Data handling ...................................................................................... 12
11. Laboratories, technical departments ................................................... 12
12. Monitoring and auditing ...................................................................... 13
13. Summary, discussion and conclusions ................................................. 13
14. Date and signature(s) of lead and other inspectors, experts if applicable
.................................................................................................................. 15
15. Appendices .......................................................................................... 16
15.1. Summary of activities inspected ......................................................................... 16
15.2. Trial documentation and approvals ..................................................................... 18
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Abbreviations
[Review and amend list as necessary]
ADR
adverse drug reaction
AE
adverse event
CA
competent authority
CAPA
corrective action preventive action
CHMP
Committee for Medicinal Products for Human Use
CRA
clinical research associate
(e)CRF (electronic) case report form
CRO
contract research organisation
CTM
clinical trial manager
CSR
clinical study report
IB
investigator’s brochure
ICF
informed consent form
ICH
International Conference on Harmonisation
(I)EC
(Independent) Ethics Committee
IMP
investigational medicinal product
IR
inspection report
IVRS
interactive voice response system
IWRS
interactive web response system
MAA
marketing authorisation application
MVR
monitoring visit report
PIS
patient information sheet
QA
quality assurance
RA
regulatory authority
SAE
serious adverse event
SAR
serious adverse reaction
SOP
standard operating procedure
SUSAR suspected unexpected serious adverse reaction
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1. Administrative information
Investigational Medicinal Product(s)
Product(s):
[name; active ingredient (INN); batch number]
Application
EMA reference number:
[insert]
Name and full address of the applicant:
[insert]
Clinical trial
EudraCT number
[insert]
Sponsor
[insert name and full address]
Trial protocol code
[insert]
Trial protocol title
[insert]
Number of investigator sites
[insert total number of sites in trial]
Number of subjects
[insert total number of trial subjects recruited]
Site details
Principal investigator
[insert]
Address
[insert]
Key data from site inspected
Number of subjects at this site
[insert]
First patient first visit
[insert]
Last patient last visit
[insert]
Screened
[insert]
Randomised
[insert]
Withdrawals/drop outs
[insert]
Clinical trial report
[insert]
Dates of inspection
[insert]
Inspection Team
Authority
Country
Reporting Inspector (RI)
[insert]
[insert]
Lead Inspector (LI)
[insert]
[insert]
Inspector (I)
[insert]
[insert]
Expert (E)
[insert]
[insert]
Observer (P)
[insert]
[insert]
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2. Background and general information
2.1. Reason and cause for the inspection
Text
[Include short paragraph describing the reason and scope of the inspection, but not a copy of the
notification letter with the list of items]
2.2. Reference texts
[Review the following list and amend as necessary and consider the versions valid during the conduct
of clinical trial]

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001

Directive 2001/83/EC as amended by Directive 2003/63/EC of 25 June 2003

Directive 2005/28/EC of the European Commission of 8 April 2005

CPMP/ICH/135/95 ‘Note for Guidance on Good Clinical Practice’, July 1996

World Medical Association Declaration of Helsinki, in the version, [Insert applicable respective
Version]

GMP, Annex 13 Manufacture of investigational medicinal products, [insert applicable respective
Version]

[Insert any Local law(s) and regulations]
2.3. Grading of findings
Critical (CR)
Definition
Conditions, practices or processes that adversely
affect the rights, safety or wellbeing of the
subjects and/or the quality and integrity of data.
Critical observations are considered totally
unacceptable.
Possible consequences
Rejection of data and/or legal action required.
Remark
Observation classified as critical may include a
pattern of deviations classified as major, bad
quality of the data and/or absence of source
documents. Manipulation and intentional
misrepresentation of data belong to this group.
Major (MA)
Definition
Conditions, practices or processes that might
adversely affect the rights, safety or wellbeing of
the subjects and/or the quality and integrity of
data.
Major observations are serious deficiencies and
are direct violations of GCP principles.
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Major (MA)
Possible consequences
Data may
required.
be
rejected
and/or
legal
action
Remark
Observations classified as major, may include a
pattern of deviations and/or numerous minor
observations.
Minor (MI)
Definition
Conditions, practices or processes that would not
be expected to adversely affect the rights, safety
or wellbeing of the subjects and/or the quality and
integrity of data.
Possible consequences
Observations classified as minor, indicate the
need for improvement of conditions, practices and
processes.
Remark
Many minor observations might indicate a bad
quality and the sum might be equal to a major
finding with its consequences.
Comments:
The observations might lead to suggestions on
Definition
how to improve quality or reduce the potential for
a deviation to occur in the future.
2.4. List of persons involved in the trial and contacted during the
inspection
Text
[For investigator trials: Include a section listing the investigator(s), nurses and other key personnel
involved in the trial and interviewed, as well as sponsor personnel available at inspection (for example
QA personnel, CRAs); section may be replaced by a scanned copy of the list of attendees with below
mentioned details completed during the inspection put in the appendices]
For sponsor trials: Include a section listing the key personnel of sponsor/CRO involved in the trial and
interviewed at inspection (for example study director, medical monitor, study manager, lead CRA,
CRA(s), data manager, statisticians, medical writer, responsible persons for IMP, drug safety, QA
personnel); section may be replaced by a scanned copy of the list of attendees with below mentioned
details completed during the inspection put in the appendices.
Full name
Job title
Role in the trial inspected
3. Personnel, facilities and equipment
Text
Describe/list observations related to:
Equipment used for the characteristics of the trial inspected.
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Characteristics of facilities used for the safe storage of IMP, samples etc. and for storage and archiving
of the clinical trial documents.
If applicable: Availability of the electronic equipment regarding clinical trials (planning, issues related
to validation of computerized systems used for the trial).
(Availability of medical equipment and/or emergency equipment in the case of phase I facilities).
Security maintenance (rescue plan).
Describe briefly the organisation at the inspected site, contracting out of trial-related duties, personnel
involved in clinical research at the inspected site, qualification of personnel involved. Describe/list
findings related to the qualification(education, experience and training) of the personnel.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, Investigator or Sponsor and Investigator
Comment
Text Details
4. Administrative aspects of the trial
Text
The Table in Appendix section 15.2 may be completed during or following the inspection to record
information necessary to support this section – it is OPTIONAL. It is provided as some reports contain
tables in this and the following section and therefore some inspectors may wish to continue to do this.
Describe/list observations related to:
4.1. Application / notification to competent authority
Text
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
4.2. Contacts with the independent ethics committee (IEC)
Text
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FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
4.3. Contacts with other committees, any other validation or authorisation
Text
Describe/list observations related to: Protection of individuals with regard to the processing of personal
data or agreement for genetic samples, or cell therapy research…
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
4.4. Contract(s), agreement(s)
Text
Describe/list observations related to contracts: e.g. sponsor/CRO with investigator, hospital, university,
etc.,…
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
5. Trial documents
Text
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The Table in Appendix 15.2 may be completed during or following the inspection to record information
necessary to support this section – it is OPTIONAL. It is provided as some reports contain tables in
this and the previous section and therefore some inspectors may wish to continue to do this.
Describe/list observations related to:
Protocol, protocol amendments, investigator’s brochure, CRF, diaries/questionnaires, , versions, receipt
of documents at inspected site, etc.
Describe/list observations related to:
signatures/delegation list, information given to trial subject (ICF/other), insurance, PIS/Consent form,
subject screening log, subject enrolment log, agreements, randomisation/IVRS/IWRS/breaking code
system, laboratories/technical departments, correspondence.
Availability of applicable essential trial documents
Findings in responsibility of the sponsor, CRO respectively, related to trial documents to be listed here
as well.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
6. Conduct of the trial
Text
For investigator inspections, describe briefly:
- Set up of the trial, distribution of duties and functions,
- subject recruitment, screening, informed consent process, confidentiality of the subjects,
- inclusion, examinations, assessments,
- follow up.
Describe/list observations related to these aspects.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
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Comment
Text Details
7. Documentation and reporting of efficacy data
Text
Describe/list observations made regarding the source documents in particular concerning: the eligibility
criteria (selection criteria compliance), treatment (dose, regime, incl. concomitant medication), source
data verification and protocol compliance.
Describe issues regarding the consistency of data (e.g. when comparing data listings from the CSR
with source documents). (Please note: observations made concerning the procedures, i.e. the informed
consent procedure, the screening process, etc. should be described in Section 6).
Findings in responsibility of the sponsor, CRO respectively, related to data management, data handling
or reporting to be described/ listed here as well.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, Investigator or Sponsor and Investigator
Comment
Text Details
8. Documentation and reporting of safety data
Text
For investigator site inspections, describe/list observations made in relation to recording, assessment
and reporting of AE/ADR/SAE/SAR/SUSAR to sponsor/IEC/ competent authorities/others.

Availability of safety information (line listings, Dear Dr. Safety letters, Investigator Brochure, etc.).

Urgent Safety Measures compliance, if any.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
9. Investigational Medicinal Product(s) (IMPs)
Text
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Describe/list observations made regarding:

receipt and storage, temperature records control (if +2+8°C or - 20 °C) dispensing, administration
to trial subjects documentation,

accountability of the pharmacy/investigators site, compliance, returns from clinical site /trial
subjects, destruction/recovery by the sponsor,

allocation of treatment, randomisation, decoding/IVR/IWRS system, documentation on decoding,

manufacturing authorisation, labelling/packaging/reconstitution, extension/expiry date, relabeling
if applicable.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
10. Data handling
Text
Describe/list observations made regarding data management, statistics and reporting of data, as
appropriate
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
11. Laboratories, technical departments
Text
Describe/list observations related to certification and accreditation (see also section 4),
external/internal quality control programme, analytical methods used, reference values/data, labelling,
transportation and storage of samples, results reporting and communication, documentation and
archiving, validation.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
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Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
12. Monitoring and auditing
Text
Summarise monitoring visits and procedures used, actions taken by the monitor, escalation/follow up
by monitor, monitor visit log and management of non-compliance.
Describe/list observations related to monitoring and monitoring follow up and whether there was an
impact on the data quality.
Describe/list observations related to auditing – confirm if site has been audited and when.
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
Text Reference to requirement for which it is non-compliant
X
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
13. Summary, discussion and conclusions
Summary and Discussion
Text

Provide the scope of the inspection and describe what was actually inspected (very short).

Quantitative result of the inspection: number and grading of the findings (e.g. X critical findings, Y
major findings and Z minor findings) were observed.

Summary and evaluation of critical and major findings.

Findings with impact on the trial and the marketing authorisation application should be separately
presented from findings with a systematic nature or which are process-related. Refer to “Points to
consider on good-clinical-practice inspection findings and the benefit-risk balance” where
appropriate.

Ethical issues to be listed separately (e.g. vulnerable population, trial conducted in a third country
without local IEC and/or CA), if any.
Overall conclusion
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Text

Statement on GCP compliance and whether the trial was conducted in accordance with
internationally accepted ethical standards.

Statement on validity/reliability of data (specify trial data which are affected by findings, as
appropriate).

Describe impact of findings on overall trial data, as appropriate.
Important – this section will be completed prior to receipt of any responses from the
sponsor/applicant/investigator. If conclusions cannot be drawn until then, then state this clearly. The
evaluation and conclusions can be then addressed in Addendum 2 to the reporte once the responses
have been evaluated. Where this is a single site inspection and the IR serves as the IIR, then
Addendum 2 should follow the requirements of the IIR and be written with section headings as follows:
Conclusions from inspection findings
Assessment of the relevance of the findings for the full trial
[Discuss if the findings are process related and not site specific, and thus relevant for the overall
clinical trial or clinical development programme.]
Quality of the data and GCP compliance
[Discuss the implication of any major or critical findings on data quality {cross reference to relevant
section or the IRs} and compliance with the GCP principles. This section may need to be specific on
which data were affected and to what extent. The section may need to discuss the results of any
responses by the inspectee/ sponsor that are re analyses (extrapolations/sensitivity)]
Recommendation for the acceptability of the clinical trial data
[Provide a conclusion on whether the quality of the data inspected as a whole or in parts may be used
for the evaluation by the assessors regarding acceptance/non-acceptance of the trial data.]
Recommendations for follow up actions (GCP Systems)
[Provide a conclusion and recommendation for any further actions regarding CAPA and re-inspection,
for example, must inspect further MAA applications involving inspected organisations, in respect of any
GCP system findings]
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14. Date and signature(s) of lead and other inspectors,
experts if applicable
Date
Print name
Function
Signature
Date
Print name
Function
Signature
Date
Print name
Function
Signature
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15. Appendices
15.1. Summary of activities inspected
(Please enter, which areas where inspected during the inspection, if necessary enter details or specify).
Extent*
Yes
Extent*
Partial
Extent*
Findings
No
(Y/N)
Details
(essential for
partial/No)
Personnel involved in trial
Protocol and GCP
training & qualifications
Interviews with key
personnel
Delegation of duties &
specimen signatures
Facility review
Clinical areas
Laboratories
Technical departments
Pharmacy
Technical equipment
(calibration and
maintenance etc.)
Archiving
arrangements and
facilities for archiving
Investigator TMF review
Contract(s) &
agreement(s),
Institutional
correspondence/approval
Protocol & amendments
IEC/IRB
opinions/communication
Regulatory
approval/communication
IB
PIS/ICF
Insurance
Subject screening &
enrolment log
Contacts with other
committees, other
validation(s) or
authorisation(s)
Informed consent
Process and completed
documentation
Conduct of the trial
Protocol & GCP
compliance
Documentation and
reporting of data
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Extent*
Extent*
Extent*
Yes
Partial
No
Findings
(Y/N)
Details
(essential for
partial/No)
(Safety data)
SDV performed for pat.
nos.:
Documentation and
reporting of data
(Efficacy data)
SDV performed for pat.
nos.:
Documentation and
reporting of data (CRF
design, functionality,
independent copy on site
etc.)
Pharmacy file
review/investigationa
l medicinal
product(s),
administration,
compliance, handling
randomisation/IVRS,
breaking code system
Monitoring and
auditing
Other (state)
* Yes – this means an assessment of this area was undertaken that was considered sufficient by the
inspector to make an assessment of compliance and identify any issues.
Partial – this means that a limited assessment of the area was undertaken – for example time
restrictions prevented the full assessment – there may be undetected issues.
No – this area was not looked at. This could be because it wasn’t necessary to address the scope of
the inspection or answer any concerns/questions in the inspection request.
A comment should be provided, this could be because it was not applicable – for example there was no
laboratory involved in the trial, no IVRS system, etc.
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15.2. Trial documentation and approvals
(OPTIONAL TO COMPLETE)
APPROVAL DATES
SUBMISSION
Substantial
IEC/
Sponsor
Investigator
Any other
Protocol
Subject
Other
INITIATION/
IRB
approval
approval (if
required
version
information and
documents
IMPLEMENTATION
substantial
(if
applicable)
approvals
(NS)
applicable)
(S) / Non-
CA
DOCUMENT VERSIONS
consent form
DATE
version /date
Initial
Date:
#2
Date:
#3
Date:
#4
Date:
#5
Date:
#6
Date:
#7
Date:
#8
Date:
#9
Date:
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Addendum 1: Response from sponsor/applicant/investigator
Date responses received by the inspector: insert date DD/MMM/YYYY
Attach the document received from the sponsor/applicant/investigator.
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Addendum 2: Evaluation by the inspectors of the response
This summary should be prepared by the Lead Inspector and signed by all the inspectors. If the IR is
to serve as the IIR as it is a single site inspection, then the sections should follow the IIR as outlined in
section 13 above.
Version: Insert DD/MMM/YYYY
Insert text
Date
Print name
Function
Signature
Date
Print name
Function
Signature
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