Insert lead inspector’s
competent authority logo /
emblem
GCP INSPECTION REPORT [insert EMA inspection
reference number] at sponsor 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 sponsor site
Page 2/21
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. Authorisation/approvals of the trial ........................................................ 8
5. Trial essential documents/Trial Master File (TMF) .................................. 8
6. Conduct and management of the trial...................................................... 9
7. Data management, statistics and reporting ............................................. 9
7.1. Data management ................................................................................................ 9
7.2. Statistics ........................................................................................................... 10
7.3. Reporting .......................................................................................................... 10
8. Documentation and reporting of efficacy data ....................................... 10
9. Documentation and reporting of safety data ......................................... 11
10. Investigational medicinal product(s) .................................................. 11
11. Laboratories, technical departments, other vendors ........................... 12
12. Quality management system ............................................................... 12
12.1. Standard Operating Procedures (SOPs) ............................................................... 12
12.2. Quality control ................................................................................................. 12
12.3. Quality assurance ............................................................................................. 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 ..................................................................... 19
GCP INSPECTION REPORT [insert EMA inspection reference number] at sponsor site
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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]
Number of sites inspected
[insert number of inspected sites]
Site details
[insert]
Address
Key data from site inspected
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]
GCP INSPECTION REPORT [insert EMA inspection reference number] at sponsor site
Page 5/21
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 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]

CPMP/ICH/137/95 “Note for Guidance on Structure and Content of Clinical Study Reports”,
July 1996

CPMP/ICH/363/96 “Note for Guidance on Statistical Principles for Clinical Trials”, September 1998
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
GCP INSPECTION REPORT [insert EMA inspection reference number] at sponsor site
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Major (MA)
data.
Major observations are serious deficiencies and
Possible consequences
are direct violations of GCP principles.
Data may be rejected and/or legal
required.
Remark
Observations classified as major, may include a
action
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
[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.
Characteristics of facilities used for the safe storage of archiving of trial documents, storage of IMPs if
applicable, computerised systems used for the clinical trial (planning, monitoring, randomisation/IVRS
GCP INSPECTION REPORT [insert EMA inspection reference number] at sponsor site
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systems, management of trial related AEs/SAEs, eCRF, data management, statistics and medical
writing), validation and maintenance of the systems,…
Describe briefly the organisation at the inspected site, contracting out of trial-related duties, if
applicable attach a list of CROs/Vendors with the duties taken for the trial(s).
Describe/list observations related to:
Qualification (education, experience and training) of sponsor/CRO personnel involved,…
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. Authorisation/approvals 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 Application/Notification to Competent Authority, contacts with the
Independent Ethics Committee (IEC), Contacts with other Committees, any other Validation or
Authorisation
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
5. Trial essential documents/Trial Master File (TMF)
Text
Describe/list observations related to:
Protocol, protocol amendments, investigator’s brochure, Case Report Forms, diaries/questionnaires if
applicable, information given to trial subject (ICF/other), insurance, PIS/Consent form,
randomisation/IVRS/breaking code system, laboratories/ technical departments, correspondence, other
essential documents of the trial,…
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Describe/list observations related to contracts with investigator sites, contracts with CROs, vendors or
consultants
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 and management of the trial
Text
Describe briefly: Set up of the trial, delegation of duties and functions, investigator selection and
training, trial coordination, study management, patient recruitment, changes in conduct, closure of
sites, protocol deviations, escalation of problems/issues and 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
Comment
Text Details
7. Data management, statistics and reporting
7.1. Data management
Text
Describe/list observations made regarding:

all steps of data handling in particular concerning the eligibility criteria, treatment (dose, regime,
incl. concomitant medication), efficacy and safety data, protocol compliance/ deviations/violations,
inconsistency of data,…

data transfers, interfaces with data systems of vendors

data monitoring committees, steering committees, any other committees involved in the trial,
members,…

data entry, data processing, edit checks, self-evident corrections, coding, reconciliation with other
(e.g. safety) databases, database freeze, database lock, data review meetings, unblinding,…
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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
7.2. Statistics
Text
Describe/list observations made regarding statistics, statistical analyses plan (SAP), Full Analyses Set,
ITT, PP population, bias,…
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
7.3. Reporting
Text
Describe/list observations made regarding reporting of data, content and structure of the clinical study
report and appendices,…
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 efficacy data
Text
Describe/list observations made regarding the eligibility criteria (selection criteria compliance),
treatment (dose, regime, incl. concomitant medication) and protocol compliance.
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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
9. Documentation and reporting of safety data
Text
Describe/list observations made in relation to recording, assessment and reporting of
AE/ADR/SAE/SAR/SUSAR to sponsor/IEC/ competent authorities/others, pharmacovigilance database,
annual safety reports, urgent safety measures, independent safety monitoring boards, role of the
medical monitor,…
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. Investigational medicinal product(s)
Text
Describe/list observations made regarding randomisation, release of batches, extension/expiry date,
relabeling, blinding, decoding/IVR(S) system; manufacturing authorisation,
labelling/packaging/reconstitution, if applicable, receipt and storage, shipments to sites, return from
sites, destruction/recovery by the sponsor, documentation or other observations in relation to the
IMP(s),…
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
GCP INSPECTION REPORT [insert EMA inspection reference number] at sponsor site
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Comment
Text Details
11. Laboratories, technical departments, other vendors
Text
Describe/list observations related to certification and accreditation, validation(s), external/internal
quality controls, analytical methods used, reference values/data, labelling, transportation and storage
of samples, results reporting and communication, data transfers, interfaces, documentation and
archiving,…
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
12. Quality management system
12.1. Standard Operating Procedures (SOPs)
Text
Describe/list observations in relation to SOPs.
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
12.2. Quality control
Describe/list observations in relation to quality control (e.g. monitoring), escalation of issues and follow
up,…
FINDING FORMATS (numbering system – x = CR1, MA1, MI1…CR2, MA2, MI2 etc):
Text Details of finding and evidence
X
Text Reference to requirement for which it is non-compliant
Text Grading – Critical/Major/Minor
Text Details of any specific CAPA requests (in addition to covering letter (see SOP INS/4)
GCP INSPECTION REPORT [insert EMA inspection reference number] at sponsor site
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X
Text Details of finding and evidence
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
12.3. Quality assurance
Describe/list observations related to quality assurance (e.g. auditing), follow up and management of
non-compliance,…
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
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.
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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 applicable
section 3.3 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
Training
Qualification of trial
personnel
Facility and equipment
Computerized systems
IMP storage
Other, specify
Archiving
arrangements and
facilities for archiving
Trial documents
Trial Master File
Maintenance
CA, IRB/IEC
Insurance
Contract(s) &
Agreement(s)
Case Report Form
Diaries, Questionnaires
PIS/CF
Investigator Brochure
Other, specify
Conduct and management of the trial
Delegation of Duties
Management of
CROs/Vendors
Medical Monitoring
Communication,
Escalation
Other, specify
Data management
Data handling/transfers
Data entry,
verification/validation
Data reconciliations
Database lock
Data review meeting(s)
Protocol Deviations
Unblinding
Committees involved in
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Extent*
Extent*
Extent*
Yes
Partial
No
Findings
(Y/N)
Details
(essential for partial/No)
evaluations
Other, specify
Statistics
SAP
Programming
Analysis
Reporting
CSR production
Quality Control
Documentation and reporting of efficacy data
Eligibility criteria
Treatment (dose,
regime, incl. concomitant
medication)
Protocol compliance
Primary end points
Documentation and reporting of safety data
Collection of SAEs
Processing of cases
Reporting to IEC/CA
Reports to Investigators
DSURs
Investigational medicinal products
Manufacturing/assembly
Importation
QP certification
Regulatory green light
Instructions for inv. site
Shipping
Accountability
Emergency decoding
Laboratories,
technical department,
other vendors
Standard Operating Procedures
QS documents
Production/control of
SOPs/documents
Non-compliance
Quality control (e.g.
monitoring)
Quality assurance
(e.g. auditing)
Other, specify
* 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.
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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/CRO
Date responses received by the inspector: insert date DD/MMM/YYYY
Attach the document received from the sponsor/CRO/applicant
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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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