Insert lead inspector’s
competent authority logo /
emblem
GCP INSPECTION REPORT [insert EMA inspection
reference number] at BE/BA 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 BE/BA site
Page 2/23
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. Clinical conduct of the trial ...................................................................... 9
6.1. Organisation of the trial and delegation of duties ...................................................... 9
6.2. Source data verification......................................................................................... 9
7. Bioanalysis ............................................................................................ 10
7.1. Apparatus, equipment, material reagents .............................................................. 10
7.2. Handling of bioanalytical samples ......................................................................... 10
7.3. Methods used .................................................................................................... 10
7.4. Method validation ............................................................................................... 11
7.5. Results.............................................................................................................. 11
8. Data management ................................................................................. 11
9. Pharmacokinetics and statistics ............................................................ 12
10. Reporting ............................................................................................ 12
11. Safety and adverse event reporting ..................................................... 13
12. Investigational Medicinal Product(s) (IMPs) ....................................... 13
13. Pathology laboratories, technical departments ................................... 13
14. Quality management system ............................................................... 14
14.1. Standard Operating Procedures (SOPs) ............................................................... 14
14.2. Quality control ................................................................................................. 14
14.3. Quality assurance ............................................................................................. 14
15. Summary, discussion and conclusions ................................................. 15
16. Date and signature(s) of lead and other inspectors, experts if applicable
.................................................................................................................. 17
17. Appendices .......................................................................................... 18
17.1. Summary of activities inspected ......................................................................... 18
17.2. Trial documentation and approvals ..................................................................... 21
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 3/23
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
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 4/23
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
[insert]
Address
Key data at 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]
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 5/23
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/EWP/QWP/1401/98, Guideline on the Investigation of Bioequivalence’, 1 August 2010

EMA/CHMP/EWP/192217/2009 ‘Guideline on Bioanalytical Method Validation’, 1 February 2012

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

[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.
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 6/23
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
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 clinic/laboratory involved in the trial and interviewed at
inspection (for example medical director, lab director, investigator(s), study nurses, CRA(s),
phlebotomists, laboratory technicians, pharmacist(s), data manager, statisticians, medical writer,
responsible persons for IMP, QA personnel, etc.); 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 study inspected
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 7/23

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 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 section15.2 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 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
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 essential documents/Trial Master File (TMF)
Text
Describe/list observations related to:
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 8/23
Protocol, protocol amendments, investigator’s brochure, Case Report Forms, information given to trial
subject (ICF/other), insurance, randomisation/breaking code system, laboratories/ technical
departments, correspondence, other essential documents of the trial,…
Describe/list observations related to contracts, 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. Clinical conduct of the trial
6.1. Organisation of the trial and delegation of duties
Text
Describe briefly: Set Up/Management of the trial, delegation of duties and functions, course of action
Describe/list observations made related to those 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
6.2. Source data verification
Text
Describe/list observations made regarding the source documents in particular concerning:

subjects information, informed consent

the eligibility criteria (selection criteria compliance)

source data verification and protocol compliance

safety data
Describe/list observations related to:

administration of the IMPs

blood sampling for bioanalysis
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 9/23

collection, processing, transfer and storage of bioanalytical samples
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. Bioanalysis
7.1. Apparatus, equipment, material reagents
Text
Describe/list observations related to the equipment used in the laboratory (e.g. pipettes, balances,
machines used for analyses, LC-/MS/MS or HPLC and used software 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
7.2. Handling of bioanalytical samples
Text
Describe/list observations related to transport, receipt, storage, etc… of bioanalytical samples
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. Methods used
Text
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 10/23
Describe findings related to the method(s) used (preparation of stock solutions, calibration and quality
control samples, preparation of subject samples for analyses) 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
7.4. Method validation
Text
Describe findings related to the validation of the method for determination of the analyte(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
Comment
Text Details
7.5. Results
Text
Describe findings related to the bioanalysis of the samples for the inspected trials, including within-run
validation.
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. Data management
Text
Describe/list observations made regarding:
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 11/23

the different steps of data handling, for example data transfers from the laboratory,…

data entry, data processing, edit checks, self-evident corrections, reconciliation with other (e.g.
safety) databases, database lock,…
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. Pharmacokinetics and statistics
Text
Describe/list observations made regarding pharmacokinetics and statistics,..
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. Reporting
Text
Describe/list observations made regarding reporting of data, content and structure of the clinical study
report and appendices (also method validation report, analytical report), 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
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 12/23
Comment
Text Details
11. Safety and adverse event reporting
Text
Describe/list observations made in relation to recording, assessment and reporting of
AE/ADR/SAE/SAR/SUSAR to sponsor/IEC/ competent authorities/others, urgent safety measures, 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
12. Investigational Medicinal Product(s) (IMPs)
Text
Describe/list observations made regarding randomisation, release of batches, extension/expiry date,
relabeling, blinding, decoding; manufacturing authorisation, labelling/packaging/reconstitution, if
applicable, dispensing, receipt and storage, drug accountability, 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
Comment
Text Details
13. Pathology laboratories, technical departments
Text
Describe/list observations related to certification and accreditation, results reporting and
communication, data transfers, interfaces, documentation and archiving,…
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 BE/BA site
Page 13/23
X
Text Details of finding and evidence
Text Responsibility – Sponsor, investigator or sponsor and investigator
Comment
Text Details
14. Quality management system
If needed separate the subsection into clinic and laboratory.
14.1. 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
14.2. Quality control
Text
Describe/list observations in relation to quality control (e.g. monitoring), escalation of issues and follow
up,…
CAVE: Observations with regard to ‘quality control samples’ from the bioanalytical part are not to be
describe/list here. Those are to be described/listed in the respective sections ‘methods’, ‘method
validation’ or ‘results’
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
14.3. Quality assurance
Text
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 14/23
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
15. 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.

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 study 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 reporter 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 study
[Discuss if the findings are process related and not site specific, and thus relevant for the overall
clinical trial or clinical development programme.]
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 15/23
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].
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 16/23
16. 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
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 17/23
17. Appendices
17.1. 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 and equipment
Clinical areas
Computerized systems
Sample taking and
management in clinic
Other, specify
Archiving
arrangements and
facilities for archiving
Trial documents
Trial Master File
maintenance
CA, IRB/IEC
Insurance
Contract(s) &
agreement(s)
Protocol & amendments
Case report form
PIS/ICF
Investigator brochure,
SPC
Other, specify
Conduct and management of the trial
Management of
CROs/vendors, if
applicable
Trial management.
communication,
escalation
Other, specify
Clinical data
SDV subj.
information/ICF
for pat. nos.:
SDV performed for pat.
nos.:
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 18/23
Extent*
Extent*
Extent*
Yes
Partial
No
Findings
(Y/N)
Details
(essential for
partial/No)
Other, specify
Bioanalysis
Apparatus, equipment,
material, reagents
Handling of samples
Method(s) used
Method validation (s)
Results
runs/batches verified:
Other, specify
Data management
Data entry, verification/
validation
Data handling/transfers
Other, specify:
Pharmacokinetics
Statistics
Reporting
CSR production, quality
control
Safety and adverse
reporting
Investigational Medicinal Product(s)/Pharmacy
Shipping, transport
Accountability
Storage
Dispensing/administration
Randomisation/
breaking code system
Laboratories, technical
departments, other
vendors
Standard Operating
Procedures
Clinic & laboratory
Quality control
(e.g. QCs in general,
monitoring)
Clinic & laboratory
Quality assurance
(e.g. auditing)
Clinic & laboratory
Other, specify
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 19/23
* 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
auditing done…
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 20/23
17.2. 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:
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 21/23
Addendum 1: Response from sponsor/CRO
Date responses received by the inspector: insert date DD/MMM/YYYY
Attach the document received from the sponsor/applicant/investigator.
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 22/23
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 15 above.
Version: Insert DD/MMM/YYYY
Insert text
Date
Print name
Function
Signature
Date
Print name
Function
Signature
GCP INSPECTION REPORT [insert EMA inspection reference number] at BE/BA site
Page 23/23