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Version: 5
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Approvals
Principal Author
Name: D. Skelhorn
Signature: D. Skelhorn
Date: 15/10/2014
Signature: J. Ryan
Date: 15/10/2014
NWORTH Director
Name: R.T. Woods
Date:30/10/2014
Disclaimer: Printed SOP's are considered uncontrolled. To ensure you are working with
current version always refer to the pdf version on the NWORTH website.
North Wales Organisation for Randomised Trials in Health (& Social Care) (NWORTH)
Institute of Medical & Social Care Research (IMSCaR)
Y Wern, Holyhead Road, Bangor University, Bangor, Gwynedd, LL57 2PZ
Telephone: 01248 388095
Email nworth@bangor.ac.uk
http://www.bangor.ac.uk/imscar/nworth
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DOCUMENT HISTORY
Version Effective Authorship
number date
Summary of changes
N/A
New
16/10/09
23/10/10
12/12/12
31/10/14
S. Westley, C. Bray,
M. Jones
D. Skelhorn,
M. Williams
D. Skelhorn,
M. Williams
D. Skelhorn,
M. Williams
D. Skelhorn,
M. Williams
1. Table of Contents
1. Table of Contents ................................................................................................................. 2
2. Purpose................................................................................................................................. 3
3. Scope .................................................................................................................................... 3
4. Responsibilities .................................................................................................................... 3
5. Procedure ............................................................................................................................. 3
5.1 Procedure Flow Chart ........................................................................................................ 4
5.2 The audit ............................................................................................................................ 5
5.3 Corrective action ................................................................................................................ 5
5.4 Corrective action review/ follow up................................................................................... 6
6. Training plan for SOP implementation ................................................................................ 6
7. Glossary of Terms ................................................................................................................ 7
8. References ............................................................................................................................ 7
9. Referenced SOPs ................................................................................................................. 7
10. Appendices ......................................................................................................................... 7
Appendix 1: Audit checklist ................................................................................................... 8
Appendix 2: Example of audit report...................................................................................... 9
Appendix 3: Corrective Action Request .............................................................................. 10
http://www.bangor.ac.uk/imscar/nworth
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2. Purpose
This SOP describes the internal audit process for the quality system, which takes place on a
planned basis over the course of a year.
3. Scope
The internal audits will inspect actual practice against the requirements of the SOPs. Each
auditor or audit team will prepare an audit checklist of the area to be covered. Corrective
actions may be raised following an internal or regulatory audit where non-conformances
have been observed. This SOP does not cover monitoring of clinical trials (for monitoring
see NWORTH 3.07)
4. Responsibilities
Quality Assurance officer is responsible for:
Organising internal quality audits. He / she will appoint a person or team to carry
out each audit. The lead auditor will be independent of the area being audited.
Ensuring that corrective actions are closed out in a timely fashion, within determined
close-out dates whenever possible, this is a joint responsibility with the
representative of the area being audited.
Auditor/audit team is responsible for:
Arranging a suitable time for the audit with the representative.
Reviewing the SOP and from this developing an audit checklist.
Completing the audit and audit report.
Representative is responsible for:
Cooperating with the internal auditor.
Progress corrective actions to completeness.
NWORTH team is responsible where required to cooperate with the internal auditor.
NWORTH Trials Unit Manager has the responsibility of acting as facilitator, if the
appropriate corrective action cannot be agreed between the auditor and the auditees
representative.
5. Procedure
The Quality Assurance officer will prepare and circulate the audit timetable for the
forthcoming year to NWORTH staff. Adherence to SOP requirements will be subject to
audit at least once during a 12 month period where possible.
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5.1
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Corrective
action(s)
identified?
Yes
No
Corrective action(s)
agreed & audit report
completed
Follow up corrective action(s)
Audit report
completed
Corrective
action
completed?
No
Yes
Corrective action
closed out
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5.2.2
5.2.3
5.2.4
5.2.5
5.2.6
5.2.7
The auditor or audit teams, appointed by the Quality Assurance officer, are
responsible for making arrangements with the appropriate auditees
representative in the area to be audited.
The auditor(s) will prepare an audit checklist based on the SOP to be audited
(see appendix 1).
Any findings from previous audits on that area will be reviewed to follow up
any observations and outstanding corrective actions.
Findings, positive and negative are recorded by the auditors during the audit,
on the audit checklist, which is dated to ensure traceability to the audit.
The audit findings will be discussed with the representative at the end of the
audit to ensure the auditor and representative are in agreement with the
auditors findings.
At the conclusion of the audit, an audit report (example layout appendix 2)
will be completed and will include corrective action raised during the audit
and corrective actions followed up from previous audits, as well as any
observations noted. A non-conformance should be categorised as one of the
following: critical, major or minor.
The audit report and the corrective action request should be completed and
returned to QA within 1 month of the audit. It will be circulated to the
auditees representative and the Trial Unit Manager. If any of the findings are
related to a clinical trial(s) the relevant CI will receive a copy of the report.
Critical
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Major
Minor
5.3.4 Progress of internal audits will be reported to the Trials Unit Manager and
escalated to the Operational Team and /or Executive team as appropriate
5.5
Re- audit
A re-audit can be organised by the Quality Assurance officer to determine if the corrective
actions have been effective.
If the corrective actions have not been effective, it is the responsibility of the Quality
Assurance officer to initiate further corrective actions, and to make NWORTH Management
aware of any problem preventing satisfactory corrective action being taken. These issues
may be formally raised at the Operational Team.
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7. Glossary of Terms
CI
Chief Investigator
The investigator with overall responsibility for the research.
Corrective Action
The action taken to eliminate the cause of a detected non-conformance. Corrective action is
taken to prevent recurrence.
CAR
Corrective Action Request
Form used to document non-conformance, the resulting corrective action and follow-up to
determine if the corrective action has been completed in a satisfactory manner
Internal Audit
A systematic and independent examination to determine the effectiveness of the quality
management system ensuring adherence to SOPs, Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
GCP Good Clinical Practice
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance that the data and reported results are credible
and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Non-conformance
Failure to adhere to the Quality System, required standards, policies, procedures, regulations
etc.
NWORTH
North Wales Organisation for Randomised Trials in Health (and social care)
SOP
Standard Operating Procedure
The written instructions and records of procedures agreed and adopted as standard.
8. References
ICH E6 (R1) Guide for Good Clinical Practice
9. Referenced SOPs
NWORTH Training SOP 2.01
NWORTH Monitoring SOP 3.07
10. Appendices
Appendix 1: Audit checklist
Appendix 2: Audit report
Appendix 3: Corrective Action Request.
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Page x of x
Internal audit of xx
Present Representative:
Internal auditor:
Date of audit:
Summary of findings
Include positive and negative observations
Audit report
Audit checklist and findings
Question / audit point.
Findings / comments
Complies
with SOP
Y/N
Recommendation(s)
Corrective Action(s)
(note if the non-conformance(s) are critical, major or minor)
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Critical
Date:
Major
Minor
Department / Area: ..
Representative: ....
Auditors: ..
REP Repeat problem? Yes
1. NON-CONFORMANCE
No
Signed: (Auditor)
2. CORRECTIVE ACTION (To be completed by Representative) AND ACTION TO PREVENT RECURRENCE (if
applicable):
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