QS01-H Internal Audits V01 en Outdated

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QS01-H

Internal Audits

Version: F01 Valid from:

Replaces version: -- of: --

Author: Edith Belz _________________ ___________________Date Author signature

Review: FG-QM _________________ ___________________Date FG-QS

Approval:Board KKS Network _________________ ___________________

Date Board spokesperson

Target group: All Coordination Centres for Clinical Trials

Appendixes: QS01-H-A1 Audit typesQS01-H-A2 Annual audit scheduleQS01-H-A3 Audit planQS01-H-A4 Evaluation of audit findings

Note:Italic text in this SOP is not to be adopted word for word in the local version; it is to bereplaced by the corresponding local information.

This English translation is based on a German document which has been developed in line with theharmonisation procedure for the creation of Standard Operating Procedures for Clinical Trials (SOP) asdescribed in SOP "GE01". The German version has been adopted by many German Research Institutionswhich focus on Investigator Initiated Trials (IIT), in particular the member organisations of KKSN (www.kks-netzwerk.de) and TMF (www.tmf-ev.de).

This English translation is meant for facilitating the creation and adoption of Standard Operating Procedures inmultinational clinical trials. Please note: Not every German SOP document was eligible for translation, thus the set of English translations is NOT

COMPLETE. Updating of English translations does not follow the same update cycle as for the German originals, so some

English versions might be OUTDATED compared to the German versions. The respective files are flaggedwith an "outdated" suffix in their file name. Surely these versions are still useful and therefore downloadableon TMF website.

© License condition and copyright: This work, including all of its parts, is protected bycopyright. The rights belong to TMF unless otherwise indicated. TMF is unable to give aguarantee with regard to the accuracy of content. Reproduction and transmission are solelypermitted within your organization or company as well as TMF membership unless otherwiseagreed with TMF. For reasons of quality assurance and transparency with regard to

dissemination and use of the TMF results any further dissemination will solely take place via the TMF website or

the TMF Office.This work has been developed as work material, which is why changes may be made to printouts or renamedcopies of the original file inasmuch as they are suitably marked to avoid confusion with the original document.The conditions of use and the TMF logo may be removed from the changed copies. TMF recommendsalways keeping the printed original document or the write-protected original file available for reference.Reproduction and transmission of changed versions is solely permitted within your organization or company aswell as TMF membership unless otherwise agreed with TMF.Inasmuch as changed copies or documents created by yourself with the aid of this work are used in practice,they should be sent to the TMF Office by email (info@tmf ev.de) to the extent not precluded by legal regulationsor contractual obligations (including those toward third parties). These documents sent will be used by TMFsolely for the purpose of further developing and improving TMF results and will not be published.



QS01-H Internal Audits V01 F

ContentsPage

1. Objective....................................................................................................................32. Background................................................................................................................3

2.1 Types of audits at KKS....................................................................................3

3. Processes.................................................................................................................. 43.1 Forms of internal audit ...................................................................................43.2 Planning internal audits...................................................................................43.3 Performing audits............................................................................................63.3.1 Contents of system audits ..........................................................................63.3.2 Contents of trial audits................................................................................73.3.3 Content of product audits ..........................................................................93.3.4 Contents of a procedural audit ...................................................................93.4 Conclusion of the audit .................................................................................103.5 Reference documents for auditors during the audit.......................................103.6 Audit documentation.....................................................................................113.6.1 Auditor report for an internal system audit done by a third party.........................13

3.6.2 Audit report of an on-site audit .................................................................133.6.3 Audit report for an internal system or process audit .................................143.7 Evaluation of audit findings...........................................................................14

4. References...............................................................................................................155. Changes from last version........................................................................................15

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1. Objective

The objective of this SOP is to establish a quality standard for KKS for internal audits.

This SOP refers to clinical trials on medicinal products but can also be used for trials that arenot governed by the AMG.

2. Background

According to the ICH-GCP Guideline E6 (5.1.1), every sponsor responsible for a clinical trialis required to provide independent quality assurance by means of audits. According to ICH-GCP Guideline E6 (5.19), an audit determines whether trial-related activities are beingcarried out in accordance with the applicable legal provisions and GCP, according to theprotocol and the valid SOPs, and whether documents are being properly drafted.

DIN EN ISO 9000 describes guidelines for quality management systems and establishes theterminology for quality management systems including audits. DIN EN ISO 19011 can be

used as a reference for planning and performing audits.

Internal audits determine the maintenance and applicability of a facility’s own provisions andregulations, and are primarily a tool for improvement. Internal audits ensure that the qualitymanagement system is maintained and developed. Deviations from the requirements arefound and potential improvements are identified, and measures for correction andimprovement are monitored. This SOP therefore regulates the internal audit process.

Auditor Auditors may not audit their own area of responsibility (objectivity). The management of theKKS generally appoints suitable employees as auditors, if necessary, in collaboration withQMB. ICH-GCP 5.19.2 provides instructions on the selection and qualification of auditors.The sponsor is responsible for selecting the auditor.

Reviewer In contrast to an audit (independent quality assurance), the person responsible for a reviewis not independent of the clinical trial (in-process quality control). In reviews, personsinvolved in clinical trials check whether a document from their clinical trial (such as the CRF,or the trial protocol) is practical, implementable, and observes the formalities from their perspective of his responsibilities. The formal audit procedure does not have to be observed.

2.1 Types of audits at KKS

a) System audits are generally for investigating whether a new trial site or acorresponding facility is suitable for participating in a clinical trial. System audits arealso for reviewing the overall quality management system at KKS or its individualareas. System audits for suitability testing of an trial site or corresponding facilityshould preferably be done at the beginning of a clinical trial. System audits can also beperformed at any other time in a clinical trial. System audits can be comprehensiveand deal with the entire (quality management) system or parts (procedural audits), or individual system processes.

b) On-site audits are a type of system audit. On-site audits are normally performed by theinvestigator in the presence of the relevant monitor. Ideally, on-site audits are carried

out after the first trial subject are included and initially monitored. If systematic errorsare discovered at the time of the audit, they can be corrected in a timely manner, andthe clinical trial can continue.

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c) A product audit assesses the agreement between the process of production with thequality requirements of the end product after final testing. In product audits, theprotocol or CRF, for example, of a clinical trial is audited. Product audits are performedbefore submitting the documents of a clinical trial to the competent ethics committee or authorities.

d) Process audits check whether the employees are using the KKS SOPs, and if theemployees find them practical and still relevant. Process audits are usually notperformed; instead, system audits that include process audits are usually carried out.

These terms identifying the types of audits should be used in the documentation of audits at KKS. The type of audits must be given in the audit report under the heading“Basis for the audit”.

The general types of audits are defined in Appendix 1.

3. Processes

3.1 Forms of internal audit

a) Audits for internal quality assuranceInternal audits should be scheduled at least annually and systematicallyperformed at KKS to ensure quality assurance according to ICH-GCP.

QMB, KKSmanagement

b) Audits as sponsor The KKS can assume responsibilities on behalf of the sponsor for clinical trial activities provided this is agreed in advance (e.g. by contractor authorisation).

If a system audit or on-site audit is performed for the hospital or university as the sponsor, it must first be determined if the trial site hasreceived the audit report (see 3.5.2, last paragraph). Likewise, it must bedetermined if the trial site will be given an opportunity to comment on thedraft of the audit report. If this is the case, the comments will become apart of the audit report. The auditor will then draft the audit report, send itto the trial site, and ask for comments by a certain date. The auditor will

ensure that the deadline is adhered to, and is also responsible for preparing the audit report within an appropriate period (approximately 4weeks for an audit report with comments; approximately 2 weeks for anaudit report without comments). The recipient of the final audit report willbe specified by contract, and the contract will also determine whether the trial site will receive only a letter of thanks or this and an auditcertificate. The original audit certificate will be filed in the sponsor’s TMF.

During product audits, the person preparing the correspondingdocument (such as the CRF) must be given the audit report. This mustbe agreed on in advance.

KKSManagement

3.2 Planning internal audits

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a) Annual audit schedule for internal quality assurance audits An annual audit schedule (Appendix 2) is normally prepared at thebeginning of the year. In this audit schedule, the audits of theareas/departments/facilities are distributed over the months of the year.The annual audit schedule prepared and signed by the QMB ispresented for approval to the management of KKS. The annual audit

schedule includes the main reasons (“Basis for the audit”) for theplanned audit such as the observance of SOPs, on-site audit, or XYclinical trials.

The annual audit schedule can be supplemented or changed during theyear if requested by the management of KKS or if QMB consults withthe management of KKS.

The annual audit schedule should be announced after the employeesapprove it.

QMB, KKSmanagement

b) Audit plan (audit schedule, audit process plan)

The auditors and any associated experts will be identified or appointedby QMB itself or together with the management of KKS at the latestduring audit planning. The QMB can function as the auditor. Auditorsmay not audit their own project (objectivity). Experts should be involvedin an audit if an auditor has to audit an area in which he or she has noexpertise. The expert may not belong to the audited area. If nosuitable auditors are found in KKS, external auditors can be appointedfor the internal audit.

QMB, KKSmanagement

In the audit plan (Appendix 3), the goal of the audit must be clearlyformulated so that the results of the audit can be clearly measured inthe audit report or an overall evaluation. Possible goals of the audit canbe: "On-site audit - The trial site is in conformance with GCP and canbe entrusted with the conduct of clinical trials," or "System audit in KKS- The applicable SOPs are observed in areas XY“. The QMB generallyclarifies the goal of the audit with the management of KKS and notifiesthe appointed auditor.

The audit plan includes the schedule and basis for the audit, andassigns a responsible party for each area or department involved. Thisperson must be available during the audits. The draft of the audit planshould be given to the audited employees approximately 2 to 4 weeksbefore the planned audit to allow the addition of persons or changes to

the schedule (this may be organizationally necessary if, for example,pharmacies or laboratories are to be included in the audits). If inexperienced auditors are assigned an audit, the QMB assists with theprocess.

Auditor, QMB

The audit determines who will be the contact during the audit (such asthe trial coordinator, person drafting of the protocol, etc.). This must beclarified beforehand depending on the type of audit.

QMB or auditor (in the

case of internal

audits with anexternal site,possibly with

KKSmanagement)

Customer consent may have to be obtained for on-site audits. This is a QMB and

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factor when for example KKS wants to audit its monitor in a clinical trial,but the trial site is not the KKS itself. The customer’s consent to anaudit must be obtained in writing; at the same time, an agreementneeds to be reached with the customer about how to handle the auditreport and whether to prepare a letter of thanks or audit certificate.

KKSmanagement

When the audit plan is submitted, the persons to be audited will benotified of their requirement to participate and be asked for anyadditional documents that may be needed such as the protocol,monitoring reports, etc. A deadline for returning the proposed changeto the audit plan will be set, and the auditor will sign the audit plan. If necessary, the responsible auditor will provide the names of other co-auditors or accompanying experts. If inexperienced auditors areassigned audits, the QMB will assist with this process.

Auditor, QMB

The finalized audit plan is given to the contact person of the area to beaudited. Contact persons must be informed that they are responsiblefor notifying all the persons and facilities that will be audited, and that

they must be available during the audit.

3.3 Performing audits

The audit commences with the introduction of the auditor. After theintroduction, the auditor briefly explains the purpose, scope and time requiredfor the audit. The audit procedure depends on the purpose as well as the trialsite, facility, area, or department to be audited. Any necessary changes to theaudit plan must be briefly determined. Furthermore, depending on the plannedscope of the audit (such as a system audit of all areas), it needs to bedetermined if each of the affected members can see the complete audit report,or if the audit report should be divided into the corresponding areas, and eachparty or area concerned will be provided with the part of the audit report thatconcerns them.

Auditor

All employees concerned should be present at the introductory discussion.The audit plan identifies who these individuals are. A reference should also bemade to the final audit discussion, which all those concerned should alsoattend.

The audit shall be carried out according to the audit plan.

In the case of external audits (on-site audits), the persons need to be identifiedwho the auditor can contact if necessary when the auditor is performing tasksby himself, such as SDV. If two auditors are performing the audit, it should bementioned in the introductory discussion at the latest that none of the auditedpersons need to be present during these phases. The auditors should havethe opportunity to discuss the progress of the audit without interference asneeded.

3.3.1 Contents of system audits

The following should be audited in system audits, which determine whether an

trial site or another facility can participate in a clinical trial:• Organizational diagrams

• Quality management manual

Auditor

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• SOPs

• Qualification and continuing education of the personnel

• Personnel workload

• Workplaces, task descriptions, job descriptions

• Computer systems

•

Technical facilities• Equipment including secure access to the investigational drug

• Emergency management

• Archiving options

• Data protection

• Documentation instructions and templates for maintaining the cold chain

(such as the centrifuge manual, refrigerator temperature logs)

System audits can also be used to review the quality management system of the KKS as a whole or its individual departments. System audits can becomprehensive, or they can deal with the (quality management) system, or

parts thereof (process audit), or individual processes. System audits at theKKS should be planned according to the individual requirements.

The topics listed can be cited in the audit plan under "Basis for the audit(subject/process)". The audit involves tours of the facilities, an inspection of documents, and interviews with responsible parties and employees.Discussions during the audit should occur at the audited employees’ workplace.

3.3.2 Contents of trial audits

Trial audits can occur at any time during a clinical trial. Ideally, on-site auditsare performed after the first patient or healthy subject has been included andthe first monitoring visit has taken place.

The trial site is normally informed of the intention to perform an auditapproximately 4 to 6 weeks before the planned deadline, first by telephone,and then shortly after this in writing. The letter to the investigator shouldinclude the date of the audit, the names of the auditors and any accompanyingexperts, an overview of the topics, and a general timeframe. The letter shouldagain inform the responsible investigator that his presence is required duringthe audit.

The auditor will inform the clinical trial monitor of the audit date in writing. Theauditor should obtain the following documents, preferably from the monitor,before the audit:

• SOPs

• Protocol including amendments

• Subject/Patient Information

• Informed Consent Declaration

• CRF

• Monitoring handbook

• Monitoring reports

• If applicable, additional documents concerning the trial such as

laboratory instructions

Auditor

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Trial site-specific documents:

• List of the staff involved in the clinical trial

• Overview of SAEs/AEs

• Overview of investigational medicinal products (drug accountability)

• List of previous monitoring visits

• If applicable: overview of randomization

In the audit of an trial site, the investigator should provide the auditor with adescription of the trial covering the following points directly after theintroductory discussion:

• The organization of the clinical trial

• The participating assistants and their jobs and responsibilities

• Methods of recruitment

• Subject/Patient Information and method of obtaining the Informed

Consent Declaration

• The recruitment rate of trial subjects

• The schedule of examinations and samples according to the protocol

• Any deviations from the protocol

• Any problems that have arisen

• The randomization procedure

• The location(s) of the protocol and its availability to the staff involved

• The investigational medicinal products procedure and storage conditions

• The procedure for reporting SAEs/AEs

• Special features of the laboratory

• Whether and how the general practitioner or any other attending

physicians (in the hospital) will be informed about the subject’s

participation in the clinical trial• The feasibility of the clinical trial with regard to workload (how many

clinical trials are being carried out, staff relieved of regular duties toperform clinical trial work, etc.)

Finally, the auditor should have the participating assistants describe their activities in the clinical trial.

Furthermore, the auditor will check the following points on site:

• Documentation in the Investigator Site File and Trial Master File (single-

centre trial)

• Documentation and reporting of SAEs/AEs

• Storage of the investigational medicinal products

• Equipment, if applicable

• Whether there are any evident deviations from the protocol

• Database

• Data protection

• Archiving

• Contracts/agreements

• Subject/Patient Information and Informed Consent Declaration

• Monitoring log

• Drug accountability

• Laboratory data – are reference ranges available• Laboratory – are interlaboratory proficiency certificates available

• Are all the necessary medical records available

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• SDV: 100% for at least one trial subject's medical records with CRF. The

number of items when performing SDV depends on the clinical trial.

In an on-site audit, the auditor should not mention findings concerning thequality of the monitor’s work during the final discussion at the general session.The auditor should not harm the reputation of the monitor as an intermediary

between the sponsor and trial site, and as the person responsible for qualitycontrol. If any such findings have been made concerning the quality of themonitor’s work, they should be discussed with the monitor personally. Usuallythe trial sites do not receive audit reports since they also include findingsconcerning the monitor. Generally speaking, the sponsor is responsible for ensuring that the monitor implements the appropriate measures for improvement and is also responsible for monitoring their implementation.

3.3.3 Content of product audits

In product audits in clinical trials, the CRF or protocol is usually audited. The

purpose of the audit is to check whether the documents prepared meet all thenecessary requirements. The requirements may be specified in the followingdocuments, or may be specifications from the following institutions:

- ICH-GCP- Directives- Laws (such as the German Drug Law, Medical Devices Law, Federal or

State Data Protection Law)- Regulatory requirements and standards for adhering to recognized

national and international standards of science and technology- Ethics committees- Authorities

- SOPs in force

The documents and specifications that are to be used must be listed in theaudit report under the heading “Basis for the audit.”

At the beginning of the audit, it must be noted that the author of the CRF or protocol is responsible for processing the findings in the audit report.

A product audit generally does not involve the interview phase (including theintroductory and final discussion). When the audit report is supplied to theauthor of a document, the author should be informed that the auditor can be

approached with any specific questions.

Auditor

3.3.4 Contents of a procedural audit

In process audits, SOPs usually form the basis of the audit. The primaryobjective of a procedural audit is to check if the SOPs at KKS are used inpractice by the employees, or if they are practical and relevant for theemployees. In addition, the audit can also serve to check if the applicableSOPs meet all the necessary requirements and contain the best methods for carrying out processes. The requirements can be generated by the followingdocuments or specifications from the following institutions:

- ICH-GCP- Directives

Auditor,QMB

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- Laws (such as the German Drug Law, Medical Devices Law, Federal or State Data Protection Law)

- Regulatory requirements and standards for adhering to recognizednational and international standards of science and technology

- Ethics committees- Authorities

It is generally best to perform this type of audit in interviews with employees.Documents should be inspected after the interview phase. The inspectionsare to demonstrate that the SOPs are being adhered to (for example in specificclinical projects).

The QMB monitors the processing of the findings in the audit report.

3.4 Conclusion of the audit

After the actual audit is over, a final discussion is held with the auditedpersons. All of the people affected by the audit should be present. This shouldbe communicated at the latest in the introductory discussion. In the finaldiscussion, positive feedback is presented in addition to information onpotential or necessary improvements. However, the auditor is not acting as aconsultant, in contrast with the monitor. The auditor's main task is to prepare awell-founded audit report for the sponsor (manager of KKS or QMB, or thesponsor). The auditor should not mention or discuss highly critical findings (for example concerning lack of conformity with GCP at the trial site) at the finalsession. Random samples are generally taken in the audit due to the timeconstraints, and the audit report should always refer to this fact. The following

formulation can be used: "Because random samples are used in an audit, it ispossible that additional problems or deviations exist which have not beenidentified by this audit."

Auditor

The QMB or individual department is responsible for specifying improvement measures emerging from internal system and process audits. If the department is responsible, it must decide how the information is to be communicated toQMB (QMB may need to be consulted) and how QMB will be informed of how the improvement measures have been implemented. If necessary, a follow-audit will be conducted.

QMB

3.5 Reference documents for auditors during the audit

Checklists can be used for the audit, such as checklists from SOPs onpreparing the trial protocol. The checklists cite topics and points that are to bedealt with. Check-off categories are provided in checklists such as ‘done’, ‘notdone’, and ‘not applicable’. The checklists are to be individually adapted to theaudited trial site or facility and the purpose of the audit. If checklists are used,they are to be archived as an audit log. The audit log serves as the basis for the audit report. All of the documents that are used for preparing andperforming the audit belong to the auditor and are to be archived by the QMB

of KKS. These documents may not be filed in the trial folders (ISF etc.) at thefacility. The audit log (surveys and checklists) can be destroyed after thefindings of the audit report have been completely processed.

Auditor

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In addition, question lists can be prepared for the audit. Question lists containspecific questions that are posed to the audited persons. Fields for theresponses are provided in the question lists. The questions lists are stored inthe same way as the checklists.

The question lists and the checklists help auditors perform audits in a

structured manner, especially those who are not so experienced. However,audits are always influenced by special aspects and considerations regardingthe institutions and persons involved, and the auditor can deviate from thequestion lists and checklists if needed in an audit.

As needed, the auditor chooses the checklists relevant for the audit from the Appendixes of the relevant SOPs, checks their applicability, and adapt them tothe situation of the clinical trial.

3.6 Audit documentation

An audit report is to be prepared after an audit. Auditor

The management of KKS will determine if an audit report by inexperienced auditors needs to be reviewed before passing it on to the department audited.The QMB (if not the auditor) or the management of KKS can review the audit report. The reviewer checks if the formulations are unambiguous and objective, there is adequate evidence to support the findings, and the content is correct.

KKSmanagement

The basic data are again listed in the audit report, brief positive feedback isprovided, and the findings are listed. Recommendations on improvements canalso be provided in audits. If the management of the KKS reviews the auditreport of inexperienced auditors, the audit log can also accompany the auditreport. This gives the management of the KKS an opportunity to support anyobservations that were not recorded in the audit report but led to a finding or recommendation in the audit report.

The findings should be evaluated. Definitions for the evaluation can be foundin Appendix 4, and should be adapted to the audit as needed. The definitionsshould accompany the audit report so that the facility audited can determinethe seriousness of the findings and the urgency of rectifying them. Reasonsfor the findings can be provided if needed. If arranged beforehand, the auditreport draft should be sent to the audited persons for their comment within 14

of the audit.

The audited facility should include a statement on the findings in thecomments, e.g. that the finding will be rectified by a particular date by aparticular person; or that the finding is not applicable for the following reasons,etc. The auditor is responsible for finalizing the audit report within anappropriate period (approximately 4 weeks for an audit report with comments;approximately 2 weeks for an audit report without comments). The auditor isresponsible for ensuring that the deadline given for the comments is adheredto.

The comments provide the auditor with information on how a facility is dealing

with the findings or plans to deal with the findings.

Auditor

If an audit certificate is provided, the findings must be evaluated. The auditor can decide whether to provide an audit certificate based on improvements in

Auditor,QMB, KKS

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(at least) the most problematic findings. If comments on the audit report aregiven to the auditor that the auditor finds unacceptable, the audit certificatewill not be issued. The auditor will communicate this fact to the audited persons and will attempt to find a solution. If necessary, the QMB or management of KKS will be asked for their input.

management

The general location where the audit certificates are filed must be indicated.The comments from the facility audited form part of the audit report. Theoriginal version of the finalized audit report is sent to the QMB/KKSmanagement/sponsor.

The employees audited can be given a copy of the audit report. Thedistribution list for the audit report should be agreed at the beginning of theaudit (interview) with the employees of KKS. If the audit takes place at anexternal location (such as an on-site audit), the distribution list for the auditreport should be determined with the persons concerned when the audit ends.

Auditor

Audit reports are to be filed with the QMB separate from the trial folders for the

clinical trial. The documents from the QMB are to be archived separately fromthe trial folders.

QMB

The audit certificates for on-site audits and product audits (protocol, CRF) areto be filed in the TMF. The original or a copy of audit certificates for on-siteaudits is also to be filed in the ISF.

Trialcoordinator

The audit certificates do not contain an evaluation of the audit, i.e., there is noproof of quality, they document only that an audit has occurred.

Auditor

If the audits are contracted out, copies of the audit certificates are created for the trial folders at the KKS and for filing at QMB when the originals for on-siteaudits or product audits are prepared by the auditors.

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3.6.1 Auditor report for an internal system audit done by a third party

The audit report of system audit conducted by a third party should contain thefollowing information:

Cover sheet:

-Goals and scope of the audit

- Sponsor - Address- Address of the person who will receive the original audit report- Distribution list of those people who will receive a copy of the audit

report- Type of audit- Period of the audit- Audited trial sites/facilities/system/subsystem

process/division/department- Basis for the audit- Auditor(s)

Subsequent pages:- General Information- Summary- List of results (depending on the purpose of the audit) = findings

including evaluations- Definition of the evaluation- Comments from the trial site/audited facility- Signature of auditor(s)

Auditor

3.6.2 Audit report of an on-site audit

The audit report of an on-site audit should include the following information:

Coversheet:- Goals and scope of the audit- Sponsor - Address- Address of the person who will receive the original audit report- Distribution list of those people who will receive a copy of the audit report- Type of audit- Period of the audit

-Title of the clinical trial including the trial design

- EudraCT No. if applicable- Code (brief trial ID) for the clinical trial- Audited trial site- Basis for the audit- Auditor(s)

Subsequent pages:- General Information- Summary- Signatures of the auditors

-List of the results on the:Personnel and organizationDevices and equipment

Auditor

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Required regulatory documentsSubject/Patient Information and Informed Consent DeclarationInvestigational medicinal productsMonitoringSAE/AE/ADRCRF, review of the trial subject files (raw data)

= findings including the evaluation- Definition of the evaluation- Comments from the trial site- Signature of the auditor(s)

The audit certificate should contain the following information:- Audited trial site- Confirmation that the audit was performed according to applicable laws

and GCP guidelines- Title of the clinical trial including the trial design- Code (brief trial ID) for the clinical trial- EudraCT No. if applicable

-Monitor responsible, if applicable

- Period of the audit- Signature of the auditor(s)

If a letter of thanks instead of an audit certificate is sent to the trial site, thesame information should be included in a letter of thanks.

3.6.3 Audit report for an internal system or process audit

The audit report for an internal system or process audit should contain thefollowing information:

Cover sheet and subsequent pages:- Audited area/process- Goals and scope of the audit- Type of the audit- Period of the audit- Responsible parties/participants (distribution list)- Findings and any additional evaluations- Summary (with positive feedback)- Improvement potential –> recommendation to KKS management

The audit report should include fields for:- A statement by KKS management on improvement potential, and- A notice of performance from QMB after a follow-up measures have

been taken.This enables management to influence internal improvement measures andtrack the performance of the measures and their effectiveness.

Auditor

3.7 Evaluation of audit findings

Audit findings are generally evaluated. Definitions of the evaluation can be found in Appendix 4. If necessary, the definitions should be adapted to suit the audit performed. The

evaluation definitions should accompany the audit report so that the facility audited canassess the seriousness and urgency of rectifying findings.

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4. ReferencesGerman Drug Law (AMG) of 12 December 2005 (BGBl. I p. 3394)

Medical Devices Law (MPG) of 7 August 2002 (BGBl. I p. 3146)

ICH Topic E6, Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95), 1997

Regulation on the Application of Good Clinical Practice when Conducting Clinical Trials withMedicinal Products for Human Use (GCP Regulation – GCP-V). Berlin: Federal Ministry for Health and Social Security. 9 August 2004. (BGBl. I 2004 S. 2081)

DIN EN ISO 9000:2000

DIN EN ISO 9001:2000

DIN EN ISO 19011:2002

"Guidelines for quality auditors planning and performing audits according to DIN EN ISO9001:2000", Hanser-Verlag

5. Changes from last versionNone – first version

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QS01-H Internal Audits V01 en Outdated

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