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Version 1. 21.07.2011. Auditing SOP SOP Title Template SOP SOP No. SOP 12 Author Julia Farmery Consulted Departments Lincolnshire Clinical Research Facility, Research and Development, Trust Consultants and research staff. Lead Manager Sign and Print Name Dr. Tanweer Ahmed Director of LCRF and Research and Development Manager Date published 21.07.2011 Review date of SOP 21.07.2013 Version 1

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Page 1: Auditing SOP - United Lincolnshire Hospitals · Version 1. 21.07.2011. Auditing SOP SOP Title Template SOP SOP No. SOP 12 Author Julia Farmery Consulted Departments Lincolnshire Clinical

Version 1. 21.07.2011.

Auditing SOP

SOP Title Template SOP

SOP No. SOP 12

Author Julia Farmery

Consulted Departments Lincolnshire Clinical Research Facility, Research and

Development, Trust Consultants and research staff.

Lead Manager Sign and Print Name

Dr. Tanweer Ahmed Director of LCRF and

Research and Development Manager

Date published 21.07.2011

Review date of SOP 21.07.2013

Version 1

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1. Purpose:

This SOP describes the audit procedure of United Lincolnshire Hospitals Trust. This SOP specifically describes the processes for selecting those studies for audit that fall under the Department of Health Research Governance Framework for Health and Social Care 2005 (2nd Edition) and/or the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments; the procedures for carrying out audits; and reporting audit results to Investigators. This SOP also describes the requirements for Investigators to respond to ULHT audit reports and implement corrective actions.

As a host organisation under section 3.10 of the Research Governance Framework ULHT has a responsibility for auditing research practice and assuring adherence to current legislation and guidelines. As such, it is necessary to audit research for which ULHT is participating in; against the standards of the Research Governance Framework 2005 (2nd Edition), and the Medicines for Human Use (Clinical Trials) Regulations 2004 where applicable, and against the quality systems of Good Clinical Practice intrinsic to the Regulations.

This guidance is to assist researchers in understanding the audit process, so that they are prepared should they volunteer or be selected for internal audit.

The purpose of a research audit is to:

Ensure participant and staff safety.

Assist researchers with compliance to regulatory requirements.

Improve research systems and data quality.

Prepare researchers for external processes of regulatory inspection.

Demonstrate robust research processes to external funders and industry.

1.1 Audit requirement

Under the Research Governance Framework, the Sponsor is responsible for the management and monitoring of a study. ULHT is responsible for auditing 10% of research projects on a yearly basis, as detailed in the Research Governance Framework for Health and Social Care 2005 (2nd Edition).

Projects will be audited:

On a voluntary basis.

As a result of a risk graded assessment.

If there is suspicion of non-compliance to regulation.

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The yearly R&D reports, do not constitute audit and should be submitted for every study in addition to audit requirements.

1.2 Role of the Auditor

It is the auditor’s primary role to collect evidence of research practice and compare it against the requirements of Good Clinical Practice and Research Governance. The Auditor is responsible for documenting observations and conclusions, safeguarding audit documents, records and reports, assessing whether requirements are being met, and developing reports incorporating recommendations for change or adherence.

2. Applies to: All individuals working with, alongside or participating in research activity.

3. Relevant SOP documentation : Relevant to all hosted and sponsored studies conducted at ULHT

4. Definitions : R&D – Research and Development

5. Policy: The UK Clinical Trial Regulations No. 1031, No. 2754, No. 2759, No. 1928, No. 2984, No. 941, No. 1164. Department of Health Research Governance Framework for Health and Social Care (2005) 2nd Edt. ICH, GCP Guideline, 1996.

6. Procedure: Auditor Qualifications The Auditor should be independent to the research team to conduct audits appropriately. An auditor should be qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented (ICH GCP 5.19.2).

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Audit Plan An audit plan will be developed by the Research Governance Manager and agreed with the researcher involved prior to beginning the audit. The plan should:

Define the scope and objectives for audit.

Provide timelines for audit conduct.

Identify where and when the audit will take place.

Identify requirements to be audited against.

Identify groups and areas to be audited.

List documents and records to be studied.

List responsible people whose functions will be audited.

Clarify who will get the final report and when it will be ready. Physical Audit Process This is the most intensive part of any audit process as it is the period where information is assessed and recorded. The process will start by the Research Governance Manager, explaining the scope and objectives of the audit, and how it will be carried out. Examples of audit techniques include:

Interviewing researchers

Reading documents

Reviewing manuals

Studying Records

Reading reports

Analysing data

Observing activity

Examining conditions

Confirming interview evidence

Documenting observations Audit Findings Once the practical audit has been completed the Research Governance Manager will develop a summary and make preliminary recommendations to assist with research conduct. The Research Governance Manager will:

List any gaps in compliance with any supporting evidence.

Cross-reference with regulatory requirements. Grading of findings Monitoring visit findings are graded using the following criteria: Major: A finding defined as one with the capacity to directly undermine the integrity of the entire study. For example findings:

Where evidence exists that the safety, wellbeing, rights or confidentiality of study subjects has been (or has had significant potential to be) jeopardised.

Where reason has been found to cast serious doubt upon the accuracy and/or credibility of study data.

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Where approval for the study has not been sought from one or more regulatory agency/body or granted from one or more regulatory agency/body (e.g. Ethics committee, MHRA) but the study has commenced regardless.

Where procedures not covered/included on the consent form are being performed or where new procedures have been introduced into the study protocol but where participants who had consented prior to their introduction have not been asked to re-consent.

Where following study approval, significant amendments have been made to the study protocol or documentation but no new request for approval has been submitted.

Moderate: A finding defined as one that compromises the integrity of a certain component(s) of the study, for example:

Where there has been failure to comply with the regulatory requirements e.g. failure to assess and report SAEs and/or SUSARs accurately and to the correct bodies.

Where there has been a significant unjustified departure from GCP e.g. failure to provide participants with a copy of their Consent Form or Participant Information Sheet.

Minor: Any other inspection findings, defined as those where the integrity of the study is not directly compromised but which represent an absence of due diligence on behalf of study staff towards the conduct of the study. For example findings:

Which demonstrate that no definite document management/organisation processes are in place at site / no investigator site file exists.

Where there has been failure by study staff to inform the relevant authorities of amendments to start and stop dates or study specific documents.

7. Responsibilities Audit Results Where there are many areas of improvement to develop, the Research Governance Manager will arrange a meeting with relevant research staff to discuss the recommendations or gaps in compliance. This can be used to develop solutions to any problems identified through the audit. Final Audit Report Over the following two – four weeks from initial audit, the Research Governance Manager will review the gathered information and compile a final report. Which will be disseminated to the Principal Investigator and other relevant personnel specific to the audit. Finally the results and conclusions will be presented to the R&D committee, before being stored in the R&D department. The report will include:

The detailed audit plan.

A review of the evidence collected.

A discussion of any conclusions drawn from the audit.

A list of identified gaps in compliance.

An assessment of how well regulatory requirements have been met.

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Recommendations for change in practice to conform to regulation.

A date for recommended review. Follow-up actions It is the Principal Investigator’s responsibility to ensure action is taken to correct any identified gaps in regulation compliance. If any advice or assistance is required the Research Governance Manager will be able to help with this. The Principal Investigator of the study is expected to respond to the audit report within 2 months and corrective actions made within a timely manner.

References: Department of Health Research Governance Framework for Health and Social Care 2005 (2nd Edition). UK Clinical Trials (Medicines for Human Use) Regulations 2004; ICH, GCP Guidelines 1996. Please note, a large majority of this information and guidance has been taken from the Joint Research Office Audit SOP, Version 3. From Imperial College Healthcare and Imperial College London. Many thanks are given, with acknowledgement and permission granted by author Lucy Parker, Research Governance Manager.

This SOP will be reviewed every two years, a more updated revision of the SOP will be implemented if new local, national or international regulations

change. This would therefore replace the existing document. All SOPs can be located on the Research and Development’s shared file and a hard copy of all

SOPs are kept in the SOP Trial Master File.

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ULHT Audit Plan for Research Studies

Objectives The objective of this audit is to ensure compliance with <if IMP study> Medicines for Human Use (Clinical Trials) Directive 2004, incorporating amendments (2006) from the EU Directive 2005/28/EC on GCP <if non-IMP study> Research Governance Framework for Health and Social Care, 2

nd

Edition, 2005. For all the studies, we will be looking for adherence to Good Clinical Practice as outlined in the ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996). The final audit

report will document findings against these guidelines. Project to be audited

Project Title ULHT ref PI Type of study Clinical Trial IMP

Audit site Date of audit Essential documents to be available during the audit Protocol

Consent form and Patient Information Sheets

Ethics approvals and correspondence

Research and Development approval and correspondence

Ethics correspondence

Regulatory approvals and correspondence (e.g. MHRA, GTAC etc) (IMP study only)

General study correspondence (except Trust, Ethics and Regulatory. Training documents

SOPs

Data management

Serious Adverse Events

Pharmacy/Product-Related (IMP study only)

Monitoring and Audit documentation Source data (i.e. patient notes)

Audit Timeline On the day, the auditor(s) will introduce themselves and explain the planned procedure for the day. It would be useful if a separate room could be organised for the auditors to review the documents. For the studies that have started recruiting participants, a selection of patient notes should be made available for source data verification. Once the audit is complete, the auditor(s) will briefly go through the findings with the study personnel, and PI if present. A formal report will be provided within two weeks of the audit, addressed to the Principal Investigator, with copies sent to the co-investigators, research nurses and R&D personnel. A response form the PI to the audit findings should be provided within 2 months of receipt of the audit report.

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Principal Investigator

Nurse/Officer

CRFs selected Time to meet research staff and Principal Investigator.

Close out meeting

Protocol

……………………………………..□ Version □□

……………………………………..□ Version □□

Current Documents

Name of Study

Venue

Date

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Audit Plan

Study Title :

Summary of study

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Section 1: Approvals

Yes No Comments 1 Ethics Approval a Is there a record of full approval from REC? Date: Ref:

b If provisional approval, response fully documented? c If amendments have been made, were these notified to the REC d Have SSIs been received for each active local site? 2 Sponsor and Indemnity a Does the project have sponsorship? Date:

3 R&D Approval a Does the project have R&D approval? Date:

4 MHRA Approval a Are appropriate CTA approvals in place? Date: CTA ref:

b EudraCT number received EudraCT:

5 PIAG, UKXIRA, and other regulatory approvals not mentioned above

a If applicable, does the study have appropriate approval? 6 GTAC a Does the study have GTAC approval? b Have SSIs been received for each active local site?

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Section 2: Protocol and PIS

Yes No Comments

7 Protocol a Is the final version of the protocol in the ISF? b Are all amendments clearly indicated, superseded. c Is protocol being followed accurately? 8 PIS, consent and GP letters a Is the PIS on headed paper with a version number?

b Is the consent form on headed paper with a version number?

c Do the PIS and consent version numbers and dates match?

d Are all essential documents approved by R&D and Ethics?

e Is there a full record of all research participants written informed consent?

f Have participants and researcher completed consent correctly

g Is the consent form signed by participant and researcher on same dates?

h Is a copy of the PIS and consent kept in the patient notes?

i Are consented participants eligible?

j Does the consent form include permission to inform GP?

k Has the GP been informed of participant’s taking part in study?

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Section 3: Study Conduct

Yes No Comments

9 Data Protection a If study involves transfer of data to 3

rd party, is there specific

consent? Is DPA adhered too?

b Are the paper records stored in a locked filling cabinet?

c Are electronic files stored on a password protected computer?

d If patient details are stored on computers are they anonymised or ULHT key coded?

e Is the PIS on headed paper with a version number?

10 Procedures a Have individual study procedures been written? (eg: SAEs, tissue,

consent, rand/reg, data management, SOPs). Are they current & up to date?

11 Annual Reports a Have annual progress reports been sent to REC, Sponsor and

MHRA?

b Is a copy, signed and dated & held in ISF?

12 Training a Do members of the research team have individual training folder?

b Can they demonstrate knowledge of GCP?

c Is there a current study delegation log?

d Are all study team members informed of study and procedures?

13 IMP studies a Is a drug accountability form being completed (i.e. receipts,

dispense, returns are controlled and documented)?

b Storage, labelling and disposal of IMP per pharma instructions?

c Study listed on a public database prior to entry of first patient?

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Yes No Comments

14 Safety Reporting a Is there a record of all AEs, SAEs, SUSARs arising during the

research? □ □

b Have annual safety reports been sent to REC, Sponsor and MHRA? (if applicable)

□ □

c Have SUSARs undergone expedited reporting and Trust IR1 reporting for ULHT events?

□ □

d In protocol, is there a list of expected events? □ □

e Evidence of continued review of safety of IMP? □ □

15 Tissue studies a Is the tissue from a recognised tissue bank or has project-specific

Ethics approval? □ □

b If tissue is being stored post Ethics-approved project, is this being consented to?

□ □

c If tissue is being stored post-Ethics approved project, is this covered under an appropriate licence from HTA?

□ □

d If genetic analysis is taking place, is there appropriate consent? □ □

16 Steering Committee/Data Monitoring a Does the study have a TSC or DMC? If yes, proof of meetings

(minutes) or documents. □ □

17 Source Data Verification* a Does the data recorded in the CRFs match that recorded in the

Source Documents? □ □

b If there are discrepancies between the CRFs and the source data, have these been explained and signed for?

□ □

Yes No Comments 1 Protocol

a Is the final version of the protocol in the ISF? □ □

b Are all amendments clearly indicated, superseded and notified to REC?

□ □

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1 Ethics Approval

a Is there a record of full approval from a REC? □ □

b If the REC specified any amendments/restrictions/conditions to the protocol, have these been made/adhered to/

□ □

c If amendments have been made, were these notified to the REC/Sponsor/MHRA where applicable?

□ □

2 PIS, consent and GP letters

a Is there a full record of research participants’ written informed consent?

□ □

b Is the PIS on headed paper with a version number? □ □

c Is the consent form on headed paper with a version number? □ □

d Do the PIS and consent version numbers and dates match? □ □

e Is the consent form signed by participant and researcher on the same date?

□ □

f Has a copy of PIS been given to participant? □ □

g Are the consent forms kept in a secure location? □ □

h Is a copy of the PIS and consent kept in the patient notes? □ □

Yes No Comments i Does the consent form include permission to inform GP? □ □

j Has the GP been informed of participant’s taking part in the study? □ □

3 R&D Approval

a Does the project have R&D approval? □ □

b If the trust approval was subject to modifications being made to the research design and protocol, were these amendments made prior to the project starting?

□ □

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4 Data Protection

a Does the project meet the Data Protection Act? □ □

b If study involves transfer of data to 3rd

party, is there specific consent?

□ □

c Are the paper records stored in a locked filing cabinet? □ □

d Are electronic files stored on a password protected computer? □ □

e If patient details are stored on ULHT computers, are they anonymised?

□ □

f If patient records are accessed without consent, is there approval from PIAG?

□ □

5 Annual Reports

a Have annual progress reports been sent to REC and MHRA (with copy to ULHT)

□ □

6 Adverse Events

a Is there a record of all AEs, SAEs and SUSARs arising during the research?

□ □

b Have annual safety reports been sent to REC, Sponsor and MHRA? (if applicable)

□ □

c Have SUSARs undergone expedited reporting? □ □

7 Procedures

a Have individual study procedures been written? (e.g. SAEs, tissue, consent, rand/reg, data management)

□ □

b Is there a current study delegation log? □ □

8 Training

a Do members of the research team have individual training folders? □ □

b If not, can they demonstrate knowledge of GCP? □ □

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9 IMP studies

a Has full CTA approval been received from each component Authority in each participating country?

□ □

b EudraCT number received □ □

Yes No Comments c Study listed on a public database prior to entry of first patient? □ □

d Is a drug accountability form being completed? □ □

10 Tissue studies

a Is the tissue from a nationally recognised tissue bank or has specific Ethics approval?

□ □

b Is the tissue being used for more than 1 project? □ □

c If tissue is being stored post ethics-approved, is this being consented to?

□ □

d If genetic analysis is taking place, is there appropriate consent? □ □

e Is the stored tissue anonymised or pseudoanonymised? □ □

f Is a procedure in place for tracing samples back to the donor? □ □

11 PIAG, UKXIRA and other regulatory approvals not mentioned above

a If applicable, does the study have appropriate approval? □ □

12 GTAC

a Does the study have GTAC approval? □ □

b Flagging project for integrating viral vector studies? □ □

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The above details recorded on ( ) are correct and accurate to the best of my knowledge. Signature of Auditor…………………………………………………………………

Print Name:……………………………………………………………………

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Audit Report Contents Part A: Visit Details…………………………………………………………………………………17 Part B: Introduction…………………………………………………………………………………18 Part C: Responses…………………………………………………………………………………18 Part D: Findings ……………………………………………………………………………………19 Grading of findings………………………………………………………………………..18 Part E: Comments and Observations……………………………………………………………18 Visit findings……………………………………………………………………………….19 Part F: Summary………………………………………………………………………………… 19

Part A: Visit Details Project title: R&D ref: PI: Type of study: Site audited: Date of audit:

Personnel Present: Julia Farmery Contact details: Lincolnshire Clinical Research Facility, Lincoln County Hospital, Greetwell Road, Lincoln, LN2 5QY Tel: 01522 512512 ext 2915 Fax::01522 543783 Email: [email protected] Site Staff: Contact details:

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Part B: Introduction

The purpose of this report is to document the results of the R&D ULHT audit of the above study and detail any findings identified by R&D ULHT staff during the course of this visit. Study findings are divided into three grades according to their seriousness: Major, Moderate and Minor; a definition of each can be found in section D. You are required to provide the R&D ULHT with a response within 2 months of receipt of this report. This response should detail the actions that have been taken to remedy each of the findings. In the case of Major findings the R&D ULHT may require that the PI provide evidence that the recommendations have been taken and may additionally conduct further monitoring visits to re-assess the site. Findings listed in this report may include references to ICH-GCP (International Conference on

Harmonisation Good Clinical Practice) guideline, the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI:1031) ) incorporating amendments on GCP (SI:1928), Data Protection Act

1998, the Research Governance Framework for Health and Social Care, 2nd

Edition (2005). Please note that this list is not exhaustive

Part C: Responses

Responses should be made in writing to the R&D ULHT at the address above and should be sent within 2 months of receipt of this report. Each finding detailed in this report is numbered; the response should list each finding identified and detail the actions that have been/will be taken to address them. The response should be dated and should be signed by the Principal Investigator (PI) for this study. Should the PI or any member of site staff feel that the findings of the visit documented in this report do not accurately represent the conduct of the study, they may request further consultation with the R&D ULHT. This request should be made in writing to the R&D ULHT within 2 weeks of receipt of this report. The request will need to be signed by the PI, should state the reason for request and be directed to those R&D ULHT staff who conducted the original visit. Upon receipt of the request for consultation the primary action of the R&D ULHT will be to confrirm receipt and to schedule a meeting between the PI/site staff and those members of the R&D ULHT who conducted the initial visit. The purpose of this meeting will be to discuss the findings of the visit and ascertain where the differences of opinion lie with the aim of ultimately resolving these differences.

Part D: Findings

Grading of findings Monitoring visit findings are graded using the following criteria:

Major: a finding defined as one with the capacity to directly undermine the integrity of the entire

study. For example: ▪ Where evidence exists that the safety, wellbeing, rights or confidentiality of the study subjects has been (or has had significant potential to be) jeopardised. ▪ Where reason has been found to cast serious doubt upon the accuracy and or the credibility of the study data. ▪ Where approval for the study has not been sought from one or more regulatory agency/body (e.g. Ethics Committee, MHRA) but the study has commenced regardless ▪ Where procedures not covered /included on the consent form are being performed or where new procedures have been introduced into the study protocol but where participants who had consented prior to their introduction have not been asked to re-consent ▪ Where following study approval, significant amendments have been made to the study protocol or documentation but no new request has been submitted.

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Moderate: A finding defined as one that compromises the integrity of a certain component(s) of the

study, for example: ▪ Where there has been failure to comply with the regulatory requirements e.g. failure to assess and report SAEs and/or SUSARs accurately and to the correct bodies. ▪ Where there has been a significant unjustified departure from GCP e.g. failure to provide participants with a copy of their consent form or Participant Information Sheet.

Minor: Any other inspection findings, defined as those where the integrity of the study is not directly

compromised but which represent an absence of due diligence on behalf of study staff towards the conduct of the study. For example findings: ▪ Which demonstrate that no definite document management/organisation processes are in place at. site / no investigator site file exists ▪ Where there has been failure by study staff to inform the relevant authorities of amendments to start

Part E: Comments and Observations

Visit findings During auditing, staff from the R&D ULHT identified findings; of these have been graded as Major, have been grade as Moderate and have been graded as Minor findings. 1. Grade: Major Relevant Guidelines(s): Description: Recommended actions: 2. Grade: Minor Relevant Guidelines(s): Description: Recommended actions:

Part F: Summary

We will need you to reply to this report within 2 months of receipt and inform us of what actions have been taken to address the findings listed above. If you have any queries please do not hesitate to contact Julia Farmery. The above details recorded on are correct and accurate to the best of my knowledge. Signature of Auditor(s)………………………………………………………………. Print Name........................................................................................................

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