AUDIT AND INSPECTION
OF CLINICAL RESEARCH TRIALS
STANDARD OPERATING PROCEDURE NO / SOP 05DATE RATIFIED / Sep 2014
NEXT REVIEW DATE / Sep 2016
POLICY STATEMENT/KEY OBJECTIVES:
The purpose of this SOP is to describe the requirements for an audit or inspection of a site(s) at the Host Organisation.
POLICY AUTHOR: Katie Glickman; Research Facilitator
BACKGROUND
Audit is an essential element of a quality system. In order to meet the requirements of the European Union Directive on Clinical Trials (2001/20/EC) and research Governance (Department of Health, 2005) the Host Organisation (Trust) is required to have systems in place to ensure high quality research. It is intended that such systems will detect and help to prevent research fraud and maintain a high standard of research. The philosophy of these audits is initially to educate Principal Investigators (PI’s) with the requirements of the audit and identify areas for improvement within the research process at the Host Organisation. However, research misconduct will lead to the PI having all trials under their care stopped until a full investigation can be made.
Section 1.6 of the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines define audit as a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted and the data were recorded, analysed and accurately reported according to the protocol, sponsor’s Standard Operating Procedures (SOPs), GCP and the applicable regulatory requirements.
PURPOSE
The purpose of this SOP is to describe the requirements for an audit or inspection of a site(s) by both the host organisation and external auditors.
PROCEDURE
WHEN?
The National Institute of Health Research (NIHR) National Portfolio studies recruitment aremonitored from the data uploaded to and received by the Clinical Research Network (CRN). Where the Clinical drug trial is registered with the Medicines and Healthcare Products Regulatory Agency (MHRA) they may be subject to external inspection.
The Research department will conduct audits in preparation for any potential external audits and to maintain a clear standard for data collection amongst all studies.
The Research department will audit new Clinical drug trial studies within three months of the study commencing recruitment and will revisit the study every six months thereafter unless issues arise or a request is made for further visits.
All research undertaken in the field of Dementia and some mental healthclinical trialswill be included and any personnel included on the site signature log or named on the protocol or Integrated Research Application System (IRAS) form may be contacted/interviewed as part of the audit process. However, “for cause” audits (where there is concern about conduct or record keeping) can be done at any time and notice will be provided to research teams so that the auditor will have access to all required documents. It is anticipated that research teams who work on a clinical trial will utilise the Trusts internal audit tool and conduct their own internal audits in preparation for host and external audits. See appendix one for an example of an audit tool.
WHO?
Any employee of the Host Organisation, nominated by the Research Department can actively be involved in a Research Audit. An auditor cannot be a member of the research team for the project being audited, however they can be consulted during the audit and provided with a copy of the audit report at completion of the visit.
Any employee from the MHRA or the Food and Drug Administration (FDA) regulatory authority can conduct an external audit with Trust services for any study which is conducted clinical trial research. The FDA may conduct both announced and unannounced inspections of clinical investigator sites and will be required to display a notice of inspection. The MHRA will request in advance of their visit that a GCP Inspection dossier be completed in order to assess how the organisation operates so that they may schedule their audit appropriately.
HOW?
During the Audit / inspection:
The following may be reviewed:
Essential Documentation (see ICH GCP section 8.2):
If the inspection involves a clinical trial coordinated by a pharmaceutical company, the monitor will assist in checking that all documentation below is in place prior to the visit.
Essential documentation that may be inspected includes, but is not limited to:
- Trial Site File
The Trial site file should be kept up to date at all times
- Case Report Forms (CRFs)
All CRFs, questionnaires, diaries, etc. should be available during the inspection.
- Patient Notes
All patients’ hospital notes should be available for source data documentation verification. This should include up-to-date annotations, GP letters, laboratory results, radiological results and any other documentation relating to the patients’ participation in the clinical trial. If there are legitimate reasons why a patient’s hospital notes cannot be available, this must be explained, if possible in advance of the inspection.
- Pharmacy and Drug Records
All essential pharmacy documentation should be available, such as drug accountability records, drug storage records, drug shipment records etc.
- Central Files
Files generic to more than one trial, kept centrally in a research team should be available. For example, curriculum vitae, documented evidence of staff training etc.
If any study data has been archived, details of the whereabouts of the data should be available for the inspector and written confirmation for the archiving site that the data will be maintained / stored according to Data Protection and GCP standards.
Processes
Processes may be inspected, such as the process for taking informed consent, SAE reporting, communication between individuals/departments specimen processing etc.
Equipment
Any equipment that is being used in the study may be inspected to check validation and calibration records are maintained, e.g. Freezers, ECG machines, computers (usually only when electronic data capture is used) etc.
Personnel
Qualifications/experience of the PI, co-investigators and other key personnel will be assessed by reviewing CVs, training records and possibly discussions with the inspectors.
After the Audit / inspection:
The Organisation will provide written feedback of the inspection findings. If a response is required, this should be done within the timelines specifiedin the report provided and evidence of actions taken recorded in the site file and stored with the audit report.
OTHER RELATED PROCEDURES, POLICIES, LEGISLATION OR GUIDANCE
Lancashire Care NHS Foundation Trust Audit Tool
All other LCFT SOPs
GLOSSARY
Lancashire Care Foundation Trust (LCFT)
International Conference of Harmonisation Good Clinical Practice (ICH GCP)
Comprehensive Local Research Network (CLRN)
Integrated Research Application System (IRAS)
Case Report Forms (CRFs)
Appendix one: Sample Trust audit tool for investigational products
Appendix two: Sample Trust audit tool for non investigational products
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