The following steps are typically followed as part of the audit process by the NJRO Quality Assurance (QA) Management team:

1. An audit invitation is sent to the auditees.  All staff required to attend the audit are identified and they must make themselves available for the audit.
2. An audit date, duration, location and attendees will be agreed, including room bookings.
3. Auditees provide the auditors with pre-audit documentation for review prior to the audit within specified time frames.
4. A full audit agenda is provided to auditees in advance.
5. On the day of the audit, the following structure is followed:
   • Opening meeting – audit arrangements discussed, including audit structure, timeframe, requirements of staff and plans for the exit meeting.
   • Audit commences in line with agenda.
   • Exit meeting – Overview of audit findings presented and discussed.  Auditees offered the opportunity to provide additional information against findings.  If key staff cannot attend, a follow up email will be sent summarising the key points.
6. Report – Auditors provide a written report within an agreed timeframe, including a list of Corrective and Preventative Actions (CAPAs) and recommendations to address any findings.
7. Report review – Auditees review the report within a given timeframe, confirming agreed CAPAs, responsibilities and timeframes for completion.
8. Report approval – Auditors review the action plan provided by the auditees for suitability to address the findings. Further conversations may be required if actions are deemed inappropriate/insufficient. 
9. Audit closure – Once the auditors are satisfied that actions suitably address the findings, an audit certificate will be issued and the audit closed.

In addition to regular audits by the NJRO QA Management team, staff are also required to conduct regular self-assessment audits.  These may be conducted at any time, but the minimum frequency must be agreed with the NJRO QA Management team.  The procedure is different for Research Studies and Research Tissue Banks.  A summary of the procedures for each is provided below.

Research Studies:

1. Audit – Staff complete self-assessment audits using the self-assessment tool, and return these to the NJRO QA Management team for review.
2. Review – The NJRO QA Management team review the self-assessment, seeking clarity where required. 
3. Report – The NJRO QA Management team write a formal report and provide this to the auditee, confirming required Corrective and Preventative Actions.
4. Actions – Staff review the report and action plan, confirming actions to be completed, timeframes and responsibilities.   Report to be provided back to the QA team within an agreed timeframe.
5. Report approval – QA review the action plan provided by the auditees for suitability to address the findings. Further conversations may be required.
6. Audit closure – Once the auditors are satisfied that the actions suitably address the findings, an audit certificate will be issued and the audit closed.

Research Tissue Banks:

1. Audit – Staff complete self-assessment audits, using appropriate templates identified in NJRO-TISS-SOP-004. 
2. Report – Staff write a formal report and provide this to the NJRO QA Management Team, confirming required Corrective and Preventative Actions to be undertaken, timeframes and responsibilities.
3. Acknowledgement – QA review the audit and provide any feedback on the suitability of the findings to address the findings, or suitability of audit procedures.
4. Audit closure – Once QA are satisfied that actions suitably address the findings, confirmation will be sent by email.  Progress against audit actions will be assessed during NJRO QA Management audits.

In the NJRO we track findings generated in a given period to determine trends and patterns. We can then use this information to ensure shared learning across teams, and promote process improvements.  Some examples of common findings to look out for under GCP or human tissue regulations are provided below:

Major Findings

• Informed Consent Forms (ICFs) are
  • not complete
    • Signatures of participant or researcher are missing
    • Pages are missing or have not been annotated
  • have been completed on behalf of the participant (without appropriate explanation)
  • reference incorrect versions of the Participant Information Leaflet (PIL) (e.g. version number and/or date)
• Incorrect PIL provided
• Eligibility confirmation is incomplete/ inconsistently documented
• Sample traceability – samples could not be retrieved during the audit.
• Documentation
  • Protocol has not been signed by the PI to confirm agreement to conduct activities according to the protocol
  • Lack of appropriate documented policies/procedures (e.g. SOPs)
  • Lack of evidence of reading procedures.
• Training –
  • No evidence of GCP, Informed Consent or HTA training (as applicable)
  • Missing CV
• Delegation: tasks not appropriately delegated by the PI, or delegation log not reflective of staff conducting trial related tasks

Other/ Minor Findings

• Informed Consent Forms
  • Do not have participant identification numbers on them
  • Have non-GCP compliant corrections
• Documentation for some patients are blank but without explanation i.e. study checklists
• Incorrect version references in documents
• Documents are not version controlled through version number and date
• CV not signed or dated
• Annual reports not submitted in correct format.