The eLearning course highlights that the aims of the site and inspector are the same - to verify the safety of participants and the integrity of the data.

 The introduction of the 13 GCP Principles at the beginning of the course was important and a suggestion was made that there would be value in having a large poster made of  these to be put up at one’s site.

 From a site perspective it is important to take note that the there is a difference between an audit and an inspection. The two types of audits are regulatory and sponsor audit.

 Table reference: “How to conduct GCP Inspections/Audits at the clinical investigator site” www.theglobalhealthnetwork.org

 

Audit

Inspection

Conducted by

Sponsor/CRO

Regulatory agency

Focus on

Compliance and process review

Patient safety and data credibility

Checked against

Regulations and sponsor SOPs

Legislation and guidance. Sponsor SOPs usually irrelevant

Vested interests

Ensuring study success

Public safety. Study success "irrelevant"

o    

Experiences of recent local inspections/audits by members of the discussion session brought to the fore the need to take cognisance of the following when taking a long-term perspective on preparing your team to be ready for a GCP audit or inspection.

·      The focus is on ongoing training of staff and moving away from mere qualifications.

o      It is important that within a team someone takes control for continous training and regular team meetings. The latter allows you to discuss and to document relay of relevant information to the team (e.g. changes to the protocol). An option is to circulate a memo of clarification after team meetings to highlight pertinent information, and even ask staff to sign off on the memo.

·       Your documentation will be thoroughly checked.

o    Source documents must reflect the protocol - avoid duplication (e.g lab reports don’t need to be recorded in a separate  source) as you don’t want the inspector /auditor to feel uneasy about which is the original document.

o    Maintenance, calibration and certification of equipment is important. A way to keep control of this is to have a maintenance plan (a simple excel spreadsheet) which flags when equipment will need calibration.

·      Specific detailed description of the process of informed consent is needed in participant notes.

·      If you are not within a hospital setting and the trial requires rapid access to an emergency facility (e.g. Phase 1) then emergency test runs can be recorded in your training record – it may be possible to have an ambulance service report which details how long it took to travel from the site to the emergency facility. NB for late phase trials – confirm with your sponsor what emergency evacuation/transportation protocols they require to be in place.

·      Internal QC by the site team is advantageous, especially as remote monitoring by sponsors becomes more common.

·      Maintain a good relationship with your monitor.

·      The eLearning course can serve as guidance on how to conduct oneself during an audit.  For example when preparing  staff  for the audit one could have  a practice run. The extract taken from the course on how an interview should be conducted by an inspector could be used to prepare staff  for the interview.

 

Put the person being interviewed at ease

Explain the reason for being interviewed

Ask the interviewee to describe his/her role in the trial, to describe his/her tasks, to describe any problems encountered and if so how they were resolved

Ask the person to clarify/explain any serious issues identified during the inspection/audit

Use mostly general, open-ended questions such as who? when? where? how? and avoid closed (yes/no) questions

Thank the interviewee at the end of the interview process

Table Reference: “How to conduct GCP Inspections/Audits at the clinical investigator site” www.theglobalhealthnetwork.org

 During a audit if you do not know the answer, tell the inspector/auditor you will find out and get back to them. If asked about someone else’s work  then it is suitable to refer the auditor/inspector to speak to the respective person.

At the close out meeting make detailed notes and do not be afraid to argue if you disagree with a finding. The auditor needs to tell you when they will give you the audit report.

Respond to the written audit findings by preparing and submiting  your response in a report  format timeously.

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