The guidance below aims to ensure your site is ready for an audit or inspection.
A systematic and independent examination of trial related activities. and documents to determine whether the trial related activities were conducted, recorded and reported according to the protocol, the sponsor's SOPs, GCP and the applicable regulatory requirements.
Any appropriate entity can conduct an audit or inspection, this includes sponsors, Clinical Research Organisations (CROs) and regulatory authorities.
Sponsor and CRO audits usually check that study activities have been conducted according to the protocol, and that data has been collected and managed according to the protocol, relevant SOPs, ALCOA principles and GCP.
Audits by regulatory authorities usually focus on checking that site processes are in accordance with GCP, SOPs and local clinical research laws and regulations, as well as ensuring patient/participant safety.
The process for identifying patients
Informed consent taking and documentation process
Regulatory approvals and correspondence with regulatory authorities
IMP management
AEs and SAEs
Adherance to the protocol
Source documents and their completion
Delegation logs and training logs
Randomisation process
Samples collection processes, including lab processing, storage and shipment
PI oversight
Facilities
Archiving
Compliance with the protocol, laws and regulations
Equipment calibration
Availability of appropriate emergency equipment on site
Investigator Site File completeness
Sometimes audits are conducted as part of a standard procedure, but these can also be triggered by certain scenarios.
Examples of scenarios that may trigger an audit/inspection include:
A high number or serious data discrepancies.
Repeated compliance issues.
Critical protocol deviations.
Suspected misconduct.
High recruitment.
A high number of active studies.
These triggers don't necessarily indicate that there is an issue at the site.
The inspector/auditor will contact you to let you know that they plan to schedule an inspection/audit.
Occasionally these can occur with short or no notice. It is therefore important maintain a position of 'inspection readiness', meaning that you keep all site and study documents up to date on a regular basis and all staff training is up to date.
If the inspector/auditor is not from the sponsor, you should inform the sponsor that an inspection is planned for your site.
Use the time before the inspection to review that all study documentation is up to date and available. Your site monitor will be able to support you if any documents are missing.
Reserve a room that the inspector can use.
During the visit, the inspector/auditor will likely hold an opening meeting at the beginning of the inspection and a closing meeting at the end.
You should ensure that all study documents and site documents that relate to delivery of the study are available for review.
The inspector may also request a tour of your facility and to hold interviews with specific staff members.
After the inspection you will be provded with a written report of the findings. You will be expected to provide a written response to the report, detailing how any findings are being addressed.
Be honest and be prepared.
You only need to provide the information that has been requested.
You can ask for clarification or ask for time to find out the answer to any questions.
Remain professional and avoid becoming defensive when asked questions.
Audits/inspections can help you learn and improve site processes.