Clinical Study Audits
Overview
The conduct of clinical studies to ensure compliance with the relevant regulations provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical studies are credible and accurate. With the ever changing regulatory requirements and increasing demand for clinical studies to generate high quality data, the need for audit is evident. Regulatory inspections are routinely carried out for medicinal products and in some European countries, clinical studies with medical devices are also inspected.
Medvance has a strong expertise for conducting all types of clinical Audits in the medical device arena and has a well established and experienced team of auditors.
What type of Audits?
Medvance can provide Audit services as follows:
• Investigator Site Audits – Audit of study sites to determine the study has been carried out in accordance with the protocol and applicable regulations
• Study Master File Audits – comprehensive review of all essential documentation to ensure compliance with the Sponsor SOP and applicable regulations
• CRO Audits – evaluation of CRO to check compliance with the SOPs and applicable regulations for on-going or completed projects or prior to CRO selection
• Database Audits – Audit of a sample of study data against CRFs to ensure data accurately recorded
• Clinical Study Report Audit – Audit of clinical study report against the clinical data to ensure the results have been accurately reported
• Research Ethics Committee Audits
• Standard Operating Procedures Audits – Audit of clinical SOPs to ensure compliance with the applicable regulations
• Systems Audits – Audit of identified system to check compliance with the process
What regulations do we Audit to?
Audits will be conducted according to the relevant regulations depending on the protocol requirements and applicable regulations for the type of device and may include:
• EN ISO 14155-1:2003 and EN ISO 14155-2:2003. Clinical Investigation of Medical Devices for Human Subjects.
• ISO 13612 Performance of In vitro Diagnostic Medical Devices
• Active Implantable Medical Device Directive 90/385/EEC (AIMD).
• Medical Device Directive 93/42/EEC (MDD).
• In Vitro Diagnostic Medical Device Directive 98/79/EEC (IVMDD).
• Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95).
• Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
What does the Audit process involve?
Before each Audit an Audit plan will be prepared and the auditor will liaise with the audit site to make the necessary arrangements. The Sponsor will be verbally contacted following each Audit to provide a brief overview of the findings and a final Audit report will be issued detailing the findings from each Audit and the impact of these findings. An Audit certificate will also be issued for each Audit.
Key Benefits for using Medvance
• Substantial experience of clinical Audits in the medical device arena including in vitro diagnostic devices
• Tailored made Audit plans to maximise Audit process
• Flexible pricing plan to meet specific requirements
• Highly trained staff with industry experience
• BSI professionally trained auditors
Next Steps
Please contact us for more information or a proposal for carrying out a clinical Audit.
