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EMA position on on-site and remote audits

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  • Fiona Booth
    25/08/2020 13:31
    I'd be interested to her how members are reviewing and revising their quality plans as we progress through these uncharted waters, specifically looking at the issue of site audit conduct. The EMA's published position (per V3 of the guidance dated 28/04/2020) on audits is as follows: 12. In the current situation, on-site audits should, in general, be avoided or postponed. Audits should only be conducted if permitted under national, local and/or organisational social distancing restrictions. For critical trials, on-site audits as well as remote audits can be considered, after agreement with the investigator and if the audits are assessed as essential, e.g. triggered audits with the purpose of investigating serious deviations from the trial protocol or from the applicable legislation. There is no definition in the guidance of what a "critical trial" , but the description in Annex 1 of trials where remote SDV is considered permission could be applied. My impression is that the majority of trials would not be considered a critical trial and so audit is not possible. Most trial programmes have a window for performing audit, after which point the trials have progressed to such a degree that the opportunity to use the audit process to address quality issues has passed. So for those trials do we revise our quality plans to state that it audit was not permitted under the EMA guidance? I'd be interested to hear other members views.
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