Advisor 462

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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are fully investigated and that an appropriate and timely CAPA plan is implemented to address the findings, with appropriate prioritisation of critical and/or major findings • inform the EMA lead inspector if timelines for agreed CAPA deliverables change • ensure the timely evaluation of any new safety data identified through inspection • ensure timely communication about safety concerns to the competent authorities, patients and healthcare professionals, in particular notifying changes to the benefit-risk balance of concerned medicinal product(s) according to the urgency required (including the implementation of variations to marketing authorisations for safety reasons) • respond to requests from competent authorities, including the provision of correct and complete information.

be provided. The responses should address non- compliance and be provided in the form of a CAPA plan. • CAPA plan review and approval by the inspectors, to determine whether it is adequate – this should usually occur within 30 working days following receipt of the responses; a shorter review deadline (10 working days) applies for responses to inspections requested by the Committee for Medicinal Products for Human Use. • routine interaction within and between Member States and the EMA. • actions to be taken following the identification of inspection findings that may impact the robustness of the benefit-risk profile of medicinal product(s). • re-inspection planning. Sponsor responsibilities The main responsibilities of the MAH during the post-inspection period are to • ensure that findings identified during an inspection

Source:

EMA addresses validation and qualification of computerised systems used in trials

The European Medicines Agency (EMA) has issued a short Notice to sponsors on the validation and qualification of computerised systems used in clinical trials.

Recent inspection findings have included issues with the integrity, reliability, robustness and acceptability of data submitted within marketing authorisation applications (MAAs). This has led the GCP Inspectors Working Group – in cooperation with the Committee for Medicinal Products for Human Use (CHMP) – to issue a Notice (dated 7 April 2020) that highlights the requirements for sponsors/vendors providing computerised systems or services that are used to manage clinical trial data. It notes that European regulations require the information generated in a clinical trial to be recorded, handled and stored adequately for the purpose of ensuring effective regulatory inspection.

The International Council for Harmonisation E6(R2) Guideline requires sponsors to operate computerised trial data handling or computerised data systems, and to • validate these systems • maintain an audit trail for the initial entry of data and any subsequent changes • maintain a security system to protect against unauthorised access • maintain a list of individuals authorised to create, access, modify or delete data. Data integrity, reliability and robustness will depend on the design and validation status of the computerised systems used. Failure to document and therefore to demonstrate the validated

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Issue 462, 2020 www.brookwood-global.com