Clinical Research and GCP Update

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EMA IWG Q&A Q9 Amended- Sponsor submit an MAA without documentation of qualification of computerised data collection tools/software. April 2020

• The sponsor should make sure that such documentation is readily available for inspection if requested. Failure to provide access to the documentation is likely to result in critical findings that will impact the acceptability of the clinical trial data. • A sponsor should amend any contract with vendors to ensure availability of qualification documentation . • In case a sponsor cannot rely on a vendor to provide documentation, the sponsor has to requalify the system

• Sponsor Inspection Findings -- lack of documentation and inadequate vendor assessment prior to trial initiation .

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UK Medicines and Medical Devices Act 2021

• Clinical Trials Regulations section 2(1) — • Corresponding or similar to provision in the EU Clinical Trials Regulation, about authorisations concerning clinical trials in the UK, including applications for an assessment of the ethics of a proposed clinical trial, …. relating to the conduct of clinical trials. • “EU Clinical Trials Regulation” means Regulation (EU) No536/2014 of the European Parliament and of the Council of 16 April 2014. • Bill received Royal Assent on 11 February 2021, now an Act of Parliament (law).

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