The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no longer apply to the United Kingdom (UK) upon the official withdrawal date.
Brexit Impact on EudraCT Postings
The notice states that protocol-related information from clinical trials conducted in the UK will no longer have to be submitted to EudraCT except when the trial is part of an agreed Paediatric Investigation Plan and the UK is the only country in which the protocol has been submitted.
Results of completed clinical trials conducted in the UK before the withdrawal date must still be submitted to EudraCT if the reporting of these results is due. Results of clinical trials conducted only in the UK and results of multi-country trials where the UK was the only EU/EEA Member state where the clinical trial was conducted still have to be submitted to EudraCT if this is required for non-EU/EEA studies (i.e. if the trial is part of an agreed Paediatric Investigation Plan or falls in the scope of Article 46 of Regulation (EC) No 1901/2006).
治験情報の掲載と試験結果の開示
Companies should still consider that documents uploaded for any results posting are in the public domain and should be carefully reviewed for any protected personal data (PPD) and/or company confidential information (CCI) and redacted accordingly.
The Synchrogenix ClinGenuity Redaction Management Service (CRMS) is the only artificial intelligence (AI)-enabled redaction technology solution in the marketplace. Combining expertise and AI technology, Synchrogenix generates CSR Synopses, protocols, SAPs, and ICFs that are consistently redacted for PPD and CCI. Our redaction process supports European Medicines Agency (EMA), Food and Drug Administration (FDA), and upcoming Health Canada requirements. This allows these redacted reports to be repurposed for other agency deliverables such as EMA Policy 0070, thus reducing re-work. Additionally, Synchrogenix ensures that the documents are in the required format and contain the applicable information for easy uploading to CT.gov or EudraCT.
