EMA updated their Q&A on GCP webpage

How should data be presented when they are sent to the inspection team prior to a GCP inspection requested by the CHMP?

In connection with centralized applications, the Committee for Medicinal Products for Human Use (CHMP) often requests a good clinical practice (GCP) inspection of one or more sites to be performed. Prior to such GCP inspections, the European Medicines Agency (EMA) sends an announcement letter to the applicant in which – among others – a list of documents to be provided to the inspection team is presented. The data are used by inspectors for review in order to select patients and data to inspect. Among the requested documents are the individual patient data listings for the patients recruited at the sites to be inspected. Based on past experience, this request for data listings poses a significant number of problems and subsequently costs a lot of time for companies and inspectors, quite often resulting in listings of suboptimal quality.

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