The entry into force of the EMA guideline on computerized systems and electronic data in clinical trials (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf), reopens the debate on the adequacy of the IT infrastructures of Italian hospitals and the adherence of all electronic systems, including electronic medical records, to the minimum requirements cited in the document.
Are the actors involved in clinical research aware of the tools available to them?
We witness every day in the field that there is a large and fragmented management of source documents with mixed systems (paper and digital) and only, in very few cases, a completely electronic one.
Is it necessary to have legislation that regulates the type of medical records in our hospital contexts? Are healthcare facilities ready to take up the challenge to align with international standards?
In the meantime, AICRO (Association of Italian Contract Research Organization) is moving to map the current situation through a survey promoted by the WG CTC coordinated by Dr. Antoinette Van Dijk, which will provide a clear starting point for dialogue with all interlocutors to create awareness on the topic and guide the route to comply with the guidelines.
DataRiver, as a member of AICRO and as a supplier of validated EDC systems (CSV), shares the importance of the AICRO press release, so that all authors involved in clinical research understand the importance of using validated systems (Computer System Validation).