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Verifying the reliability, safety and ethics of IT systems for clinical research

TMF training workshop on system validation

8 December 2016. Over 20 participants from 16 research institutions converged at TMF on 8 December for a training workshop. Their goal: to obtain and exchange information on best practices and requirements for validating IT systems for clinical studies – specifically in GCP (good clinical practice) environments. The workshop was based on recently updated TMF documents on system validation.

Software support for clinical trials is a key component of the IT infrastructure in clinical research centres. To conduct studies that meet GCP standards – including in university environments – scientists must demonstrate that their software solutions comply with legal requirements. The aim is to validate the high quality of data and processes, and patient safety – the vital basis for ensuring the ethical nature of clinical studies. The workshop was conducted within the scope of a TMF project dedicated to updating its existing, comprehensive set of documents on system validation.  

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