Clinical data
Found 3 free book(s)
European Medicines Agency Policy Publication Clinical Data ...
www.ema.europa.eu• Clinical data (either data provided to the Agency before 1 January 2015 or data not yet held by the Agency) submitted to the Agency for non-centrally authorised products . These clinical data continue to be made available to external requesters on a reactive basis in accordance with the aforementioned Agency’s policy on access to documents .
Reflection Paper Expectations Electronic Source Data Data ...
www.ema.europa.euWorking Group. The paper is intended to cover the creation/capture of electronic clinical data in all clinical trials in the EU/EEA or in third countries in case the clinical trial reports are submitted as part of Marketing Authorisation Applications to EU/EEA regulatory authorities. The requirements have their basis in Directive 2001/20/EC
CLINICAL REASONING (is this just one part of the process
www.utas.edu.auclinical problem that needs immediate attention and one that is less acute (del Bueno, 1994); and a tendency to make errors in time sensitive situations where there is a large amount of complex data to process (O‟Neill, 1994). In clinical practice experienced nurses engage in multiple clinical reasoning episodes for each patient in their care.