Electronic storage of case report forms, all subsequent versions of case report forms and a log of changes to case report forms

'case':4,11,20 'chang':18 'electron':1 'form':6,13,22 'log':16 'report':5,12,21 'storag':2 'subsequ':8 'version':9

Computer software and hardware used to create, modify, maintain, archive, retrieve and transmit information in digital form related to the conduct of clinical trials

'archiv':10 'clinic':23 'comput':1 'conduct':21 'creat':7 'digit':16 'form':17 'hardwar':4 'inform':14 'maintain':9 'modifi':8 'relat':18 'retriev':11 'softwar':2 'transmit':13 'trial':24 'use':5

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