Reply To: 10.03.01 – Database Requirements

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#4566
Janna Gonzalez
Participant


Definitions.
To provide a detailed design framework for
the system(s) used to manage and store
subject/patient data captured via a paper
CRF or eCRF for the specified trial. Not to be
confused with specifications for the Electronic
Data Capture (EDC) system (see 10.04.02).
Reason for change:
Clarification”