Workflow setting
In EDC, workflows are intended to dictate the procedure of the source document and payment request handling, introducing an additional tier of scrutiny and the approval or rejection mechanism to reduce the risk of unintended impact on sensitive resources and financial operations.
In this section, you can learn how to do the following:
A schema, each step of which represents a stage of a specific entity lifecycle in the system.
A workflow can be considered an instrument to help control various actions on system entities for the sake of accountability, as it limits the actions that can be performed on the entity associated with a workflow. This provides an additional tier of scrutiny, and the approval/rejection mechanism reduces the risk of unintended impact on sensitive resources and important information.
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For instance, in eTMF, the workflow dictates the procedure of file and folder management from the moment of upload to the approval stage; in CTMS, the workflow controls the process of creation, completion, and approval of a trip report; in EDC, the workflow covers the process of source document handling.
An original record or certified copy of a record that provides evidence of the existence, activities, or results of a clinical trial or study.
An example of the source document can be a paper case report form on which the subject data is collected before it is transferred into EDC in electronic format.