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System documents for data acknowledgment

Data acknowledgment before the end of the study is a process of confirming the receipt and accuracy of data and findings collected during a clinical trial.

In the EDC application, you can define the system documents that have to be acknowledged before the end of the study and then create individual tasks per each system document dataset to be acknowledged by the dedicated personnel.

The system documents for data acknowledgment in EDC are as follows:

Under the End of Study > System Document page, you can see the list of all currently existing tasks for data acknowledgment and their details explained in the following table.

Important

To access the System Document module of EDC, you need to have respective permissions granted to your user role via the ADMIN application:

  • Read: allows the user to see but not perform actions within the module.

  • Write: allows the user to see and perform actions within the module, such as downloading system documents.

  • Add: allows the user to see and perform actions within the module, such as creating system document acknowledgment tasks.

  • Delete: allows the user to see and perform actions within the module, such as deleting system document acknowledgment tasks.

System document list
Figure 1. System document list

Column

Details

Document ID

Represents the unique identification number of the system document associated with the data acknowledgment task.

Country Name

Represents the name of the country of the location of the sites where the data acknowledgment task must be completed.

Site Code

Represents the unique identification number of the site where the data acknowledgment task must be completed.

Status

Represents either of the following statuses of the task:

  • Not Started: the task has been created but not yet acknowledged by the assignee.

  • Acknowledged: the task has been acknowledged by the assignee but the system document(s) is not yet downloaded.

  • Completed: the task has been acknowledged and the system document(s) is downloaded by the assignee.

Creation Date

Represents the date when the data acknowledgment task is created.

Created by

Represents the name of the user who created the data acknowledgment task.

Assigned to

Represents the name of the user to whom the data acknowledgment task has been assigned.

CC

Represents the name of the user or the user role who is added as a receiver of the system document task notification but not made the assignee of the task.

From the System Document page, you can perform the following actions:

See also
In this section:

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.