Overview

Discrepancy Notes (DN) is a tool to manage queries or add more meaning to data fields of study subjects.

Via Discrepancy Notes, users responsible for data entry or data monitoring can communicate and resolve problems relating to data in the study

Contents:

Types of Discrepancy Notes

Type of DN	Purpose
Failed Validation Check	Used to mark data which does not conform to data entry rules in study protocol
Query	Used to communicate problems with data in data quality control
Reason for Change	Used to mark reason for updating a visit CRF whose data entry has been marked as completed.
Annotation	Provide additional information or annotate data

Discrepancy Notes Statuses

For DN used to provide additional information such as Reason for Change and Annotation, statuses are not applicable ( )

DN which requires revision and update of such as Failed Validation Check or Query has 4 statuses:

Status	Symbol	Meaning
New		The default status at creation of Query or Failed Validation Check
Updated		Được sử dụng để phản hổi lại lại DN nhưng cần theo dõi thêm hoặc cần thêm thông tin Used to respond to a DN which needs more supervision or information
Resolution Proposed		Used to mark data as updated or provide reason as to why the data is incorrect. A monitor or data manager needs to review and mark the DN as 'Updated' if more information is needed or 'Closed' if the query has been resolved.
Closed		Final status of "Failed Validation Check" or "Query"; used to confirm that the query has been reviewed and resolved

Data fields of a discrepancy note

Field	Meaning	Filling instructions
Description	Description of DN can be a question or a comment	Maximum 255 characters
Detailed Note		Maximum 1000 characters
Type	Kiểu Discrepancy Note	Select from one of the following DN: Failed Validation Check Query Reason for Change Annotation
Set to Status	Status of DN after updating	With DN of type Failed Validation Check or Query, select from one of the following: Failed Validation Check Query Reason for Change Annotation For other DN types, the default is Select from one of the following DN: Failed Validation Check Query Reason for Change Annotation
Assign to User	Assign user to answer query (Only applies to DN of type query)	Select one user from list
Email Assigned User	Email assigned user (Only applies to DN of type query)

Interacting with DN

From any data fields of visit CRFs, some data fields of visits, users can interact with Discrepancy Notes of that data field.

Discrepancy Notes in Visit CRF

When there are no discrepancy notes, the icon is (). When DN exists, the icon changes to the corresponding status icon.

To interact with DN user needs to click on the icon of the corresponding data field.

Layout to interact with DNs of a data field

The Discrepancy Note page consists of:

Information on the current data field

History of interaction with DN of data field

Create new DN

In the event that no DN has been created, choose 'Begin New Thread' to show the Create New DN dialogue.

Update DN of Failed Validation Check or Query type

In the workflow of DN of type Failed Validation Check or Query which has not been closed, usr can update its status to 'Update', 'Proposed Resolution' or 'Closed'.

Process of Working with Failed Validation Check

Failed Validation Check is used to mark data which does not conform to data entry rules in study protocol.

Create DN of type Failed Validation Check

During data entry when an error is automatically detected via the Edit Check tool, the data entrant can save the data twice without updating the data for the system to automatically create failed validation checks.

During data entry, if data entrant finds problems, they can also create Failed Validation Check to mark the problem.

2. Review and resolve DN

A monitor or data manager can review problems related to the DN. After reviewing the data, those users can mark the DN as:

Updated Notes: mark information to be reentered or clarified
Closed: DN is closed and the data is correct and usable

Process of Working with Query

During data monitoring, especially monitoring SDV, if any problems arise with the data, a monitor can create a query to require the data entrant to edit the data.

Create DN of type Query

A query can be created if a monitor finds a mistake. A monitor can assign an user to resolve the query

2. Resolve the query

User with data entry rights will review the data and update or explain the current data.

3. Review the data after query is resolved

A monitor or data manager can review problems related to the DN. After reviewing the data, those users can mark the DN as:

Updated Notes: mark information to be reentered or clarified
Closed: DN is closed and the data is correct and usable

Monitoring discrepancy notes via Discrepancy Notes Page

The layout of this page is as follows:

Discrepancy Notes Summary: Summarizes DNs by type and statuses

Pagination

Filter: Filter and search DNs by criteria

Discrepancy Notes Table: Each row corresponds to each DN and has 2 action buttons to view or access the data field with the DNs directly

Monitoring discrepancy notes via Task Summary

CheckPad allows user to monitor discrepancy notes via Task Summary. Read more on Task Summary here.

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