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Open lab query

In the EDC application, a lab query is a request for clarifying, fixing, or otherwise addressing discrepancies in the data collected from the lab. This query is generated by the system or created manually by users when the lab data collected at the site does not come under the normal range, thus, creating uncertainties that need to be resolved.

Important

To open a lab query, you must have the respective system permission granted to your user role via the ADMIN application.

From Normal Range List, you can open a lab query in the following two ways—by category or by specific lab test.

Open lab query by category

With this functionality, you can create a request for clarification or fixes for the entire lab test category with all the lab test normal ranges within.

To open a lab query by category

  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane, select Lab > Site Normal Range.

    Accessing normal range list
    Figure 1. Accessing normal range list

  3. On the Normal Range List page that opens, next to the needed category, select More more_actions_icon.png > Open Query Open_query_dialog_icon.png.

    Opening query for category
    Figure 2. Opening query for category

  4. In the Lab Query dialog that appears, fill in the fields as explained in the following table.

    Adding query details
    Figure 3. Adding query details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Topic*

    Enter the details of the query being generated. Here, exhaustively outline your request or concern for the assignee to address.

    Expected Days*

    Enter the deadline in days for resolving the query being generated.

    Assigned to*

    From the dropdown menu, select the user role responsible for resolving the query being generated.

    SAVE

    Select save_button_red.png to save the implemented changes.

    CANCEL

    Select cancel_button_white_blue.png to dismiss without saving any changes.

Once saved, the query is added. The assignee is notified via email and can address the query.

Open lab query by specific lab test

With this functionality, you can create a request for clarification or fixes for the individual lab test and its normal ranges within the specific category.

Important

You can only open queries for quantitative tests as they have predefined normal ranges and might require clarification or amendment. Whereas qualitative and semiquantitative tests do not qualify to be queried as their values are either entered manually in CRFs or autopopulated by the system and have no quantitative value in question.

To open a lab query by a specific lab test

  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane, select Lab > Site Normal Range.

    Accessing normal range list
    Figure 1. Accessing normal range list

  3. In the Normal Range List table that appears, for the needed lab name, select Info info_icon_gray.png.

    Accessing site normal range details
    Figure 2. Accessing site normal range details

  4. On the Lab Data page that opens, under the Quantitative Test tab, next to the lab test in question, select Open Query Open_query_dialog_icon.png.

    Opening query for lab test
    Figure 3. Opening query for lab test

  5. In the Lab Query dialog that appears, fill in the fields as explained in the following table.

    Adding query details
    Figure 4. Adding query details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Topic*

    Enter the details of the query being generated. Here, exhaustively outline your request or concern for the assignee to address.

    Expected Days*

    Enter the deadline in days for resolving the query being generated.

    Assigned to*

    From the dropdown menu, select the user role responsible for resolving the query being generated.

    SAVE

    Select save_button_red.png to save the implemented changes

    CANCEL

    Select cancel_button_white_blue.png to dismiss without saving any changes.

Once saved, the lab query is added. The assignee is notified via email and can address the query.

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.

A laboratory test that measures the exact amount or concentration of a substance in a sample with the result being expressed as a precise numeric value, often with units of measurement, such as milligrams per deciliter, parts per million, and so on.

For instance, a blood glucose test is quantitative—it provides a specific numeric value for the concentration of glucose in the blood, such as 90 mg/dL.

A laboratory test that provides the assessment or measurement that produces categorical or descriptive results. An example of a qualitative test can be symptom assessment—evaluation of the presence, severity, or characteristics of a patient's symptoms using categorical scales, such as mild, moderate, and severe.

A laboratory test that provides approximate measurements of a substance, often yielding results in categories (for instance, normal and abnormal) or numerical ranges that are not highly precise. The example of semiquantitative tests can be urine protein tests, bilirubin levels, and so on.