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Analyze total answered query details

In Study Analytics, you can view different charts to get an instant insight into the current state of the EDC processes and entities, such as sites, subjects' phases, opened/answered queries, and so on. In the Total Answered Query bar chart, you instantly get information about the total number of queries that are answered but are yet pending review and approval from the sponsor and data manager (DM).

If you want to view a detailed analysis of the answered queries, then using this functionality, you can view summary details of the Total Answered Query chart and get information about each answered query, such as at which site and study the particular query exists, the form in which the query is added, the query type: system or manual, and so on.

To analyze the total answered queries' details

  1. In the EDC application header, select the DASHBOARD tab.

  2. On the page that opens, select the Study Analytics tab.

  3. From the Total Answered Query bar chart, select Go Details info_icon.png.

    Selecting option to view answered queries' details
    Figure 1. Selecting option to view answered queries' details

  4. On the page that opens, in the Total Answered Query table, analyze the subject details as explained in the following table.

    Total answered query details
    Figure 2. Total answered query details

    Element

    Details

    Record ID

    Represents the record identification number of a query that is based on the total count of the queries that are ever created or exist in the EDC application.

    For example, before you added your query, there already existed three queries in EDC. Regardless of whether the existing queries are closed, answered, or opened, the newly created query will be assigned the Record ID "4".

    Site Code

    Represents the site code in which the query exists.

    Subject ID

    Represents the identification code of the subject in which the query exists.

    Visit Name

    Represents the visit name in which the query exists.

    Form Name

    Represents the name of the eCRF in which the query is added.

    Record SN

    Represents the serial number of the eCRF form in which the query is added.

    Question

    Represents the eCRF question to which the query is added.

    Variable

    Represents the question variable in which the query is added, such as AETERM (adverse event term), TYPESEQ (type of sequelae), and others.

    Type

    Represents the query type that can be as follows:

    • System: signifies that the query is system-generated as a result/consequence of a process.

    • Manual: signifies that the query is created manually by a user.

    Query Topic

    Represents the query inquired by the system or the user.

    Creation Role

    Represents the role of the user who created the query, data manager (DM), principal investigator (PI), or others.

    Creation Date

    Represents the date on which the query was created.

    Assigned To

    Represents the user to whom the query is assigned.

    Pending Action From

    Represents the user from whom the action or answer to the query is required in order to close the query.

    Final Reply By

    Represents the user who provided the required answer to the query.

Once you have analyzed the answered query details, from the workspace toolbar, select switch_icon.png to go back to the Study Analytics page.

In this section:

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.