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Review PD queries

A protocol deviation query is a request generated mostly by the data managers (DM) for clarification on some data items collected in CTMS upon protocol deviation record completion.

You can review a comprehensive report on all queries opened for PD records of your study in CTMS and track their current status, when they are opened, if they are resolved, and so on.

Tip

You can also export the query details if you prefer to work with the data offline.

To review the PD queries

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study management page that opens, from the left pane, select Query Report > PD Queries.

  3. On the PD Queries page that opens, review the details of all the PD queries opened in CTMS. The details of all the report columns are explained in the following table.

    Reviewing PD queries
    Figure 3. Reviewing PD queries

    Column

    Details

    Level

    Represents whether the PD query is at the site, subject, or study level.

    Site Code

    Represents the code of the site where the data being queried has been collected.

    Subject ID

    Represents the ID of the subject whose collected data is queried.

    Subject Status

    Represents the status (phase) of the subject whose collected data is queried.

    Visit

    Represents the name of the visit during which the PD query occurred.

    Record ID

    Represents the unique ID of the PD query if it was recorded at the subject level.

    Monitoring Visit Name

    Represents the name of the monitoring visit of the PD query.

    Question

    Represents the question text on the CRF to which the created PD query is related.

    Query Topic

    Represents the topic of the created PD query. The query topic usually explains the reason why the PD query has been added.

    Creation Role

    Represents the role of the user who created the corresponding PD query.

    Query by

    Represents the user account of the user who created the query.

    Creation Time

    Represents the time when the query was created.

    Creation Query Age (days)

    Represents the number of days since the query was created.

    Query Age (days)

    Represents the number of days since the query was assigned to the responsible user.

    Assign to

    Represents whether the query is assigned to Role or Assignee.

    Role

    Represents the role of the user who is responsible for the resolution of the query.

    Assignee

    Represents the name of the user who is dealing with the protocol deviation raised in the query.

    Query Status

    Represents the current status of the PD query.

    Overdue

    Represents whether the PD query is overdue or not.

    Final Reply Text

    Represents the last response text of the responsible user of the query.

    Final Reply by

    Represents the name of the user who last responded to the query.

    Closed Time

    Represents the time when the query was closed.

    Closed by

    Represents the name of the user who closed the query.

You have reviewed the details of all PD queries in CTMS.

See also
In this section:

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.