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Query management in document warehouse

For the files uploaded to the document warehouse, you can open queries to request clarifications, resolve uncertainties, or for other reasons. Queries provide clear and traceable way of communication, aiding the transparency of study files management.

Once you open the Document Warehouse file storage, you can see the query panel that depicts how many queries in different statuses are assigned to you. The details of the query panel are explained in the following table.

Query panel in document warehouse
Figure 1. Query panel in document warehouse

Element

Details

My Open Query my_open_query_icon_green.png

Represents the number of open queries assigned to you and awaiting for your reply.

My Answered Query my_answered_query_icon_green.png

Represents the number of queries opened by you that have already been replied by the assignee.

My Overdue Open Query my_open_overdue_query_icon_green.png

Represents the number of open queries assigned to you that are past their expected due date set upon opening the query.

My Overdue Answered Query my_answered_overdue_query_icon_green.png

Represents the number of queries opened by you that are past their expected due date and are answered by the assignee.

In Document Warehouse, you can manage your queries as discussed in the following sections.

Open query for file in document warehouse

In eTMF, the Document Warehouse tab is mainly used for the temporary storage of some unorganized files so that, upon request, they can be organized by data managers (DM) and other accountable individuals per DIA RM and uploaded to the Essential Documents storage.

While the files are stored in the document warehouse, you can open queries on them to request clarifications, resolve uncertainties, or for other reasons.

Important

To open queries, you must have the Document Warehouse > Open Query permission granted to your user role via ADMIN.

To open a query for a file in the document warehouse

  1. In the eTMF application header, select the TMF tab.

  2. In the Study List that opens, from the table, select the name of the study for which you want to access the document warehouse.

    Selecting study
    Figure 1. Selecting study

  3. From the left pane, select the Document Warehouse subtab. If required, from the study selection field, you can change another study.

    Accessing document warehouse and study
    Figure 2. Accessing document warehouse and study

  4. From the explorer tree panel, select the directory containing the file for which you want to open a query.

  5. Locate the file and from the Actions column next to it, select More more_icon.png > Open Query query_icon.png.

    Selecting option to open query
    Figure 3. Selecting option to open query

  6. In the Open Query dialog that opens, fill in the fields as explained in the following table.

    Opening query in document warehouse
    Figure 4. Opening query in document warehouse

    Tip

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

    Element

    Details

    Topic*

    Enter the descriptive topic of your query that you want the assignee to address.

    Query Expected Days*

    Enter the number of days to define the query expiration period.

    You can set the expected days value for all your queries with the Study Configuration feature. Then the number is predefined upon opening a new query. Nevertheless, it is always editable.

    Assigned to*

    Select to whom you want to address the query—a specific group of users with the same scope of responsibilities and access rights (Role) or a certain person or people (Assignee).

    Role*

    Select the user role to whose representatives you want to address your query. This field becomes available if Role is selected in the Assigned to field.

    For instance, if you need someone to check the file against the source document, you can select the CRC role here as they work at sites and have access to subject data in source documents.

    Keep in mind, that the user role with which you currently operate the system is unavailable in the list. Thus, you cannot open a query assigned to yourself. For example, if you are logged in as CRC, the CRC role is missing from the list.

    Assignee*

    Select the name of the users to whom you want to address your query. This field becomes available if Assignee is selected in the Assigned to field.

    For instance, if you need someone to check the file against the source document at a specific site and you know the person working there, you can select their name here and they will address your inquiry.

    Keep in mind, that your own user name is unavailable in the list. Thus, you cannot open a query assigned to yourself.

    SAVE

    Select save_button_red.png to implement the changes.

    CANCEL

    Select cancel_button_black_white.png to discard the changes and close the dialog.

Upon saving, the query is open and a respective icon open_query_blue_icon.png appears next to the file name. Now, the assigned users receive and can reply to the query.

Edit query for file in document warehouse

For the files uploaded to the document warehouse, you can open queries to request clarifications, resolve uncertainties, or for other reasons.

The previously opened query can be edited if there is a need for some adjustments.

To edit a query for a file in the document warehouse

  1. In the eTMF application header, select the TMF tab.

  2. In the Study List that opens, from the table, select the name of the study for which you want to access the document warehouse.

    Selecting study
    Figure 1. Selecting study

  3. From the left pane, select the Document Warehouse subtab. If required, from the study selection field, you can change another study.

    Accessing document warehouse and study
    Figure 2. Accessing document warehouse and study

  4. From the explorer tree panel, select the directory containing the file for which you want to edit a query.

  5. Locate the file with the query and next to the file name, select Open Query open_query_blue_icon.png.

    Accessing query to edit
    Figure 3. Accessing query to edit

  6. In the Query List panel, next to the query you want to update, select Edit pencil_icon.png.

    Selecting option to edit query
    Figure 4. Selecting option to edit query

  7. In the Edit Query dialog that appears, update the details as needed. These details are identical to those explained in the table of the Open query for file in document warehouse section.

    Editing query details
    Figure 5. Editing query details

  8. Select save_button_red.png to implement the changes.

Once saved, the query is updated.

Reply to query for file in document warehouse

For the files uploaded to the document warehouse, you can open queries to request clarifications, resolve uncertainties, or for other reasons.

The query is always addressed to a certain assignee or a group of users of the same role who have to answer the question, perform needed actions, or otherwise address the query topic. In eTMF, you can reply to the open query to provide your feedback. Queries with their replies provide a traceable way of communication, aiding in resolving issues with files.

Important

To reply to queries, you must have the Document Warehouse > Reply Query permission granted to your user role via ADMIN.

To reply to a query for a file in the document warehouse

  1. In the eTMF application header, select the TMF tab.

  2. In the Study List that opens, from the table, select the name of the study for which you want to access the document warehouse.

    Selecting study
    Figure 1. Selecting study

  3. From the left pane, select the Document Warehouse subtab. If required, from the study selection field, you can change another study.

    Accessing document warehouse and study
    Figure 2. Accessing document warehouse and study

  4. From the explorer tree panel, select the directory containing the file for which you want to address a query.

  5. Locate the file with the query and next to the file name, select Open Query open_query_blue_icon.png.

    Accessing open query
    Figure 3. Accessing open query

  6. In the Query List panel that opens, expand the query of your interest by selecting arrow_right_icon.png. Then in the Reply field, enter the message to address the query topic and select grey_check_icon.png to save the reply.

    Replying to query
    Figure 4. Replying to query

You have replied the query.

Close query for file in document warehouse

For the files uploaded to the document warehouse, you can open queries to request clarifications, resolve uncertainties, or for other reasons.

The previously opened query has to be closed once the query topic is addressed. Closing the query means confirming the resolution of the issue in a traceable way, aiding in transparent study document handling.

To close a query for a file in the document warehouse

  1. In the eTMF application header, select the TMF tab.

  2. In the Study List that opens, from the table, select the name of the study for which you want to access the document warehouse.

    Selecting study
    Figure 1. Selecting study

  3. From the left pane, select the Document Warehouse subtab. If required, from the study selection field, you can change another study.

    Accessing document warehouse and study
    Figure 2. Accessing document warehouse and study

  4. From the explorer tree panel, select the directory containing the file for which you want to close a query.

  5. Locate the file with the query and next to the file name, select Open Query open_query_blue_icon.png.

    Accessing open query
    Figure 3. Accessing open query

  6. In the Query List panel, next to the query you want to update, select Close close_icon.png.

    Selecting option to close query
    Figure 4. Selecting option to close query

  7. In the confirmation dialog that appears, select yes_button.png to close the query.

    Confirming query closure
    Figure 5. Confirming query closure

Upon confirmation, the query is closed, and the icon next to the file name changes to Closed Query closed_query_icon.png.

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.

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.

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 person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.