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Create workflow

In the Library tab of the CTMS application, you can create custom workflows required for actions, such as to audit payment requests, contracts, trip reports, and potential protocol deviations. Based on the study protocol or sponsor's requirements, you can include a series of tasks in the workflow, which are then automatically executed by the system to complete a certain action.

For example, for processing payment requests, the tasks included in the workflow can be the following: Submit, Approve, Sign, and End. Thus, when a payment is submitted, then the system automatically sends a notification to the designated personnel to acquire their approval on the submitted payment. If approved, then the system sends another notification to the assignee to acquire their signature on the submitted payment. Once signed, only then the workflow ends, and the payment process is completed.

To create a workflow

  1. In the CTMS application header, select the LIBRARY tab.

  2. On the page that opens, from the left pane, select the Workflow Setting subtab (if not opened by default).

    Accessing workflow setting
    Figure 1. Accessing workflow setting

  3. On the Workflow List page that opens, from the workspace toolbar, select New Item add_new_icon.png. From the dropdown menu that appears, select one of the following options:

    • Trip Report Approval

    • Potential PD Approval

    • Contract Approval

    • Payment

    Selecting type of workflow to create
    Figure 2. Selecting type of workflow to create

  4. On the page that opens, enter the basic details of your workflow as explained in the following table.

    Entering basic details of workflow
    Figure 3. Entering basic details of workflow

    Tip

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

    Element

    Details

    Name*

    Enter a unique name for your workflow.

    Applicable Study*

    Select the study or studies in which you want to use the workflow you are creating.

    In the dropdown menu, turn the Apply to All toggle on or off. When off, you can choose a specific study for your workflow. Else, turn the toggle on to use the workflow in all the CTMS studies. Then select SAVE.

    Selecting study
    Figure 4. Selecting study

    Type

    Represents the type selected in step 3 of this procedure.

  5. Now in the workflow designer, start configuring the workflow by dragging the required task node from the left pane to the designer pane.

    The significance of the workflow task nodes is explained in the following table.

    Tip

    You may skip the configuration and proceed directly to step 10 to save your workflow. You can edit the workflow and complete the configurations later as needed.

    Dragging task to workflow designer pane
    Figure 5. Dragging task to workflow designer pane

    Important

    When designing the workflow, note the following:

    • The Trip Report Approval, Potential PD Approval, and Contract Approval workflows must have at least one Approve or Sign task node.

    • The Payment workflow can be created with only Start, Submit, Pay, and End nodes, meaning that its approval is handled during payment request audit in EDC, and in CTMS, you can directly pay the request.

    Element

    Details

    Start Start_icon_-_WF_task.png

    Represents the beginning of the workflow process.

    Whenever you create a workflow, this node is added by default. Also, the node is mandatory to add to every workflow.

    End End_icon_-_WF_task.png

    Represents the end or completion of the workflow process.

    Whenever you create a workflow, this node is added by default. Also, the node is mandatory to add to every workflow.

    Submit Submit_icon_-_WF_task.png

    Represents that an action has been submitted.

    For example, for a trip report processing in CTMS, when a report is submitted, then this task is executed.

    Whenever you create a workflow, this node is added by default.

    Approve Approve_icon_-_WF_task.png

    Add the node to your workflow if, at a certain point, the action requires approval from designated personnel, such as a data manager (DM), principal investigator (PI), or others.

    For example, after the trip is submitted, you may require approval for your report from DM.

    When you add the node, then by default, the Judge node is also added with the Approve node. This is because every approval can have two possible outcomes: approved or rejected. The Judge node provides you with the following options:

    Sign Sign_icon_-_WF_task.png

    Add the node to your workflow if, at a certain point, the action requires a signature from designated personnel, such as a DM, PI, or others.

    For example, after the trip report has been approved, you may require the PI to sign it.

    When you add the node, then by default, the Judge node is also added with the Sign node. This is because either the designated personnel can provide their signature on the action or not. The Judge node provides you with the following options:

    Co-sign Cosign_icon_-_WF_task.png

    Add the node to your workflow if the action requires a signature from multiple designated personnel, such as the DM, PI, or others.

    Note that the Judge node is automatically added along with the Co-sign node and provides you with the following options:

    This node is available for workflows of the Trip Report Approval, Potential PD Approval, and Contract Approval types.

    Pay pay_wf_node_icon.png

    Add the node to your payment approval workflow to reflect the stage of issuing the financial compensation, who is in charge of it, and the other details.

    This node is available for workflows of the Payment type. This node is added to the workflow designer by default.

    Judge Judge_icon_-_WF_task.png

    Represents tasks that can have successful or unsuccessful outcomes. This node includes Y (yes) and N (no) task nodes, using which you can define the corresponding task to execute when the task linked to the Judge node is successfully completed or it is unsuccessful, respectively.

    For example, once the trip report goes to the approval stage, the assignee can judge whether to approve or reject the report and, based on their judgment, the workflow dictates the following step—signature for a successful outcome or back to submission for rejection.

  6. Once a task node is added, link it to the required node by hovering over the node that you want to link (input node) and using the gray dots that appear to connect it to the desired output node.

    Linking workflow task nodes
    Figure 6. Linking workflow task nodes

    Important

    There are some restrictions for node linking:

    • The Start node cannot be targeted by any other node's linking arrow. This ensures that the workflow does not restart over and over getting into a loop.

    • The End node cannot target any other node with the linking arrow. This ensures that the workflow is finalized and does not trigger any processes once all the stages are passed.

    • The Submit, Approve, Sign, and Co-sign nodes cannot have only one consecutive node after them. This ensures that these types of operations have the Judge and at least one more stage after them.

  7. For the Judge node, link the Y and N nodes—that represent successful and unsuccessful completion of the associated task—separately as follows:

    1. Select either Y or N node as required.

    2. Hover over the Judge node and select the gray dot that appears to connect it to the desired output node.

      For example, as shown in the following figure, the link is added for ending the workflow when the action is approved.

      Linking Judge node example
      Figure 7. Linking Judge node example

  8. After the task nodes are linked, add or modify details for the Submit, Approve, Sign, and Co-sign task nodes (if added). To add the details, double-click the task node or select the task node and then from the workspace toolbar, select Edit pencil_icon.png.

  9. In the panel that expands, configure the task node details as follows.

  10. Once you have designed the workflow, from the workspace toolbar of the workflow designer, select Save save_icon.png.

    Saving workflow
    Figure 13. Saving workflow

Once saved, the workflow is created. You can now use it for trip report, protocol deviation, contract, or payment request management in CTMS.

In this section:

In a clinical trial, a document that describes the objectives, design, methodology, statistical considerations, and aspects related to the organization of a study.

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.