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Enable/Disable contract audit

A contract is an agreement between the sponsor and the vendor for certain services to be financially compensated on the established terms.

In CTMS, you can create contracts with counterparties, reflecting different business scenarios and enabling financial operations. To validate the contract and ensure all the details are properly defined, you can introduce an audit—review and approval process performed by designated personnel. The details of the auditing process are defined by the dedicated workflow that you preconfigure via the CTMS library.

Thus, by enabling the audit and assigning a specific workflow, you establish a mandatory and specific procedure for every contract validation of your study. However, if the contracts of your study do not require any review and approval mechanism, you can disable the auditing.

To enable or disable a contract audit

  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 page that opens, in the left pane, select Financial Management > Contract.

    Accessing contract list
    Figure 3. Accessing contract list

  3. From the workspace toolbar of Contract List that opens, select Contract Configuration Gear_icon_gray.png.

    Accessing contract audit setting
    Figure 4. Accessing contract audit setting

  4. In the Contract Configuration dialog that opens, set up the auditing procedure as explained in the following table.

    Enabling audit for contracts
    Figure 5. Enabling audit for contracts

    Tip

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

    Element

    Details

    Clinical Trial Agreement Setting

    Need to be Approved

    Control the toggle as follows:

    • Turn on the toggle to enable the auditing procedure for the contracts of your study.

    • Turn off the toggle to disable the auditing procedure.

    Workflow Name*

    Select the contract approval workflow according to which all the contracts of your study must be reviewed and approved.

    SAVE

    Select save_button_white_red.png to implement the changes.

    CANCEL

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

Once saved, the auditing procedure for your study is either enabled or disabled based on your performed action.

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 client’s partner company represented by an automated system that derives clinical data and sends it to, or receives it from the eClinical system.