Skip to main content

Audit contract

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 enable the contract audit—review and approval process performed by designated personnel.

Tip

The details of the auditing process are defined by the dedicated workflow that you preconfigure via the CTMS library.

The audit is applicable for the following objectives:

To audit a contract

  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. In Contract List that appears, locate the contract you want to audit. Then from the Action(s) column, select Audit list_icon.png.

    Selecting option to audit contract
    Figure 4. Selecting option to audit contract

    Tip

    Alternatively, open the contract details and on the page that opens, select audit_button_02.png.

    Selecting option to audit contract from details page
    Figure 5. Selecting option to audit contract from details page

  4. In the dialog that opens, audit the contract as follows.

You have audited the contract. The result differs upon the auditing objective and the performed action:

  • For submission withdrawal, the contract returns to the Draft status and can be edited or deleted.

  • For approval and signature of the newly created or amended contract version, the contract is validated and either moves to the next workflow stage or, once finalized, obtains the Active status. You can now handle payment requests in CTMS and manage site payments in EDC according to this contract.

  • For approval and signature of the contract termination, the action is validated and either moves to the next workflow stage or, once finalized, the contract obtains the Terminated status and is no longer valid for financial operations.

  • For workflow termination, the review and approval procedure is ceased. The contract returns to the Draft status and can be edited or deleted.

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.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

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.