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Create 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, such as payment request management, to be performed within the system.

Important

Before creating a contract, make sure to add a pricing template for it first.

To create 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. From the workspace toolbar of the Contract List table, select New Item add_new_icon.png. Then select Clinical Trial Agreement.

    Selecting option to create new contract
    Figure 4. Selecting option to create new contract

  4. In the form that opens, complete the contract details as explained in the following table.

    Completing contract details
    Figure 5. Completing contract details

    Tip

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

    Element

    Details

    Basic Information

    Contract Code*

    Enter the unique identifier to distinguish your contract in CTMS and EDC systems when performing financial operations.

    Contract Name*

    Enter the legal name of the contract.

    Signing Date*

    Select the date when the counterparties signed the contract.

    Contract Date*

    Select the start and end dates of the contract effectiveness.

    Contract Owner*

    Enter the name of the legal contract owner.

    Contract Version

    Represents the version of the contract. Upon first creation, the V1 version is assigned.

    Attachment(s)

    upload_icon.png

    Select the upload symbol to attach a file relevant for the contract. You can attach as many files as needed.

    Delete

    Select x_icon.png next to the attachment to remove it from the contract.

    Counterparty Information

    Site(s) Info*

    Country / Region*

    Select the country or region where the site with which the contract is entered is located.

    Site Code*

    Select the code of the site with which the contract is entered.

    Overhead Rate

    Enter the percentage that must be added to the direct price of each service at the site to compensate for some indirect costs, such as labor, machine hours, and so on. By setting an overhead rate for the site, you automatically include these expenses in all payments made to its recipients.

    Site Name

    Represents the name of the site with which the contract is entered.

    This value is autopopulated from the site profile based on the selected site code.

    PI Name

    Represents the name of the principal investigator (PI) at the site.

    This value is autopopulated from the site profile based on the selected site code.

    PI Email

    Represents the contact email of the PI at the site.

    This value is autopopulated from the site profile based on the selected site code.

    PI Mobile

    Represents the contact phone number of the PI at the site.

    This value is autopopulated from the site profile based on the selected site code.

    CRO Info

    CRO Institution*

    Select the clinical research organization (CRO) name with which the contract is entered.

    The institutions available for selection here are populated from the study institution list.

    Agent Sponsor*

    Specify if the CRO is an authorized agent of the sponsor with certain contractual or operational responsibilities (Yes) or not (No).

    Contract Person

    Select the name of the person who is a contractual representative of the CRO institution.

    The names available for selection here are populated from the study staff list.

    Role

    Represents the role of the contract person at the institution, such as CRA, PI, and so on.

    The value is autopopulated with the contract person's details pulled from the study staff list.

    Email

    Represents the contact email of the contract person.

    The value is autopopulated with the contract person's details pulled from the study staff list.

    Mobile

    Represents the contact phone number of the contract person.

    The value is autopopulated with the contract person's details pulled from the study staff list.

    Add Content

    Select plus_icon.png in the Site(s) Info or CRO Info blocks to add a new row and provide more site or institution contact details.

    Remove

    Select minus_circled_icon.png next to the rows of the Site(s) Info or CRO Info blocks to remove extra rows with site or institution contact details.

    You can remove sites upon configuration, however, once the contract is audited and obtains the Active status, you cannot remove sites from it.

    Financial Information

    Contract Amount*

    Enter the amount of money stipulated in the contract for all agreed services.

    Study Currency*

    Represents the currency of the financial operations of your study autopopulated from the study basic information in CTMS.

    Pricing Currency*

    Select the currency in which the payments must be made according to the contract.

    Exchange Rate

    Enter the exchange rate between the study currency and the pricing currency if you want to establish a set exchange rate for all the financial operations according to the contract. If left blank, you can specify the exchange rate when creating the payment requests.

    This field is only available if the study currency is different from the pricing currency.

    Tax Rate %

    Enter the tax rate, if applicable to the financial operations, according to the contract. You can enter up to five decimal places for the tax rate precision.

    Pricing Template*

    Select the pricing template preconfigured for your study to outline billing details of the contract.

    The pricing templates available for selection here are those with the currency matching the selected pricing currency.

    Template Version*

    Select the version of the pricing template you want to associate with the contract.

    SAVE

    Select save_button.png to implement the changes.

Once saved, the contract is created in the Draft status and you now need to submit the contract.

The Overall Budget block appears with billing details derived from the selected pricing template and the amounts specified in the contract. By selecting Fee Breakdown money_icon.png, you can also see the details of various categories of services to be paid according to the contract.

Analyzing overall budget of created contract
Figure 6. Analyzing overall budget of created contract

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.

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.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.