Contract management
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 and maintain contracts for your studies, reflecting different business scenarios and enabling financial operations, such as payment request management, to be performed within the system.
All the previously added contracts can be accessed via Financial Management > Contracts with their details as explained in the following table.
|
Column |
Details |
|---|---|
|
No. |
Represents a sequential number of the contract in the CTMS system. |
|
Contract Code |
Represents the unique identifier of the contract. This code is used in CTMS and EDC to distinguish between contracts when performing financial operations. |
|
Contract Name |
Represents the legal name of the contract. |
|
Contract Type |
Represents the type of the contract. Currently, only Clinical Trial Agreement is available for configuration in CTMS. |
|
Counterparty Name |
Represents the name of the vendor with whom the sponsor has entered the contract. |
|
Contract Amount |
Represents the total amount of money stipulated in the contract for all agreed services. |
|
Currency |
Represents the currency in which the payments must be made according to the contract. |
|
Signing Date |
Represents the date when the sponsor and the vendor have signed (entered) the contract. |
|
Contract Start Date |
Represents the date when the contract comes into effect. |
|
Contract End Date |
Represents the contract termination date. |
|
Contract Version |
Represents the currently effective version of the contract. Versioning is intended to track amendments to the contract conditions. |
|
Status |
Represents the current status of the contract according to the associated review and approval workflow set upon enabling audit.
|
|
Approval Status |
Represents the approval status of the contract at one of its stages as follows:
|
|
Created by |
Represents the name of the user who created the contract in CTMS. |
|
Created Date |
Represents the date, time, and time zone indicator when the contract is created in CTMS. |
|
Approved by |
Represents the name of the user who audited and approved the contract. |
|
Approved Date |
Represents the date, time, and time zone indicator when the contract is approved. |
From the Contracts page, you can manage your study contracts as explained in the following sections:
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 schema, each step of which represents a stage of a specific entity lifecycle in the system.
A workflow can be considered an instrument to help control various actions on system entities for the sake of accountability, as it limits the actions that can be performed on the entity associated with a workflow. This provides an additional tier of scrutiny, and the approval/rejection mechanism reduces the risk of unintended impact on sensitive resources and important information.
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For instance, in eTMF, the workflow dictates the procedure of file and folder management from the moment of upload to the approval stage; in CTMS, the workflow controls the process of creation, completion, and approval of a trip report; in EDC, the workflow covers the process of source document handling.