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Task management in EDC

PV uses the data of a specific subject collected and captured in CRFs via EDC. For PV to get the data extracted from EDC, the principal investigator (PI) of a site has to create a task via the EDC > Safety Gateway functionality and then send the data to PV.

Important

To access the Safety Gateway functionality in EDC, make sure you have all the required permissions granted via the ADMIN application. For more details, contact the EDETEK administrator.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

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.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

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.