Skip to main content

Script-generated reports

Script-generated reports are configured to extract data from eTMF files and provide a convenient table-view data representation in CTMS. The data extraction is performed according to your configurations from the respective uploaded R script, hence the name—script-generated reports. This functionality might become useful for sponsors who use an external EDC system and want to extract the data from there and review it via eClinical CTMS.

The general procedure of report generation is as follows:

  • The source data is extracted from an external system by the EDETEK data manager team.

  • The source data file is uploaded to the respectively configured eTMF directory.

  • The report configuration is added to CTMS based on the R-script file provided by the sponsor or EDETEK.

  • The system starts running the R script and extracting data uploaded to eTMF, converting it into a convenient table-view report in CTMS.

  • The CTMS system autostores R outputs in eTMF to avoid any outputs lost.

Important

If you want this functionality configured for your study, contact the EDETEK administrator to set the appropriate parameters in the eClinical system.

In this section, you can learn how to do the following:

In this section:

An electronic version of a trial master file (TMF) is a type of content management system for a clinical trial used to organize and store files required for compliance with government regulatory authorities like the FDA, EMA, or others.

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

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.

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 managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.