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Study management

In eClinical, studies are initially defined and configured in the ADMIN application. These studies are then assigned to different eClinical applications including EDC, eTMF, IWRS, and others, along with user groups that determine who can access and update the studies within these applications.

In CTMS, under the STUDY MANAGEMENT tab, you can work with the studies fetched from the ADMIN application and perform various configurations to manage and monitor your studies effectively, as outlined in the following table.

Configuration

Details

Basic study configurations

Perform basic actions to manage your study and its data, like viewing the study chart, updating the study's status, checking operation history, exporting the study to your computer, and much more.

My Work

Maintain, review, and estimate your workload and directly access all system tasks requiring your attention from the comprehensive study task dashboard.

Dashboard

Maintain a graphic visualization as an analysis tool to track the study processes. A comprehensive set of manageable charts covers different aspects of the study to display the statistics in an easily perceptible way.

Study details

Maintain the general study details, such as a site list, institutions, staff, and basic study information—study name, study type, therapeutic area, description, and more.

Project management

Review CPM and Gantt charts, maintain, manage, and define study milestones, master activities, deliverables, tasks, and more.

Financial management

Manage your study contracts, payment requests, prepare pricing templates and set up payment triggers.

RBM

Identify, assess, and mitigate the potential risks associated with the performance of clinical trials, such as protocol deviations, data discrepancies, and adverse events.

Monitoring

Manage and review monitoring and study data validation (SDV) activities—monitoring visits, trip reports, study data validation results report for all sites, subjects, visits, and forms pulled from EDC.

Data-driven monitoring

Perform the remote monitoring of the data pulled from EDC.

ICF

Track the distribution, collection, and status of Informed Consent Forms (ICFs) from participants in the trial.

Tracking logs

Create and manage customized tracking logs for key regulatory documents, such as Financial Disclosure Forms (FDF), Form 1572, and more.

Training

Track and manage study-related training documents to ensure team members are trained on key materials—such as protocol presentations, safety guidelines, and system instructions.

Protocol deviation

Define and manage various scenarios causing the divergence from the approved study protocol.

CRF status

Maintain and manage the case report form (CRF) statistics data pulled from EDC.

Query report

View the query status data pulled from EDC using the statistics provided in charts, tables, and other visualization tools.

Email report

Track the most up-to-date list of letters that have been sent to confirm or follow up on corresponding monitoring visits.

Documentation config

Build a unified configuration of the trip report file for your monitoring processes.

Alerts

Create reminders to notify recipients about various actions associated with the management and tracking of monitoring visits and queries.

Script-generated reports

Configure and maintain scripts for data extraction from eTMF and view the resulting report data.

Communication management

Schedule, organize, and monitor key communication activities, including any meetings or events throughout the clinical trial.
In this section:

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.

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 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.

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

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

An organizational unit of the ADMIN app that brings together certain users with similar responsibilities, activities, and purposes to conveniently manage their access rights by providing unified permissions to view and interact with selected sites and depots.

A document that provides essential information about a clinical trial to potential participants to ensure their complete understanding of the research nature, the risks and potential benefits involved, and their rights as participants.

Before enrolling in a clinical trial, participants must read and understand the information in the ICF, and signing the ICF indicates their willingness to participate, understanding that they have been fully informed about the study.

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