clinical trial endpoint adjudication software - ethical eadjudication ®
DESCRIPTION
Adjudication of Clinical Endpoints is growing together with the spread of clinical trials based on subjective evaluations like imaging and adaptive design and the aim of supporting quality assessments by a central commitee of independent experts. These centralized evaluations of Clinical Events procedures are commonly implemented by sending to external experts some documentation about the clinical relevant events (event packages) and getting back their judgements in a blind way. Ethical e Adjudication ® is a Service based on a Cloud Portal software designed to support Study Leaders, Committee Members and the Q.A. Staff across the adjudication process providing the right tools/services to accomplish their assignment in a timely, effective and quality controlled way.TRANSCRIPT
SYSTEM REBRANDINGto be customized with the Customer’s image of choice
Ethical eAdjudicationClinical Endpoints Assessment Cloud Software
summary of system interfaces
Ethical eAdjudication – Clinical Endpoints Adjudication Software ver. 5.1 – [email protected] – http://www.ethcial.ch
STUDIES MENUshows the Studies to which the authenticated user is mapped on
ACCONT USERNAMEsystem page footer shows the authenticated username together with the connection IP address
SYSTEM SERVICESHelpDesk, User Account Profile, Log-Out
STUDY EVENTS REPOSITORYlists all the Events for the selected Study. The list can be sorted & filtered depending on event attributes or status. Shows different columns depending on User Profile
EVENT DETAILto access the Event Detail page for browsing or assessing the Event
EVENT AUDIT TRAILto access the Event Audit Trail with the complete Event history
EVENT USERSto access the Event Users page with the list of Users associated with this Event
STUDY FUNCTION BUTTONSto access the Notifications, Exports (SAS), Reports system sections
EVENTS LIST TOOLSto add an Event and to export the list in Pdf / Excel (csv)
KEY VARIABLES STATUS FLAGit’s about any change in the Event Key Variables after submission
DOCS STATUS FLAGalerts about any change in the Event Documentation after submission
COORDINATOR DASHBOARDuses button color to highlight the presence of some Alerts to be reviewed by the Coordinator
EVENT DETAIL SECTION 1 shows the Event Key Variables current value and their Audit Trail
EVENT DETAIL SECTION 2shows the Event current documents and their versioning with access to all the versions available
EVENT DETAIL SECTION 3the actual Assessment Form with custom fields, edit checks and workflows (also multiple pages)
EVENT DETAIL SECTION 4the Review’s Signature field to confirm the final assessment
EVENT AUDIT TRAILthe complete Audit Trail of an Event. Shows who, what, when, for every operation (export available)
EVENT OPERATION DETAILTo access the Versioning of the Event Assessment Values
EVENT ASSIGNMENT TO REVIEWERSthe complete history of an Event Submissions, Re-submissions and Assignement to Reviewers and Chairmen
COORDINATOR’S DASHBOARD ALERTSshows, when existing, system Alerts for special conditions like Events Never Submitted, Pending Assessments, Consensus Meeting queued for more than x days
COORDINATOR’S DASHBOARD GAUGESthey show Events figures and Event Status database composition
COORDINATOR’S DASHBOARD ACTIONSthey list Events for which an action is expected like More Data Requests and Consensus Meeting requests
COORDINATOR’S DASHBOARD MONITORSthe graphic of Pending Assessment distribution over the different Reviewers
REPORT CONSENSUS MEETINGSthe graphic and table showing the distribution of Consensus Meeting Attendance over the Reviewers
REPORT MORE DATA REQUESTSthe graphic and table showing the distribution of More Data Requests over the Reviewers
Thank you,for more information about the Ethical eAdjudication ® software, peculiarities & terminology
please visit: http://www.ethical.ch
Ethical eAdjudication – Clinical Endpoints Adjudication Software ver. 5.1 – [email protected] – http://www.ethcial.ch