Clinical Endpoints Adjudication: a 5 steps process for a streamlined Assessment
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Clinical Endpoints Adjudication 5 steps for a streamlined online Assessment ADD NEW EVENT Here you can see the Adjudication Coordinator Repository where all the potential Endpoints are listed with their current assessment status. Let's start with the + ADD button to create a new event record.
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How Ethical eAdjudication supports Adjudication Coordinators and Independent Reviewers (CEC) with a simplified online process
Transcript of Clinical Endpoints Adjudication: a 5 steps process for a streamlined Assessment
Clinical Endpoints Adjudication5 steps for a streamlined online Assessment
ADD NEW EVENTHere you can see the Adjudication Coordinator Repository where all the potential Endpoints are listed with their current assessment status. Let's start with the + ADD button to create a new event record.
ADD POTENTIAL ENDPOINT EVENTHere the form to create a new Event.In this scenario the Adjudication Coordinator can add a new event interactively by filling in some fields custom defined for the Study..In other common software configurations the events are created through a direct integration of the eAdjudication platform with other systems like Safety databases, EDC or CTMS systems
EVENTS REPOSITORYAs soon as the Event is saved it appears in the Adjudication Coordinator Repository with the status "never submitted" to Reviewers
EVENT INFORMATION PACKAGEBefore submitting it to the reviewers the Coordinator could complete the event package with its key variables and documents.
In most cases the key variables come in the system through a direct integration (web services) with other data management already in place for the trial
ADJUDICATION COMMITTEE MEMBERSthe final step is the selection of the Reviewers and Chairman that form the Adjudication Independent Committee.
In many cases this operation can be automated using a predefined custom set of rules
COMMITTEE MEMEBERS ALERTINGas soon as a new event is submitted the Coordinator can use the "pending summary" function to send automated alerts to the Reviewers and Chairman and to invite them to review and assess the event.
ALERT EMAIL TO COMMITTEE MEMBERSThe Committee Members receive the Alert in their mailbox as an email message with some event references and a link to connect to the system
COMMITTEE MEMBER’S REPOSITORYwhen connected they can find the new event in their repository with the status “Submitted"
ADJUDICATION ASSESSMENT FORMThe reviewers can now go to the Assessment Form, customized with the questions to be answered as stated in the protocol.Here they can review the event package, read all the associated documents or images, and make consequently their assessment
ADJUDICATION ASSESSMENT FORMor they can instead ask for “More Data” if the event package information is judged not adequate
ADJUDICATION ASSESSMENT FORMthey can temporarily save the form values or finalize the assessment.In this case their “digital signature” is requested and archived together with the judgment.
The Adjudication is then applied to rule how the different reviewers' judgments are combined in a definitive assessment or if a “consensus meeting” is to be planned to solve disagreements among the Reviewers
Thank you,for more information about the Ethical eAdjudication® software, peculiarities & pricesplease visit: http://www.ethical.ch
Ethical eAdjudication – Clinical Endpoints Adjudication Software ver. 5.1 – [email protected] – http://www.ethical.ch
