EF Clif – Aclara study
The challenge of a
international study with 50+ sites
Overview
The ACLF-ACLARA study will consist of a prospective follow-up observational investigation in 1300 patients with cirrhosis hospitalized for AD (Acute Decompensation) with and without ACLF in the 57 hospitals from the Latin America.
Marco Pavesi
/ Head Data Management Center – EF-CLIF
The EFClif is a private non-profit organization aimed to promote research and education in Chronic Liver Failure. The final objective of the Foundation is to improve the quality of life and to increase the survival of patients with liver cirrhosis.
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Requirements
Our solution
Complex observational study, with variable visits and repeatable sections depending on the type of patient.
Creation of the eCRF from the study protocol and the rest of the requirements defined by the customer. Close collaboration between EF-Clif and SCollect to adjust and validate the requested customisations and functionalities.
Extensive and complex data validation plan to ease monitoring and data management tasks
SCollect's architecture allows the creation of all kinds of validations with minimal effort, both in the setup of the eCRF and during the on going study. This feature, along with the queries system, makes data entry and study monitoring an easy task.
Help investigators in the management of their patients
Custom development to incorporate a new view in the patients list section. This view shows when are the subsequent visits scheduled for all the patients listed. The system also sends reminders to researchers.
Results:
An eCRF that is being used in 9 countries, 57 sites, with a total of more than 200 researchers using it.
Efficient release of eCRF amendment
Thanks to the technology, applied changes during the study are quickly incorporated in the eCRF.
Secure
All the communications are secured end to end using SSL encryption.
Custom
The study has some customisations of the eCRF specifically tailored to improve the processes of site personnel, data managers and monitors.
Technical support
The team at SCollect is responsible for solving all technical issues arising in the study.
Hosting
The study is hosted in Amazon Web Services (AWS) and is also managed by SCollect. We offer a complete service at a technical level; certificate management, database and server backups, load balancing, resource dimensioning and more.
