SirER Platform

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Features and functions

The Emilia-Romagna Health Research Information System platform (SirER) is a web environment dedicated to the management of the authorization process and to the monitoring of clinical research processes in the regional context. In particular, SirER collect data on research activities carried out in Emilia-Romagna Region and, at the same time, promote a uniform management of the activities of competence of the Ethics Committees (EC) secretariats and of the research and innovation infrastructures of the Local Health Trusts and of the Universities of Emilia-Romagna.

SirER platform provides:

• Differentiated accesses to resources (forms, ...) according to the user's profile.
• Documents management in all phases of the research protocol life cycle.
• Validation in real time of the entered data.
• Ability to produce predefined and customized reports.

Platform use is mandatory.
With the exception of: experimental studies with medication, pursuant to the European regulation 536/2014 dated 16^th April 2014, which require the uploading on CITIS platform (Clinical Trials Information System) of the one Eu clinical trials platform.

The platform was launched on 1st March 2020.

Target users

SirER platform is set up for professionals involved in the submission, authorization and monitoring phase of a clinical study. Specifically, it is used by: researchers of the Regional Health Service (SSR), Sponsors, contract research organization (CRO), principal investigator (PI), clinical trials coordinator, research and innovation offices, system administrator (data manager), pharmacies, Ethics Committee secretariats, Ethics Committee members.

The Ethics Committees

The ethics committees of Emilia-Romagna region have been reorganized by the Regional Council Resolution n. 2327 dated 12/21/2016:

• The Ethics Committee of Vast Area of North Emilia (CE-AVEN) includes: Piacenza Health Trust, Parma Health Trust, Parma University medical Trust, Reggio Emilia Health Trust, Reggio-Emilia Scientific Institutes for Research and comprehensive Healthcare (IRCCS), Modena Health Trust, Modena University medical Trust, University of Parma, University of Modena and Reggio-Emilia.
• The Ethics Committee of Vast Area of Central Emilia (CE-AVEC) includes: Bologna Health Trust, Bologna University medical Trust, Ferrara Health Trust, Ferrara University medical Trust, Imola Health Trust, the Scientific Institutes for Research and comprehensive Healthcare (IRCCS) Neurological Sciences Institute of Bologna and the Rizzoli Orthopedic Institute of Bologna, University of Bologna, University of Ferrara.
• The Ethics Committee of Vast Area of Romagna (CEROM) includes: Romagna Health Trust and the Scientific Institutes for Oncological Research and comprehensive Healthcare (IRCCS) of Meldola.

Contacts

For information or assistance on: platform operation and malfuncions, profiling and access, legal-administrative issues and general or specific information on studies submission.