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Home / Facilities / Data Collection

Data Collection

Advanced technological solutions to collect and manage clinical data, based on international standards, which guarantee interoperability, safety and ease of use.
Head: Ing. Tina Pasciuto
Email: datacollection@www.gemelligenerator.it
Description

The Data Collection facility offers services in the field of digital data collection. Our aim is to provide methodological, training, and analytical support to collect and manage research data in compliance with current Good Clinical Practice (GCP) standards, General Data Protection Regulations (GDPR) applying criteria of accuracy, data quality, completeness, consistency, integrity and timing (ACCIT). The facility is specialized in the creation of electronic Case Report Forms (eCRF), questionnaires and digital registers through a validated collection system, which allows secure data examination, automated data transfer, import and export; this favors the development of multi-center projects and simplifies monitoring and communicating of activities with supervisory or regulatory bodies.

Services of Data Collection
Training modules in collaboration with the Catholic University of the Sacred Heart

Collaborations with the academic component of the UCSC to create training modules within the university degree courses, focused on the research areas of the G2-ISC.

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Didactics on methodology, development and management of data collection

Training activities related to methodology, development and management of data collection for research purposes and the use of the RedCap application on both the user and developer side.

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Report production of punctual data and metadata

Reporting activities linked to timely data and metadata related to single or multiple projects, in compliance with GCP, GDPR and ACCIT criteria.

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Consultancy for data collection projects

Consultancy activities to support other institutions, bodies and organizations and to design and implement architecture or data collection projects and/or data quality assessment in compliance with GCP, GDPR and ACCIT criteria.

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Customized services to integrate RedCap standards

Ad hoc software development of modules to expand the standard application of RedCap, in compliance with GCP, GDPR and ACCIT criteria.

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Interoperability services between different data sources

Development of interoperability services between different data sources.

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Digitization and automatic reporting of adverse events (AEs) and severe adverse events (SAEs)

Digitization of the collection and automated communication of adverse events (AEs) and severe adverse events (SAEs) within the eCRF to streamline, standardize and optimize the relationship with regulatory bodies for interventional clinical trials.

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Digitalization, fusion and standardization of data collection

Digitalization, fusion and standardization of data collection from different sources in accordance with ontology, semantics and standardized syntax, in compliance with GCP, GDPR and ACCIT criteria.

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Data Import/Export/Transfer/Sharing

Activities of import, export, transfer and sharing of data related to projects developed with the RedCap application or any other similar technologies, in compliance with GCP, GDPR and ACCIT criteria.

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Data registry/digital archives

Development and management of data registers/ digital archives using the RedCap application or any other similar technologies, in compliance with GCP, GDPR and ACCIT criteria.

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Randomization

Development of randomization tables and centralized delivery using the RedCap application or any other similar technologies.

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Data entry

Data collection activities, in compliance with GCP, GDPR and ACCIT criteria, through professional figures with technical, scientific, managerial and organizational skills.

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Data quality

Evaluation and improvement of data collection quality through dedicated workflows and in accordance with the "ACCIT" (Accuracy Consistency Completeness Integrity Timeliness) criteria.

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Electronic survey

Development and management of electronic surveys for the collection of PRO (Patient Reported Outcomes) using the RedCap application or any other similar technologies, in compliance with GCP, GDPR and ACCIT criteria.

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Electronic Case Report Form (eCRF)

Development and management of eCRF for research data collection through RedCap application or any other similar technologies, in compliance with GCP, GDPR and ACCIT criteria.

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Methodological consultancy for Data Management/Validation Plans (DMP/DVP)

Support to design a data collection and management plan (DMP) and any other data validation plan (DVP) during the research project-planning phase, which complies with the GCP, GDPR and ACCIT criteria.

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Projects
BORN (umBilical blOod to tRansfuse preterm Neonates)
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Identification of a novel gene signature predicting response to first-line chemotherapy in BRCA wild-type high-grade serous ovarian cancer patients
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Miraggyo
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Morphonode Predictive Model
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The IMPROVEMENT study
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TOC-1
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Vulvar immunohistochemical panel (VIP) project: molecular profiles of vulvar Paget’s disease
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Team
Ing. Tina Pasciuto
Head, PhD
Paolo Casu
Senior data collection specialist
Dr.ssa Iolanda Mozzetta
Senior data collection specialist/ clinical data manager
Dr. Francesco Cicchillitti
Clinical data manager
Dr.ssa Ivana Conti
Clinical data manager
Dr.ssa Chiara Laurentaci
Clinical data manager
Dr.ssa Maria Marrazzo
Clinical Data Manager
Gabriele Placidi
Software Developer - System Integrator

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