Case Study
The system is in the release phase and will be used for the logistic and data management of a
substudy of a Phase III, multicenter study.
This is a study that involves the collection of medical reports from the various participating centers, and the reading and electronic detection through import by automatic analysis systems,
directly into the CTDMS system through a specific validated
procedure.
The study needs to trace the logistic path of media and specimens, and the implementation of a specific
planner for the display of the state of operational progress of the centers/patients is being prepared.
The activated modules will include advanced data management functions:
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User Authentication and
Profiling, to control user access, recognition and profiling functions (enabling of the functions and access to related data) and the management of user credentials for accessing the system
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Tracking,
for the logistic control and registration activities linked to carrying out the study and the management of the relevant registries
(centers/patients/documents/materials)
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Clinical Data,
for the activities of display and manual changes to the clinical data in the relevant digital CRF
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Query,
for search, issue, display, change and management of the queries relative to the data entered in the digital CRF
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Data Import,
for the upload and import activities in the system of the Clinical Data extracted from the medical reporting systems, as documented in the attached specifications
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Data Cleaning,
for the activities of detecting errors and issuing warnings to the data manager regarding Clinical Data, following import operations into the system
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Data Export,
for export activities from the system of the Clinical Data at the end of the data acquisition and management operations
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Help Desk,
for the activities of requests and tracking requests for technical-operative support to the users of the system
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The Customer
The Salvatore Maugeri
Foundation was founded in 1965 to support the activity of the Institute of Occupational Medicine of the University of Pavia.
Starting with the original group constituted at the Pavia Center, over time the Fondazione organized an integrated set of structures for various forms of hospitalization, including hospital stays, day-hospital, outpatient treatment and
applied biomedical research.
The Fondazione operates institutionally by linking clinical and environmental activities with research, with a constant production of scientific works published in the most qualified national and international journals.
Currently, the group operates in numerous clinical
locations, and three Prevention
Centers, distributed throughout the national territory. |
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THE
numBerS
120 Centers are participating in the study
Approximately 730 patients are expected |
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NOTES
- The logistic tracking form
Specific forms will allow for tracking the movements of the medical reports.
A specific planner will at all times display the state of progress of the different centers/patients with respect to the operational flows in the study.
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e-crf
