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CASE STUDY
The system is used for the logistic management and data management of
Phase III multi-center randomized (registration) study validated at a national
level.
The study is based on a specific drug, whose protocol requires the performance of one enrollment visit followed by the completion of a Randomization Form in the system that establishes the subject inclusiveness in the study and provides randomization code assignment.
The CRF - the protocol requires it to be quite articulated – includes
forms for all the planned visits, including periodical checks, as well as the forms for the registration of adverse events and of relapses, for statistical analysis purposes.
In addition to the usual data management issues, the specific study type implies the need to manage with absolute precision the
randomization code assignment to centers and patients following the positive outcome of the
inclusiveness verification in the study performed in the system.
There has been a big effort in the Validation process (related to the study’s registration nature) for the production of complete and accurate documentation both of the system and of all the processes related to the study management.
The system is based on a series of services that become accessible to the different users depending on their
profile/role within the study. Specifically, for the Giuliani implementation:
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the Sponsor has complete visibility of the system (browsing through all the functionalities)
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the Study Coordinator (C.r.o.) has complete visibility of the system, has responsibility/functionality of the Tracking entry and editing, and of randomization assignment within the study centers
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the Data Entry level I Operators edit the Clinical Data and visualize the Queries
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the Data Entry level II Operators have Query editing responsibility and can modify the CRF pages
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the Investigators
randomize through the appropriate form, with
browsing access to data relevant to the center
they belong to
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the Data Manager has access to the CRFs (through browsing mode only), edits and visualizes the Queries, and has access to reports
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the Statistician has complete visibility of the system in browsing mode to receive the data once the study is finished
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THE
Client
Giuliani was born in the remote
1889, when the first vial of the famous
Amaro Medicinale came out of the Lazzaretto drugstore.
Thanks to the company’s high-quality innovation and
scientificity, today Giuliani S.p.A. is
available in drugstores with a wide range of
products in the areas of health, beauty, and
comfort. |
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numBERS
37 centers
involved in the study with approximately
300 randomized patients |
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ACTIVATED FORMS
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ADMIN, general administration of the system |
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USER,
user profile |
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TRACKING, management of research projects |
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CLINICAL
DATA, data entry, randomization form and Patient Diary |
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QUERY, data analysis |
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RANDOMIZATION,
Patient Number assignment |
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S.A.E.,
Serious Adverse Events Management (in development) |
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STEERING COMMITTEE, Steering Committees management |
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DATA VIEW DOCUMENTATION, consultation of data collected |
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LABORATORY, visit and analysis management |
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REPORTS, publication of results |
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NOTES – Randomization questionnaire
Created ad hoc according
to the specific requirements provided by study protocol committee experts, it is a process with three phases:
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data
entry |
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confirmation form with registration results (Randomization/Failure) and chance of modifying the data in case of mistake |
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final Randomization/Failure report
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All the checks performed on the field values are restrictive and binding.At the end of the operations, the system may provide the Randomization final Report print-out on paper.
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e-crf
