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EDC/e-CRF
The experience achieved in the management of pre- and post marketing clinical study projects, integrated with Internet technology, has enabled us to develop a highly functional system, flexible towards the Sponsor’s needs, reliable and safe, which, in compliance with rules in force (Guidance for Industry, 21 CFR Part 11):
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is validated in order to guarantee its accuracy and reliability and its capacity to recognize non-valid or altered records; |
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allows the generation of accurate and complete copies of all the records, both on paper and on magnetic support; |
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allows suitable protection of the records entered, so that they can be retrieved accurately and completely at any time during their conservation time; |
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offers an access limited to authorized users (username/password); |
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can keep an audit trail, that is a magnetic record, with time trail, of data enter, change, record creation or erasing, with the possibility to go back to the user who carried out the operation and to the moment (date, time) when the operation was carried out. |
Functionality: the application of Internet technology to research projects offers various advantages in terms of user’s friendliness and easy electronic data collection form fill-in (e-CRF), readiness in the transmission of the latter, easiness and readiness of communication among the different actors involved in the research project.
Flexibility: the EDC system involves the personalization of web pages ad hoc on the research project. The maximum compliance with the Investigator and Sponsor’s needs is therefore always guaranteed.
Reliability: the transmitted data are automatically made available on the project database, thus reducing potential risks at data entry stage.
Security: security level C2 as per US Defence Department’s definition (controlled access, univocal user identification, audit operations on events connected to security limited to authorized system administrators, protection against external interference or attacks).
Advantages of the EDC system
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Real time transfer of the data in the database, without transcriptions, with immediate access to all the data collected |
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Centralization of information |
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On-line checks for completeness, consistency and reliability of data |
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Improvement in data quality and reliability and reduction in the number of queries |
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Timely query generation and resolution, acceleration of the processes aimed at their notification and resolution |
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Timely discovery of fraud, bad quality of data and inaccurate data entry |
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Possible remote monitoring, with reduction in the number of visits and increased attention to other activities: Centre management, query generation/solution, check of study documentation, SAE |
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Improved communication with the Centres |
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Better control and management of the study, with updated reports on the patient recruitment by Centre, on the visits carried out by patient, on lab nominal value or on SAEs |
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Investigator’s activities made easier: on-line help-desk, pull-down menu, on-line availability of reference documents, automatic notifications |
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Increased efficiency of research activities
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Chart: time saving
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Chart: increased data quality |
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