The Imigastric Data Entry System
A system of online submission and sharing of patient’s data through a dedicated and protected website was planned.
LOGIX S.r.l. created a specific website for this study that is accessible only to investigators using a password and username to login, which are provided after the accreditation of each participating center.
Data will be entered by each investigator directly through the web portal.
Once logged into the portal, the investigator is able to open a page where he can enter the required data of the patient by filling out a form and selecting the various features from dropdown lists made available for each parameter.
All of the features that have to be entered were previously standardized, and so data are selectable from the choices already made available.
The web portal was designed as each investigator has a personal protected page that is not accessible to other participants. So, the investigator can display real time entered patients’ data and manage their information. However, at the same time, the protection of data of each patient is guaranteed, and the data are editable only by the submitter.
In particular, the patient’s sensitive information are only recognized by the investigator of the center to which the specific subject belongs. Moreover, the system provides the use of a reference code for each patient who also appears in the general shared registry instead of the name.
Therefore, the adoption of advanced software technology in this study has made the complete management of the IMIGASTRIC registry in RDE (Remote Data Entry) mode, possible by exploiting broad band (ISDN, ADSL) Internet connection.
Any activity required by investigators can be performed through an application available online and accessible via a specific Internet address.
This solution allows for the centralization of information and activities directly within the Internet site devoted to this trial (documents, data, statistics, reports, alerts, etc.).
Through the activation of particular analysis tools, it is possible to obtain data in real time. Another unquestionable advantage is the assurance of data quality and safety. Within the platform there are programs designed to monitor the quality of data written in electronic formats. These electronic formats undergo a series of controls (logical and plausible), certifying their quality before being stored.
Data safety is ensured through a series of software (data mirroring, alerting systems, database architecture, etc.) and hardware (cartridge full backup, hot swap hard-disk with raid 5 system, etc.) high quality service devices.
Another advantage of this software is data access. There are various access profiles (user, administrator), each of which are authorized to display specific information for tailored management. This clinical trial management mode allows one to analyze any phase of the study and data in the database, due to an automated system the need to forward data is no longer required.
The method of approach used in the platform design phase is best characterized by having balanced the exigency to implement the application according to “Good Clinical Practice” and ensuring it is user friendly and safe.
The IMIGASTRIC software is an ERP (Enterprise Resource Planning) advanced system structured with specific sections dedicated to clinical data management and implementing processes for:
- Sites data and participant investigators’ data
- Integrated communication system
- Notice board for communications to be sent to all sites
- Documents useful and common to every centre
- The protocol of the study
- Data files (in electronic format)