DATA COLLECTION

 

Information will be collected and recorded by all institutes through a specific online shared system.

To facilitate and standardize data collection, speed up the creation of a shared database and ensure the security of sensitive data, a special online computerized web system has been developed.

The creation of a multi-institutional registry involves many obstacles. So, the following critical issues were considered.

As the investigators belong to centers located in different parts of the world, there is a high risk of generating transmission errors during the different stages of collection and submission of data.

In addition, each investigator may have difficulties in managing entered cases during different study steps, which could induce investigators to leave the study.

For these reasons, the intent was to make the entering and the sharing of data as easy as possible to increase the chances of success of the registry in the retrospective sense.

Therefore, a system of online submission and sharing of patient’s data through a dedicated and protected website was planned.

The organizing committee of the registry with the cooperation of specialists in software programming, created a website that is accessible only to investigators using a password and username to login, which are provided after the accreditation of each participating center.

Data are not sent via email or spreadsheets but 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 simply filling out a form and selecting the various features from dropdown lists made ​​available for each parameter.

In fact, to facilitate the submission of information and their subsequent analysis, all of the features that have to be entered were previously standardized, and so data are selectable from the choices already made ​​available, without the need to write or specify anything else.

Investigators have to provide the required data as completely as possible; however, the absence of certain information does not preclude sending the remaining data.

In fact, if some parameters are not recorded in patient files or are not provided because of an institute’s policy, the investigator can send only the data of the variables at his disposal.

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.

In this manner, it is hypothesized that the maximum chance of accuracy in the collection and maintenance of data can be achieved.

Therefore, each investigator has a two-function tool accessible via the web. The first provided function is a personal web page through which he can manage the data belonging to his institution, and the second function is the access to a shared web page on which there are data of all patients of the multi-institutional registry.