ORGANIZATION

EURAP is organised in a network structure

Local centres constitute the first level of the network. Present in various European and non-European countries, they are represented by one or more Reporting physicians who play a key role in enrolling eligible patients.

Reporting physicians collect data using standardized Case Report Forms (CRFs) which are then transmitted through a web-based platform to the Central Registry in Milan, Italy.

The staff of the Central Registry checks the CRFs for either missing information or inconsistencies. Pregnancies reporting descriptions of congenital abnormalities are transmitted to the Outcome Assessment Committee for definitive classification of major malformations.

PATIENT ENROLLMENT

All women taking antiseizure medications at conception are eligible for inclusion whether the indication for treatment is epilepsy or other disorders. Recruitment is carried out by Reporting physicians after gathering two distinct informed consents from the enrolled patients, namely an informed consent for the participation to the study and another one for the data processing, as required by the EURAP core protocol.

To ensure anonymity, the patients’ personal data (date of birth or initials of their names) that may somehow lead to their identification are hidden in the Central Registry’s database and can only be seen by the Reporting physician collecting the data, in its local interface database.

To avoid selection bias, only pregnancies enrolled before foetal outcome is known and within week 16 of gestation can contribute to the prospective study. Retrospective cases are also collected as they may provide valuable information, but they are not included in the comparative risk evaluation.

REPORTING PHYSICIANS

Reporting physicians recruit eligible patients and collect their data inside the EURAP software using a standardized Case Report Form (CRF). The data collection methodology requires that pregnant women are visited regularly during their pregnancy, in order to collect the data prospectively. During the course of the pregnancy, and the follow-up time after delivery, the participating physician enters data into five subforms (A-B-C-D-E) for each patient.

Before starting the patient’s enrollment, physicians need to obtain approval from the Ethics Committee of their institutions, and they should always gather two different informed consents from each patient before registering their data.

NATIONAL COORDINATORS

National coordinators are officially appointed by the Central Project Commission (CPC) and are responsible for promoting and monitoring the progress of the Eurap study in their country, and thus establishing a regional network of Reporting physicians. To this purpose, they promote the protocol and may also distribute the study material among health care professionals. They assist physicians willing to join the project by providing them with the two mandatory patient’s informed consents translated in their local language, for a better awareness/understanding of the pregnant women.

National coordinators do also contribute to coordinate some activities with the CPC.

CENTRAL REGISTRY

The Central Registry is located at the Foundation IRCCS ‘Carlo Besta’ Neurological Institute in Milan, Italy. Activities carried out at the Central Registry do include:

  1. collection and management of data sent by National coordinators or Reporting Physicians: Case Report Forms are carefully checked by the central registry staff and resent to physicians when corrections or additional information are needed.
  2. online assistance and technical support to all EURAP collaborators.
  3. regular revision of procedures to improve data transmission and analysis.
  4. handling of pregnancies with descriptions of malformations to be submitted to the Outcome Assessment Committee.
  5. data auditing and periodical analysis to ensure accuracy and completeness and to provide statistics for semestral Interim Reports.