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 a standardised Case Report Form (CRF) and send it immediately to their own National coordinators for a preliminary check.

CRFs are subsequently transferred to the Central Registry in Milan, Italy, where they are further controlled for missing information and inconsistencies. Pregnancies reporting descriptions of congenital abnormalities are transmitted to the Outcome Assessment Committee for definitive classification of major malformations.

PATIENT ENROLMENT

All women taking antiepileptic drugs at conception are eligible for inclusion whether the indication for treatment is epilepsy or other disorders. Recruitment is carried out by Reporting physicians after obtaining informed consent as required by the Ethics Committee of the individual country.

To ensure anonymity, each case is identified with only the date of birth of the mother and the first three letters of her surname. To avoid selection bias, only pregnancies enrolled before foetal outcome is known and within week 16 of gestation contribute to the prospective study. Retrospective cases are also collected as they may provide valuable information but are not included in the comparative risk evaluation.

REPORTING PHYSICIANS

Reporting physicians recruit eligible patients and report them immediately to their own National coordinators. This is done by filling in and transmitting the first sub-form of the Case Report Form. If no National coordinator is available, cases are directly reported to the Central Registry. Their task is also to assess each case every trimester of pregnancy and when the baby is 1 year old. This is carried out either by visit or phone interview and entails careful compilation of the corresponding sub-forms. Physicians who cannot follow up their patients personally, can refer them to any clinical centre identified by their National coordinator.

Several Reporting physicians may refer to a single local centre. Each local centre receives an identification centre code from the National coordinator. Before starting to collaborate, centres need to obtain approval from the Ethics Committee of their institutions.

NATIONAL COORDINATORS

In each country there is a National coordinator who is officially appointed by the Central Project Commission (CPC). Some countries may have regional coordinators representing more than one nations.

National coordinators are responsible for initiating and monitoring the study in their regions and thus establishing a regional network of Reporting physicians. To this purpose, they promote the protocol and distribute study material among health care professionals. They take care of physicians willing to join the project by providing all the necessary information and assistance. They build national databases and play an active role in checking CRFs sent by Local centres before forwarding them to the Central Registry in Milan. National coordinators also contribute to coordinate activities with the CPC.

CENTRAL REGISTRY

The Central Registry is the site of EURAP database. It is located at the Foundation IRCCS ‘Carlo Besta’ Neurological Institute in Milan, Italy.

Activities carried out at the Central Registry include:

  1. collection and management of data sent by National coordinators: Case Report Forms are carefully checked and resent to physicians when corrections and additional information are needed
  2. supervision of activities within the EURAP network to ensure the strongest concordance between national databases and the Central Registry
  3. online assistance and technical support for all EURAP collaborators
  4. regular revision of procedures to improve data transmission and analysis
  5. handling of pregnancies with descriptions of malformations to be submitted to the Outcome Assessment Committee
  6. periodical analysis of data and auditing to ensure accuracy and completeness and provide statistics for half-yearly Interim Reports