CASE REPORT FORM (CRF): this is the standardized form approved by the Eurap study core protocol for registering the patients’ data. The CRF consists in five sub-forms (A-B-C-D-E) that should be filled in at regular intervals during patient’s pregnancy and up to 1 year after proband’s delivery. The Case Report Forms are available either on a paper version (.doc & .pdf), or, also on the electronic version that is accessible through the new web-based Eurap software that was released in September 2020 for an initial test phase.
CENTRE CODE: it is a code that identifies each local centre and consists in two digits that can be either numeric or alphanumeric. The Centre codes are usually assigned by the corresponding National Coordinators (where available), otherwise, the centre code can also be assigned by the Central Registry upon a National Coordinator’s request.
COUNTRY CODE: it is the number that identifies each country and consists in two characters, only numeric. Country codes are assigned exclusively by the Central Registry.
FIELD (white box): this is a dedicated white box in each sub-form, where you can provide the answer for any information requested. Most of the fields have some answers codes already listed inside the white box, among which the user may just select the appropriate information, while a few other fields with no answers codes are the so called “open fields” that should be used to report some additional information. Each sub-form A, B, C, D has at least thirty fields and all fields are numbered progressively from the top to the bottom of each sub-form. Sub-form E has eleven fields.
FORMS TO RECALL: these are pregnancies whose sub-forms (A,B,C,D or E) need to be updated, as their due time has expired. In fact, each sub-form (A,B,C,D,E) has a maximum time (or maximum due date) within which it should be completed, otherwise the record may loose its prospective status. Actually, for each sub-form the maximum due date is calculated at some pre-set intervals, all based on the date of last menstruation that is reported in sub-form A. Therefore, any Reporting Physician can periodically check the FORMS TO RECALL in his database by clicking on the dedicated button in order to retrieve the delayed sub-forms and provide the pending information within the sub-form’s final expiration date; this will avoid the record to be subsequently discarded by the Central Registry as “DROP-OUT”.
INTERIM REPORT: this is a periodic document that is released twice a year (May and November), and it contains some descriptive analyses that are extracted from the semestral auditing of the database.
PATIENT: this term refers exclusively to the pregnant woman, neither to the foetus nor to the baby in womb.
PREGNANCY IDENTIFICATION NUMBER (ID): It is the number that identifies each pregnancy. The IDs consist in 9 digits, namely from the left to the right there are 2 digits for the country code, 2 digits for the centre code and 5 digits for the pregnancy progressive number. NB: The ID number is progressive respect to the database of the recruiting centre.
PREGNANCY PROSPECTIVE: this term refers to pregnancies that are enrolled within week 16 of gestation and anyway before the foetal outcome is known.
PREGNANCY RETROSPECTIVE: this term refers to pregnancies that are enrolled after week 16 of gestation, or, pregnancies whose foetal outcome was already known at time of patient’s enrolment.
PREGNANCY RETRIEVED DROP-OUT: this term refers to those pregnancies that were initially registered as prospective because they were enrolled within week 16 of gestation and before the outcome was known, but, which were successively re-classified as retrospective cases because one or more sub-forms (A,B,C,D or E) were submitted after their pre-set deadlines.
PROBAND: this term refers to the foetus in womb, or, to the newborn baby.
RED LIGHT (or red dot): this term refers to any red bullet on the left side of each field, highlighting that such field needs to be checked by the Reporting Physician. The red lights (or red dots) are manually inserted (and removed) exclusively by the Central Registry and they contain a text message that clearly explains the correction requested.
STATUS of a sub-form: this is the label given to each sub-form (A,B,C,D, or E). The sub-form’ status is strictly related to its content and determines whether a sub-form does still have some pending information or not.
Status DROP-OUT: this status is given by the Central Registry to all those pregnancies that are lost to follow-up, either because the Reporting Physician could not reach the patient to complete the data registration, or, because the record has failed to be completed within its final due date.
Status INTERRUPTED: this status is assigned exclusively by the Central Registry to all those pregnancies that ended either with an abortion (regardless if spontaneous or induced), with a stillbirth, or, with a perinatal death. The status INTERRUPTED is inserted in all the sub-forms that are subsequent to the pregnancy trimester in which the abortion has occurred.
Some examples about STATUS INTERRUPTED: 1- if patient aborted during the first trimester of pregnancy, status interrupted will not be entered in the first trimester sub-form B, but only from the second trimester form to the end of the follow-up (thus on sub-forms C, D, & E). 2- if patient aborted during the second trimester of pregnancy, status interrupted will be entered only from the third trimester form to the end of the follow-up (thus on sub-forms D, & E). 3- if pregnancy is interrupted during the 3rd trimester of pregnancy, status interrupted will be entered only to the 1st year follow-up (sub-form E).
Status NOT-ELIGIBLE: this status is given by the Central Registry to all those pregnancies that do not meet the inclusion criteria according to the EURAP core protocol.
Status SENT OCC: this status is given by the Central Registry to all those pregnancies that report any proband’s anomaly to be classified by the Outcome Classification Commission (OCC). Hence, status “SENT OCC” just means that the record is in a kind of waiting status, as it has been sent to the OCC for a final assessment of the proband’s anomaly.
Status UNCLASSIFIABLE: this status is given by the Central Registry to all those pregnancies that could not be considered either as malformed or as normal even after their assessment by the Outcome Classification Commission (OCC).
YELLOW FIELD on the top of each record (YF): this is a yellow field that is located under each sub-form’s title and should be used by both the Reporting Physicians and the Central Registry in order to communicate each other. The yellow field refers to the whole record and not only to a sub-form, thus it can be accessed from any sub-form (A-B-C-D-E) simply by clicking inside such yellow box.
YELLOW LIGHT (or yellow dot): this term refers to any yellow bullet on the left side of each field, highlighting that such field needs to be checked by the reporting physician. The yellow lights (or yellow dots) are automatically inserted by the software when the sending procedure is launched, so that the Reporting Physicians can perform a preliminary check of their data before forwarding them to the Central Registry. Similarly to the red lights, the yellow dots contain a text message that explains the correction requested and are automatically removed by the system at the subsequent launch of the sending procedure, if the “mistake” has been fixed.