Reporting adverse events
The (serious) adverse events can be reported in the eCRF program; www.castoredc.nl
When logged on to the study and patient go to ‘reports’. Click on the blue button ‘Add a report’, select the report form ‘Serious adverse event_ENG’ and click ‘create’. Please also notify the researchers through firstname.lastname@example.org or email@example.com .
Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the intervention. All adverse events reported spontaneously by the subject or observed by the investigator or his staff will be recorded.
A serious adverse event is any untoward medical occurrence or effect that
- results in death;
- is life threatening (at the time of the event);
- requires hospitalisation or prolongation of existing inpatients’ hospitalisation; except hospitalization for labour, diagnostic laparoscopy, vacuum curettage in case of an incomplete miscarriage or ovarian hyper stimulation syndrome (OHSS) during IVF.
- results in persistent or significant disability or incapacity;
- is a congenital anomaly or birth defect; or
- any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgement by the investigator.
An elective hospital admission will not be considered as a serious adverse event.