109 Study protocol 3 To study the associations in the Identification group between potential determinants (genetics, pharmacokinetics and environmental factors) and the occurrence of dexamethasone-induced neurobehavioral problems a binary logistic regression model will be estimated. Odds ratios along with 95% confidence interval will be provided. Data, monitoring and publication All data is collected and stored in agreement with good clinical practice (GCP) guidelines. Certified members of the study team collect data on paper case report forms. OpenClinica Enterprise Version 3.13 is used to further collect and manage data. Blood is stored for 15 years. Deblinding takes place at the end of the study, after which the database will be frozen. All questionnaires are web based and data is collected through a secure website, www. hetklikt.nu, a safe internet environment, which is widely used in pediatric (oncology) care in the Netherlands.37 Adverse events are recorded, and all serious adverse events are reported to the competent authority by the investigator without undue delay, according to GCP. Patients can discontinue study participation at all times, without providing a reason for withdrawal. Standard insurance contracts apply in case of any unforeseen harm. Since patients are treated for a short time frame (2x 5 days) and the drug under investigation is well characterized and given in a physiological dose, we do not expect any suspected unsuspected serious adverse reactions.14 An independent certified third party (Julius Clinical) monitors the study. All processes including informed consent procedure, data collection and data management are monitored by this party. Monitoring takes place twice per year. The results of this study will be disclosed unreservedly in the form of scientific publications. Participants are notified of study proceedings through regular newsletters. When necessary the protocol can be modified or additions can be made. This can be done through amendments, which need approval by the Medical Ethical Committee.
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