Monitoring and data management
toxicity, ICH, ®, Cancer
CANCER
The study will be risk based monitored according to International council on good clinical practice (ICH GCP) by an independent Clinical Research Monitor, including source data verification. Although toxicity is expected to be low, this phase I protocol will be considered as a high-risk study.Central data management will be performed at the Data Center of the Netherlands Cancer Institute. All collected patient data in this trial will be coded and used in a pseudonymized manner. Registration will be performed using the ALEA® (FormsVision BV) registration package (FormsVision BV). All data that is relevant for the study will be collected using electronic Case Report Forms (eCRFs) in ALEA. Checks are incorporated into the eCRF system and data from all patients is centrally checked at the Data Center. When persistent irregularities or protocol violations are detected, the Data Center will inform the local investigator (and Principal Investigators) and queries will be sent to the local Data Manager. The completed eCRFs will be reviewed, signed and dated by the principal investigator or sub‐investigator.In accordance with the Dutch regulations, the investigator will retain all pertinent information for a period of 25 years from study completion. Trial data is only accessible to the study physician, principal investigator and external data monitor. The handling of personal data will comply with the General Data Protection Regulation (GDPR) (in Dutch: AVG, Algemene Verordening Gegevensbescherming).