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Data-Management, Monitoring & Safety-Assessment

Data management

All study relevant data from all study sites will be entered and stored in an electronic Case Report Form (eCRF) of the secure online-database Secutrial® provided by the clinical trials center (CTC) of the university hospital of Zurich.

Randomization of patients into the respectitive treatment group will also be performed by Secutrial. Data entry in the eCRF will be performed by appointed investigators and study nurses. They will receive tele-training for data-input into the database with subsequent certification by the staff at the CTC in Zurich.

Data collection will be performed continuously, latest at time points listed in the study flow chart and the visit plan. Export of the data will be performed confidentially and, blinded for the Principle investigator, only after interim analysis and after closure of the study by the clinical trials center in Zurich.



Monitoring of the study site and study implementation in Zurich and the correct and complete input of Data of all centers into the eCRF will be performed by the clinical trials center (CTC) of the university of Zurich to ensure the progress of the clinical study, assure utmost accuracy of the data and to detect possible errors at an early time point. This is organized through the PI.

Collaboration centers should guarantee local onsite monitoring through their respective clinical trials center to ensure a correct course of the study at the respective hospital.

A template of a monitoring contract for the study can be provided by our center, but must of course be adapted to local laws and requirements.


Safety and Reporting of AE/SAE

During the entire duration of the study, all adverse events (AE) and serious adverse events (SAEs) that may be causally related to the study intervention are collected, fully investigated and documented in source documents. Reportable events are recorded in the electronic case report form (eCRF). Study duration encompassed the time from when the participant signs the informed consent until the end of the study specific follow up after 1 year.

All observed or volunteered adverse device events (serious or non-serious) and abnormal test findings, regardless of treatment group or suspected causal relationship to the investigational device or study treatment(s) will be recorded in the patient file and subsequently in the eCRF.  All AEs, serious and non-serious, will be fully documented in the appropriate eCRF. For each AE, the investigator will provide the onset, duration, intensity, treatment required, outcome and action taken.

All SAE have to be reported to the Sponsor-Investigator immediately within 24h.


Data safety monitoring Board

An international data safety & monitoring board (DSMB) with at least 3 independent experts (one hepatologist, one experienced HPB surgeon and a biostatistician; members to be appointed) will be installed to accurately monitor morbidity and mortality associated with the 2 interventions. They will receive summarized reports of all relevant AE/SAE and eventual mortalities after every 20 patients included. If morbidity and/or mortality for one or both arms exceed the expected mortality for Two Stage-Hepatectomy the board will take a decision and make a statement about early termination of the study for safety reasons. The chairman of the Data Safety Monitoring Board will report their decision to the Sponsor- Investigator in Zurich.


Interim analysis

An interim analysis is planned after inclusion of 100 patients. Data will be extracted from Secutrial® and interpreted by our study biostatistician in Zurich. Results will be sent to the DSMB for evaluation, which will then contact the PI and discuss the results and give advice on either continuing the study or for a premature stop for any relevant reason.

Results will afterwards be made available to all participating centers.


University Hospital Zurich
Department of Surgery
Raemistrasse 100
8091 Zurich, Switzerland


Phone: +41 (0)44 255 33 00
Fax:     +41 (0)44 255 44 49