2.12. Data collection and study ethics
Cancer
RECRUITMENT, -11, CROSS, CANCER
Data will be de-identified and recorded on electronic case report forms. Access to the electronic case report forms links will be restricted to the study investigators. If a subject withdraws from the study, reasons for the withdrawal will be recorded and all attempts will be made to collect endpoint data. Access to the participant’s personal information will be restricted to the study coordinator and investigators who are involved in the screening.This investigator-initiated clinical trial received funding support from National Research Foundation of Korea and Green Cross Corporation, but the sponsors are neither involved in the study design nor its proposed operations. The study will be conducted in full accordance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. The Korean Cancer Study Group Protocol Review Committee approved the study protocol (KCSG PC 22-11), and the approval of the Institutional Review Boards were obtained before the start of the patient recruitment at each institution (04-2022-021). Written informed consent will be obtained for all study participants by the principal investigator.