Study monitoring
RECRUITMENT
Study monitoring is done by the Heidelberg Clinical Studies Coordination Center (KKS). The first monitoring visit at each study center is scheduled to occur at the end of the second patient’s induction therapy. Further monitoring visits at each study site will depend on the (i) recruitment success of study participants, (ii) the monitor’s assessment of the trial site’s compliance with applicable stipulations (e.g., number and severity of protocol deviations or deficiencies detected during study visits), (iii) the deficiencies detected via Central Data Review, and (iv) the assessment of the coordinating team. The monitoring is carried out according to a monitoring manual giving comprehensive guidance on monitoring activities (Source Data Verification rules, corrective and preventive actions, documentation of protocol violations, escalation of findings, etc.).