Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Important protocol amendments will be listed on the ClinicalTrials.gov webpage for each trial and be made available via the BlueSky training portal, clinical trial managers and the BI clinical trial portal Clinergize. Any deviations from the protocol will be fully documented. The principal investigator is responsible for IEC/IRB submissions according to local regulations.