Strategic responsibilities

• The clinical research physician is assigned to one or more EORTC disease oriented groups.
• The clinical research physician is the therapeutic area expert and liaison within the EORTC headquarter. He/she is responsible for reviewing presentations and reports for the group meetings from the medical standpoint, and for helping with strategy and publications.
• The clinical research physicians is responsible for leading the groups through the process of taking concepts and proposal through EORTC approval processes up to rejection or approved protocol outline and is accountable for following up to conclusion with the involved parties.

Responsibilities in protocol development and trial conduct

The clinical research physician is supervising the trial conduct from the medical standpoint. He/ she can be helped in that task but more junior physician or other headquarter staff. In that case the research physician will have the responsibility to train and supervise the person to whom those tasks are delegated

• Is responsible for the protocol development. The CRP is the main contact of the EORTC Protocol Help Desk to initiate, coordinate and release the protocol outline and the full protocol document. The CRP is therefore responsible for the final content of the protocol at the end of the protocol development process and should identify and resolve potential discrepancies between inputs from the different functions.
• Ensures the correct clinical understanding of the protocol by all study participants, on clinical site, at the headquarter, or by members of other participating organizations (companies, CROS.).
• Helps the study team identifying the clinically critical parameters to be checked, queried and controlled, and provides medical input for the statistical design
• Is responsible for medical monitoring of EORTC sponsored study, which includes but is not limited to, ongoing patient eligibility, protocol compliance, periodic safety reviews, safety monitoring, final patients review, and works closely with the study coordinator on all medical matters. In the cases where a third party is involved in those activities (i.e. industry or another group), the CRP is the central contact person at EORTC for all medical matters.
• Supports the statistician in preparing the IDMC
• Agrees with the study coordinator at the beginning of the study on a process for individual patient reviews.
• Is part of the reporting team and provides medical input for the data management and statistics leading to reporting.
• Is responsible for the medical interpretation of the study report and is part of the publication team when the study leads to publication.