Table 3 Key issues to be considered for organisation of Clinical trial Centres (CTC) and Clinical Sites (CS).

Study selection

• Evaluation and decision making by transparent process according to FINER-Criteria [11]

F Feasible

I Interesting

N Novel

E Ethical

R Relevant

• Funding sources avaliable

• How many eligible patients can I get? (approx. 10 patients per year and trial are recommended)

• Does the case money cover all costs?

• Are the proposed interventions feasible at the institution?

• Can patients be followed up according to the protocol?

Study conduction

• Adequate recruiting of CS (prior trial experience, sufficient patient populations)

• Continuous supervision of Clinical Sites performance (e.g. monitoring, auditing)

• Meetings prior to start of patient recruitment

• Training of participating surgeons in methods of clinical Trials

• Standardized enrollment process (i.e. screening of all admitted patients, informed consent, randomisation)

• Adherence to the study interventionsl and the national and international guidelines (e.g. GCP, Declaration of Helsinki)

• Organization of follow up and documentation

• Controlling of recruitment, treatment, and financial procedures

Networks and Partners

• Scientific societies

• Governmental authorities (e.g. FDA)

• National and international experts in trial methodology and the individual speciality

• Funding organisations

• Ethics committee

• Administration (contracts)

• Departments collaborating in treatment of patients (e.g. anaesthesiology, radiology)

• Institutions involved in required tests or delivery of study materials (e.g. laboratory, pharmacy)

• IT Infrastructure

Required human resources

• Principal Investigator

• Project manager

• Biostatistician

• Data manager

• Monitor

• Quality Assurance agent

• IT Manager

• Administrative agent

• Study physician

• Study nurse