In clinical research, the International Council for Harmonisation (ICH) defines SOPs as “detailed, written instructions to achieve uniformity of the performance of a specific function”.
SOPs at EAU RF is applied for related clinical studies. There the focus is always set on repeated application of unchanged processes and procedures and its documentation, hence supporting the segregation of origins, causes and effects. The study director is mainly responsible for SOPs. The Quality Assurance Unit consist of individuals who are responsible for monitoring whether the study report and tests are meeting the SOP. Herewith we present our EAU RF SOPs for setting up a Registry and for the collection of blood, urine and specimen.
Please find below a list of currently available SOPs
Medical societies and patient advocates across disciplines call for urgent action to make clinical trials less bureaucratic and more patient-centered, efficient and cheaper.
Excessive administrative demands lead to rising costs and complexity, stagnation of clinical research in Europe, fewer academic clinical trials and limited access to innovative treatments. Unnecessary, inefficient, overly complex or ambiguously worded regulations, guidelines, safety reporting requirements and informed consent procedures pose a threat to exactly that which they were designed to protect: the quality of clinical trials and the safety of patients.
That more flexible, risk-based and pragmatic regulation is possible, without compromising either quality or safety, was demonstrated by the guidance issued by European regulators on the management of clinical trials during the Covid-19 pandemic. A substantial and structural reduction of bureaucracy in clinical trials must be the shared goal of clinical researchers, patient advocates, policymakers and regulators at EU and national levels, ethics committees and the pharmaceutical industry.
At stake is the efficiency and affordability of clinical trials, and with it the quality of future health care and – ultimately and most importantly – patient safety.
See the coalitions statement here
Since the EAU Foundation for Urological Research is settled in the Netherlands, the “Wet Normering Topinkomens” is taken into account for the remuneration of the Board.
The remuneration of the Board has been fixed by the General Assembly of the European Association of Urology at €15,000 per year for the Chairman. Other members of the Board received no remuneration.
Download the annual report 2020 here.