WHAT DOES THE EU REGULATION 536/2014 HAS TO DO WITH MY STUDY SITE?
A new EU regulation (536/2014) will inure on the 01.02.2022, regulating quality standards of clinical trials! There is need for action!
A session was held online to explain all sites which requirements are needed. We explained purposes, scopes and consequences of the new EU regulation.
WHAT ARE CONSEQUENCES?
These changes are comprehensive. Higher safety standards will become mandatory which will lead to more streamlined procedures for clinical trials. Despite increasing requirements, the regulation also brings advantages such as an almost complete, Europe-wide harmonization of approval procedures and uniform assessments for all member states. This should lead to less administrative work. In addition, transparency will be increased, as the EU portal will be publicly accessible to everyone soon. However, some more complex procedures will affect study sites such as higher documentation effort , high level personnel, time capacities and professional competence.
HOW DO WE SUPPORT?
We are able to support study sites with the implementation, training and quality checks of standard-compliant processes in the fields of quality management and standard operating procedures (SOPs). In addition, we provide standardized documents (worksheets, checklists, etc.) and monitor the digitalization of study sites by implementing the respective software.