IAOCR, a leading provider of independently recognized, competence-based accreditation, consultancy and accredited training for clinical research professionals, welcomes the new EU regulation on clinical trials of medicinal products for human use as an important step for the safe implementation of clinical trials. The new regulation is designed to provide a more streamlined approach to the conduct of trials with greater public openness about each trial and the results they produce. The implementation date is planned for the 28th May 2016.
“IAOCR is delighted the EU has addressed the clear need for better regulation of clinical trials, however there is still a long way to go,” commented Martin Robinson PhD, Executive VP & IAOCR Ambassador. “These changes will work towards ensuring patient safety is at the forefront of clinical trials but the competence of those undertaking the trials is also required to ensure a robust, proficient and safe system is in place across Europe. IAOCR is committed to ensuring clinical researchers are qualified by education, training and experience and believes accreditation helps to ensure that Good Clinical Practice (GCP) is adhered to and that patients’ rights and wellbeing are upheld.”
The new regulation was approved by the European Parliament in April last year and has now been published in the official Journal of the European Union. It replaces directive 2001/20/EC – the Clinical Trial Directive which has been in place for almost a decade. The benefits associated with the new regulation include a single approval portal, standardized content of clinical trial applications, information about subject protection and informed consent, more stringent requirements for reporting trial progress and greater transparency about clinical trials.
The regulation will be applied in full in all member states, with no need for separate national legislation and this will result in consistent and uniform application throughout EU allowing the EU Commission to conduct controls in Member States making sure that rules are properly supervised and enforced.
IAOCR’s Qualified Clinical Research Trainers have delivered training programs to over 250 clinical research organizations spanning five continents. They have practical working experience in clinical research and have passed comprehensive competence assessments.