Applied Clinical Trials
Apart from training and certifying individual EC members, the Dutch Central Committee on Research involving Human Subjects (CCMO) recently added training of investigators to its repertoire.
Apart from training and certifying individual EC members, the Dutch Central Committee on Research involving Human Subjects (CCMO) recently added training of investigators to its repertoire.
On December 3, 2012, at the Academic Medical Center Amsterdam, Prof. dr. Marcel Levi opened the eLearning website Onderzoekswijs.nl. "Clinical Research in our country is still standing strong, as compared to other EU countries. The number of trials taking place in the Netherlands this year is even a bit higher as compared to last year," Levi said. Of all trials performed in the Netherlands, more than 40% are categorized as "investigator-initiated," a number which has remained quite stable over the last few years.
The free-to-use modules, that were designed on the basis of frequently asked questions from the field, offer no examination. However, after the instructions, a user may test his/her knowledge gained by answering a few questions, with direct feedback. Currently six themes are covered:
Four of the six start off with a video fragment. More modules may be added. In principle, the eLearning is intended for those interested/involved in investigator-initiated trials. However, any investigator may benefit from its contents.
CCMO anticipates the eLearning modules will soon be used in the compulsory training by all eight Dutch University Medical Centers.
The website's slogan is "Test and Increase Your Knowledge" with the language used in the eLearning modules being Dutch. Further information can be obtained from ccmo@ccmo.nl.
—Edgar Smeets
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.