Based on Canadian and American regulations and guidelines, research sponsors and IRB/REBs must assess the qualifications of the investigator to conduct and supervise the proposed clinical trial. Steps may include, but are not limited to, the evaluation of the investigator’s resume, reviewing relevant publications, and assessing whether they have received the proper training on the […]
This weekend, the Society of Clinical Research Associates (SoCRA) will host its 25th annual conference in Montreal, Quebec. As part of the conference, Veritas IRB will be reflecting on the experiences and challenges researchers face when conducting clinical trials across borders. Very often researchers experience confusion, and even frustration, arising from the misinterpretation over how […]
Over the past month, we have written five posts in the series “Am I IRB Forum Shopping?”. Our first post was an Introduction to IRB Forum Shopping; the unethical practice of choosing an IRB based on the relative ease of the review and the perception that the review will result in a favourable decision. We presented […]
The Montreal Tuberculosis Outbreak remains the most blatant case of IRB Forum Shopping in history. The events can be summarized as follows: The Montreal Tuberculosis Outbreak remains the most blatant case of IRB Forum Shopping in history. Why did SFBC Anapharm send their fourth study to IRB Services? Could it be that SFBC Anapharm had […]
In December 2015, a Canadian research sponsor submitted a Phase III, multicenter study to Veritas IRB for review. It involved women, 45 years of age and over. Veritas IRB approved the study with the condition that women of child-bearing potential must undergo routine urine pregnancy testing during their participation in the study and upon exiting […]
Veritas IRB has received three submissions in the past five months of post-marketing observational trials from two research sponsors (the Canadian office of one of the top 20 pharmaceutical companies, and a Canadian-based pharmaceutical company). All three trials had one thing in common; they were old-fashioned seeding trials disguised as bona fide research studies. […]
