Clinical Trials

Lost in Translation – What does it mean to be a “Qualified Investigator”?

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 […]

Clinical Trials

“Lost in Translation” – Conducting Transnational Clinical Trials in Canada and the United States

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 […]

research ethics simplified
Case Study, en

Am I IRB Forum Shopping? Case Study #4 – IRB Forum Selling

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 […]

Case Study, en

Risk Management is not Negotiable! – Case #3 of “Am I IRB Forum Shopping?”

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 Inc.
Case Study, en

Am I IRB Forum Shopping? Case Study #2: Promotion Disguised as Research

  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. […]