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 common clinical terms are understood in both countries.

Examples of common expressions having different meanings in both countries are numerous. For example:

  • Did you know that an investigator does not need to be a licensed physician or dentist to conduct a drug clinical trial in the United States while it is mandatory in Canada?

  • Did you know that while the FDA has a documented preference for placebo-controlled trials, Canadian normative documents tend to promote the conduct of active-controlled trials?

  • Were you aware that in Canada, unlike the United States, you cannot implement a study protocol amendment without first obtaining a formal regulatory authorization?

At the SoCRA conference we will explore how concepts like “qualified investigator”, “randomized controlled trial”, “compensation for injury”, “regulatory approval” and “safety reporting” can impact your study depending on which side of the border you conduct your study.

Ignoring these differences can negatively impact your study and may lead to confusion, delays and potential findings of non-compliance.

There are over a dozen similar examples that illustrate the differences in conducting transnational research in Canada and the United States. We will cover these topics as part of an upcoming blog series.

Find out how your study could benefit from our experts’ in-depth knowledge of local requirements.

 

About the Author

Martin Letendre

Martin Letendre is responsible for managing Veritas IRB's business operations and administering the activities of the Veritas IRB Boards. Martin is a member of the Quebec Bar and brings more than a decade of experience in health law and research ethics. His expert knowledge of, and ongoing activity and interest in research ethics have led to the publication of several reports and articles in peer-reviewed journals, and invitations as guest speaker at numerous conferences and scientific meetings. Martin was actively involved in the creation of an on-line tutorial for institutional research ethics boards in Quebec and was a member of Canada's three federal research agencies' Panel on Responsible Conduct of Research.
The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.

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