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Case Study, Clinical Trials, Crisis Management, Guidelines & Regulations, Informed Consent, Research Participants

A Tribute to Ellen Roche

In recognition of World Asthma Day, we wish to underline the importance of pursuing clinical research in order to improve the quality of life for the 300 million people affected by this disease. It is also important to remember those, like Ellen Roche, who participated in such clinical research. Ellen Roche was an employee at […]

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Clinical Trials, Guidelines & Regulations, Informed Consent

The Revised Common Rule:
Trans-border Research and Henrietta Lacks

It is refreshing to see policy changes influenced by the evolution of science as opposed to crisis. The increased engagement of research participants in research coupled with increasing complexities in the research landscape have catalyzed revisions to the Common Rule. Inspired by the Belmont Report, the Common Rule was developed to ensure that research involving […]

Am I IRB Forum Shopping - Introduction
en, Guidelines & Regulations

Am I IRB Forum Shopping? – Introduction

We recently revisited the Montreal tuberculosis outbreak wherein we identified IRB Forum Shopping as the root cause of this tragedy. IRB Forum Shopping is an under-researched yet highly-relevant ethical issue in the context of the North American governance of clinical research. Essentially, it is the practice of choosing an IRB based on the relative ease […]

en, Guidelines & Regulations

Will Health Canada still acknowledge clinical trial notifications?

On July 30, 2014, Health Canada announced that the Office of Clinical Trials of the Therapeutic Products Directorate (TPD) will cease issuance of ‘Acknowledgement of Notification’ letters for Clinical Trial Application Notifications (CTA-Ns) on September 1, 2014. What does this mean for your clinical trial? First off, this change applies only to clinical trials involving […]

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en, Guidelines & Regulations

How to obtain a Health Canada Research Ethics Board Attestation (REBA)

When conducting clinical trials in Canada, a Sponsor must generally possess, for each clinical trial site, a Research Ethics Board Attestation (REBA), which provides administrative information regarding the research ethics board (REB) as well as a certification that its composition, operations and decisions are in compliance with Canadian regulations. A REBA must also be completed […]

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en, Guidelines & Regulations

What’s the difference between Canada and US: CTA versus IND?

If you are a Sponsor/CRO conducting clinical research in both Canada and the U.S., there are important differences between the Canadian Clinical Trial Application (CTA) and the U.S. Investigational New Drug (IND) submission process. IND Submission Process in the U.S. In the U.S., once the IND has been submitted for review, the FDA has 30 […]