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Compliance In Focus

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Keep Your Clinical Trial Moving from a Distance

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.

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Posted by Melissa Wollerman on Thu, Dec 05, 2019

Revisions to the Common Rule; Part II

In a previous blog post, revisions to the Common Rule were to be implemented January 19, 2018; however, due to a Notice of Proposed Rulemaking (NPRM), the compliance date was delayed until January 21, 2019.

Topics: History of Clinical Research, The Common Rule

Posted by Carla Glass on Tue, Feb 07, 2017

Revisions to the Common Rule

U.S. federal regulations governing the protection of human subjects in research have been in existence for more than 30 years. The Department of Health, Education, and Welfare first published regulations for the protection of human subjects in 1974, and the Department of Health and Human Services (HHS) revised them in the early 1980s. To promote uniformity, understanding, and compliance with human subject protections, U.S. federal departments and agencies adopted the revised version of the regulations in 1991; subpart A of 45 Code of Federal Regulations (CFR) part 46 was created. This is often referred to as the “Common Rule” or “Protection of Human Subjects Regulations”.

Topics: The Common Rule, U.S. Federal Regulations, Revisions

Posted by Shawn Kennedy on Thu, Sep 24, 2015

The Common Rule (1991)

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar years.

Topics: History of Clinical Research Timeline, IMARC Research, The Common Rule