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Trials in the United States are changing - Federal regulations series part 1 of 5

Regulations governing clinical trials in the US have remained unaltered for several decades. This is due to change in the near future as the Common Rule of HHS Regulation (45 CFR 46, Subpart A) is being significantly updated.

The proposed changes to the Common Rule and subsequent harmonisation of FDA Regulations will impact research organisations, sponsors and clinical trial investigators alike.

This article is the first in a series of five, reviewing the rationale and expected impact of proposed reforms. In this first article, we provide an overview of the proposed changes, why they’re being reviewed and when the changes will come into play.

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