Author: Fraser

A Critical Look at Inclusion & Exclusion Criteria

A Critical Look at Inclusion & Exclusion Criteria

Based upon US FDA Workshop Report April 16 2018 In response to the FDARA( Food and Drug Reauthorization Act) of 2017, the US FDA recently convened a workshop to evaluate inclusion & exclusion criteria in clinical trials. This workshop was attended by...

FDA Common Rule- A Much Needed Update

FDA Common Rule- A Much Needed Update

In a sweeping gesture to better protect human research subjects, sixteen US federal agencies issued a revised Common Rule on January 19, 2017, the first update since 1991.  The final rule, officially known as Federal Policy for the Protection of Human Subjects, aims...

FDA Releases GCP E6 R2 Guidance

FDA Releases GCP E6 R2 Guidance

Released by the International Council on Harmonisation (ICH) in November 2016, Good Clinical Practice’s second revision, R2 has been making waves in the clinical research industry. In March 2018, the US FDA released E6(R2) Good Clinical Practice: Integrated Addendum...

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