James Riddle

by James Riddle

The Top Five Articles of 2018

As we prepare for 2019 in earnest with Common Rule implementation, new FDA harmonization activity, fallout from GDPR, and a host of other issues important to moving research forward, we should also take a moment to reflect on the previous year, and be mindful of how the developments of 2018 will shape our world into 2019 and beyond. Below are the most-read, most-popular articles, covering many key events from last year:

1. Calling All McFlys: A Checklist for Going Back to the Future on the Revised Common Rule

In late February, as the Common Rule was delayed, we went “back to the future” with Aarthi Iyer, to more closely examine the proposed changes. The updates included tightening local policies, adding National Institute of Health (NIH) policies for issuing Certificates of Confidentiality, and addressing the 21st Century Cures Act. Flux capacitor not included.

2. The IRB’s Role in Reviewing GDPR Consent Language

The implementation of the European Union’s General Data Protection Regulation (GDPR) has demonstrated global implications for the use of digital technology. Even in the United States, GDPR must be considered for research conducted abroad. Learn more about how IRBs are expected to engage with GDPR with Michelle Francis Grienauer’s in-depth summary of the issue.

3. These Are the Droids We Were Looking For: FDA Adopts the E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)

The E6 (R2), although perhaps sounding more like a robot than a regulation, was an important step toward adapting the International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines to reflect current methods of clinical trial design, while fostering an alliance of good clinical practices on a global scale.

4. Survey Results: Top 5 Regulatory Challenges

Regulatory change has always and will always be ongoing, but in recent years the speed of change has increased in response to the equally increasing speed of innovation across the research community. Discover the top regulatory challenges researchers faced this year, as reported by attendees of our webinar, “How Legal and Regulatory Changes Impact Your Research.”

5. All I Want for New Year’s is FDA IVD Guidance

For over a year, the FDA had been working on additional guidance for in vitro diagnostic devices (IVD), and finally in January of 2018, released new guidelines. These include definitions and concepts that are important in assessing investigational IVD risks, roles and responsibilities of sponsors and IRBs in complying with investigational device exemption (IDE) requirements, and the FDA’s recommendations and requirements for submitting significant risk investigational IVD IDE applications.

James Riddle

Executive Insight

James Riddle, MCSE, CIP, CPIA, CRQM, Executive Vice President of Kinetiq

Your continued readership speaks volumes on the importance of addressing regulatory guidance and reinforces why Kinetiq is dedicated to providing engaging and useful information to the research community. All top-five most-read articles from 2018 were focused on different regulatory changes that impact research and technology applications to research, including—ironically—a top-five regulatory challenges article based on survey data from a webinar on regulatory changes. The team at Kinetiq will continue to provide helpful advice in 2019 to move your research forward.

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