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Blog

Differentiating “Public” and “Private” Internet Spaces in IRB Review

The difference between “public” and “private” internet spaces has gained importance with the growing research use of internet and social media platforms as data sources. Read more:

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Blog

Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues

Dr. Gelinas answers audience questions we weren’t able to address during the webinar.

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6 min. read
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Blog

Study Activation: A Complex Process That Doesn’t Have to Be Painful

If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.

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3 min. read
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Blog

IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider

Advarra IRB experts discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review. Read more:

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5 min. read
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Case Study

Part 11/Annex 11 Independent Audit and Compliance Assessment

Learn how the Advarra Consulting team deployed a proprietary Part 11 / Annex 11 assessment and mock inspection program.

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White Paper

Special Considerations for Pediatric Trials

In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.

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Blog

Revised Common Rule Compliance Now in Full Effect—and What That Means

The Revised Common Rule is here after multiple delays, exceptions, and many training sessions. As of January 20, 2020, this regulation is in full effect.

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3 min. read
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Blog

Beyond the Regulations: More Considerations for Emergency Research

Go beyond the regulatory requirements and examine three key actions research organizations must consider before conducting planned emergency research.

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7 min. read
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Blog

Reporting to the IRB: What NOT to Report

Reportable events can be tricky: according to the regulations, not every unanticipated event should be submitted to the IRB.

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6 min. read
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Blog

Making Sense of the New HUD Guidance

Understand how the new HUD guidance clarifies responsibilites of the IRB and institutions, while widening the access of small communities to HUDs.

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7 min. read
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Blog

Should Social Media Be Part of Your Research Toolbox?

Social media has emerged as a valuable tool for diverse stakeholders across the research community. Learn about the risks and benefits in this article.

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5 min. read
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Blog

Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies

What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.

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2 min. read
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