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Blog

Meeting the Challenges of Investigator-Initiated Trials

How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.

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6 min. read
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Blog

The Challenge of Unproven Regenerative Stem Cell Therapies

Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.

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7 min. read
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Blog

Six Key GDPR Questions to Review

Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?

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5 min. read
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Blog

Can Ethics Review Catch Up to the CBD Craze?

CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.

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4 min. read
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Blog

After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)

We have cancelled our webinar “After the Compliance Date: Revised Common Rule FAQs,” which was originally scheduled for February 28.

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Blog

Informed Consent Changes in the Revised Common Rule

If your research must comply with the revised Common Rule, you’ll need to update the way you write ICFs to meet the new requirements.

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Blog

Do I Need to Comply With the Revised Common Rule?

While many US researchers are aware of the coming Common Rule changes, not everyone is sure whether they will need to comply with the revised regulations.

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Blog

Reporting to the IRB: Serious Adverse Events (SAEs) in Drug Studies

Learn what the regulations say about IRB reporting requirements for serious adverse events and how undefined “gray areas” can be addressed.

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5 min. read
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Blog

ICH-GCP Guidelines and Research Conducted in the US

Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.

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3 min. read
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Blog

The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)

Please note that this material is provided for informational purposes only and not for the purpose of providing legal advice.

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7 min. read
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Blog

International Research and Research Ethics Review

Clinical research continues to grow throughout the world, with researchers looking outside the US for new and diverse subject populations to help develop and improve investigational therapies. Lauri Carlile, VP of Operations at Advarra, discusses the basics of ex-US research ethics review for US-based researchers.

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3 min. read
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Blog

Data Collection in Clinical Trials: 4 Steps for Creating an SOP

Learn the necessary steps to create an effective SOP for data collection in clinical trials when using an electronic data capture (EDC) system.

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6 min. read
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