Stephanie Pyle

Director, Content and Communications, Advarra

Latest Posts by Stephanie Pyle

Integration Update: Leading Compliance Adherence

The Advarra team is proud to announce that all major integration activities are now complete....

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FDA Guidance Addresses Impact of Revised Common Rule on FDA-Regulated Clinical Trials

FDA releases guidance on the impact of the revised Common Rule on FDA-regulated research to...

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Updated IRB Policy on Blood Volumes in Research

Advarra has updated its IRB policy for documenting total blood volume in research. The study...

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Updated IRB Policies for Research Involving Minors

Advarra has updated its IRB policies for research involving minors. This includes policies on obtaining...

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Updated IRB Policy on ICH-GCP Compliance for Research Conducted in the US

Advarra has updated its IRB policy on applying ICH-GCP Guidelines to US research. The IRB...

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Proposed Changes Released for Review of Gene Therapy Research

NIH has published a proposal to amend the NIH Guidelines to streamline oversight for human...

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Advarra’s Approach to Common Rule Revisions

Advarra will implement the Common Rule revisions, including the 3 burden-reducing provisions, on the new...

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20th Annual Human Subject Protection Conference

Join us Thursday, October 4, for our annual conference Human Subject Protection: Roll With It....

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Compliance Date for Common Rule Revisions Delayed an Additional 6 Months

US federal departments and agencies have published a final rule delaying the revised Common Rule...

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Holiday Meeting Schedule – Memorial Day

Due to the upcoming Memorial Day holiday, some review timelines and IRB/IBC meeting dates have...

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GDPR Data Protection Regulation Effective May 25, 2018

The EU's General Data Protection Regulation (GDPR) goes into effect May 25, 2018. While the...

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

The European Union’s General Data Protection Regulation (GDPR) goes into effect May 25, 2018, replacing...

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