Webinar

Regulatory Fine Points: Exploring 21 CFR Part 11 Validation

Upcoming: December 17

FDA is placing an increased emphasis on compliance with 21 CFR Part 11. Institutions, health systems, IRB offices, private research clinics, and developers—to name a few—need to understand the basics of the regulation and how to comply.

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Webinar

Institutional Responsibilities Under a Federalwide Assurance (FWA)

Upcoming: December 10

When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule.

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Webinar

Evaluating Payment to Participate in Research: Ethical and Regulatory Issues

In this webinar, Luke Gelinas, IRB Chairperson at Advarra, proposes a practical framework for evaluating offers of payment and applies it to case studies to yield guidance on challenging ethical and regulatory issues involved in paying research subjects.

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Blog

Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA)

Checking the box is still an option on the FWA. At this time, institutions must carefully consider whether it makes sense to check the box.

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Abstract

Ethical and Practical Concerns About IRB Restrictions on the Use of Research Data

Judith Carrithers, JD, Vice President of IRB Review, co-authored the article Ethical and Practical Concerns About IRB Restrictions on the Use of Research Data in Ethics & Human Research. 

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Blog

Is GDPR Coming to the US? CCPA and Its Impact on Research

New California regulations apply to companies who have information about CA residents regardless of where the company is located. Read more:

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Blog

Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements

Find out more about what to report to whom--and when--in the Q&A blog follow-up to our recent webinar. Read the answers to popular audience questions:

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Info Sheet

Advarra eReg Overview

The Advarra eRegulatory Management System (eReg) was developed through close collaboration with leading research institutions to help improve your regulatory process and enhance regulatory compliance across your organization.

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Info Sheet

Advarra EDC Implementation and Validation Services Overview

Leverage Advarra’s robust implementation and validation process.

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Blog

The Beginner’s Guide to an Electronic Data Capture (EDC) System

Electronic Data Capture system is software that stores patient data collected in clinical trials. Learn the basics and functionality of an EDC system.

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