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White Paper

Unique First-in-Human Phase I IRB Considerations you Might not Know About

An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.

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Blog

Developing and Implementing a Successful eConsent Process

As the industry continues to shift from brick-and-mortar trials to more convenient hybrid formats, eConsent proves to be useful.

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Blog

Why Now is the Right Time to Adopt eConsent

A valuable tool for both sites and participants, now is the right time for sites to adopt an eConsent platform.

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Webinar

How to Optimize Your sIRB Experience

Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.

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Blog

Why Keep HIPAA Separate from the Informed Consent Form

HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.

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Blog

FDA’s September 2022 NPRMs: What They Mean for Academia and Industry

FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.

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Blog

Informed Consent Writing Tip Sheet

Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it. 

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8 min. read
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Blog

Regulatory and Ethical Considerations for eConsent in Research

If any part of your informed consent process involves an electronic component, you’re conducting eConsent.

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Blog

Enhancing Research Conduct Using eConsent

The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.

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Blog

Short Form Consents and the Unexpected Non-English Speaking Participant

What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?

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3 min. read
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Blog

Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents

Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools

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5 min. read
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Podcast

Becoming Your Own Best Advocate Through Patient Empowerment

In this episode, we discuss clinical trial patient empowerment and advocacy. We dive into health literacy and the informed consent process.

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