Informed Consent
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.
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.
Informed Consent Writing Tip Sheet
Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it.
Regulatory and Ethical Considerations for eConsent in Research
If any part of your informed consent process involves an electronic component, you’re conducting eConsent.
Enhancing Research Conduct Using eConsent
The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.
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?
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
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.
Large Clinical Research Site Network Streamlines Study Startup with Reliable, Timely ICF Writing Services
Advarra improved startup timelines by writing compliant informed consent forms (ICFs) for a large clinical research site network.
What do I do About Incidental Findings in Research?
Each incidental finding has an impact on how research professionals handle the result and whether it should be shared with participants.
eClinical Regulatory Trends Impacting Clinical Research
Understand current regulatory trends in clinical research and how it will shape the industry moving forward.
Advarra Research-Ready Training Services
Advarra’s Research-Ready Training applies effective and innovative eLearning techniques for required research topics.
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