Regulatory and Ethical Considerations for eConsent in Research
If any part of your informed consent process involves an electronic component, you’re conducting eConsent.
An Evolving Regulatory Environment for Rare and Orphan Diseases
By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.
Enhancing Research Conduct Using eConsent
The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.
5 Questions to Ask Your Sponsor for DCT Implementation
Sponsors are uncertain about how to design a DCT to ensure efficient performance delivery, learn how to set your organization up for success.
Clean Bench vs Biosafety Cabinet: What’s the Difference?
Using hoods with biological materials depends on directional airflow, and specialized airflow is necessary when handling hazardous materials.
Regulatory Considerations for Pharmaceutical Product Lifecycle Management
New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.
CBD Research: A Dive into the Regulations of Cannabis Research
With cannabis usage becoming more popular, there’s an uptick in research surrounding its therapeutic effects.
What is an sIRB and Why Does my Study Need One?
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB for trial oversight.
Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.
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
Return of Research Results to Study Participants
Research into participant experiences has consistently shown their desire to learn the results of research to which they’ve contributed.