Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
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.
Institutional Responsibilities Under a Federalwide Assurance (FWA)
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.
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.
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.
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.
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:
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:
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.
Advarra EDC Implementation and Validation Services Overview
Leverage Advarra’s robust implementation and validation process.
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.