Institutions
Beginner’s Guide to 21 CFR Part 11 Compliance
FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.
Safe Sharps Handling When Dispensing Investigational Products
Care must be taken to avoid sharps-related injuries and exposures when preparing investigational products for clinic transportation.
Regulatory and Ethical Considerations for eConsent in Research
If any part of your informed consent process involves an electronic component, you’re conducting eConsent.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Insights into the site selection process and the information sites provide as part of site feasibility questionnaire completion.
Enhancing Research Conduct Using eConsent
The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.
Onboarding & Training for Clinical Research Professionals
The webinar will cover strategies for new hires joining the clinical trial industry and key topics to include in your onboarding plan.
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.
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.
Bridging the Gap: A Standardized Approach to Clinical Trial Document Management
Representatives from the Advarra Site-Sponsor Consortium will discuss a standards-based integration and automation of research technology.
Beyond Pharmaceuticals: Research Involving Cosmetics, Conventional Foods, and Dietary Supplements
Explore regulatory frameworks applicable to research involving cosmetics, conventional foods, and dietary supplements.
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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