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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.
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
On October 22, 2020, the FDA's VRBPAC met to discuss the development, authorization, and licensure of vaccines to prevent COVID-19.
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete.
Beginner’s Guide to Clinical Trial Performance Metrics
Learn what clinical trial performance metrics are, why they are important and which key metrics for clinical trials you should be measuring.
Unique Ethical Issues in Phase I Oncology Studies
An essential step in research, Phase I oncology studies raise unique ethical challenges for sponsors, investigators, and IRBs.
Informed Consent in Research and Individuals with Impaired Decision-Making Capacity
This blog outlines the principle of equitable selection and the requirement for additional safeguards for certain vulnerable groups.
Diversity, Equity, and Inclusion in Clinical Research
Achieving diversity, equity, and inclusion in clinical trials is vital for inclusive data, safe treatments, and addressing community-specific needs.
Electronic Platform Migration Complete
Advarra has successfully completed the migration of legacy study information to the Advarra CIRBI Platform. All IRB submissions are now managed through CIRBI.
Note to File Re: Statement of Investigator, Form FDA 1572 2018
Effective 2/5, Advarra IRB serves as the IRB providing oversight for the study(ies) listed on 1572s as under Schulman IRB oversight. Effective 5/1, Advarra IRB will serve as the IRB providing oversight for the study(ies) listed on 1572s as under Chesapeake IRB oversight. FDA does not require that an updated or new 1572 be completed to reflect this change.
Institutional Biosafety Committee Reviews 101
What is an IBC? How long does an IBC review take? Read our IBC 101 handout to get answers to some of your most frequently asked questions.
To Be Patient-centric, Be Site-centric
What does it mean to be “site-centric” as a step toward patient centricity? Patient centricity has long been a key goal in healthcare, as well as in clinical research. Read our latest blog on what it means to be site-centric as a step toward patient centricity.