Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the first drug to treat children with
Reviews
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed
Unpacking IRB Innovations for Decentralized Clinical Trials
In the blink of an eye, the world has gone digital. So many tasks which used to require going to
Informed Consent Writing Tip Sheet
Crafting informed consent forms requires balancing regulatory compliance with participant understanding, ensuring consent is both meaningful and legally sound.
How the IND 30-day Hold Impacts Clinical Trial Activities
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
Safe Sharps Handling When Dispensing Investigational Products
Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug
What Does an Endpoint Adjudication Committee (EAC) Do?
Learn how Endpoint Adjudication Committees ensure safe study conduct, mitigate participant risks, and provide unbiased medical event reviews.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Discover survey findings on trial selection, from cumbersome feasibility questionnaires to improving transparency and site opportunities.
Clean Bench vs Biosafety Cabinet: What’s the Difference?
Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use with biological materials and the
CBD Research: A Dive into the Regulations of Cannabis Research
Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis
Short Form Consents and the Unexpected Non-English Speaking Participant
Short form consents provide a crucial bridge for unexpected non-English speaking participants, ensuring informed consent remains accessible when translations aren’t readily available.
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.