In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated sIRB for multisite research.
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the first drug to treat children with
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed
In the blink of an eye, the world has gone digital. So many tasks which used to require going to
Crafting informed consent forms requires balancing regulatory compliance with participant understanding, ensuring consent is both meaningful and legally sound.
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
Discover survey findings on trial selection, from cumbersome feasibility questionnaires to improving transparency and site opportunities.
Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis
Short form consents provide a crucial bridge for unexpected non-English speaking participants, ensuring informed consent remains accessible when translations aren’t readily available.
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.
