Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g.,
Reviews
Your Guide to sIRB Mandates
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.
Why Keep HIPAA Separate from the Informed Consent Form
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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
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.