Clik here to view.
BRANY Announces Launch of Informed Consent Builder Tool
For Immediate Release January 27, 2023 BRANY Announces Launch of Informed Consent Builder Tool New cloud-based application improves collaboration in developing compliant informed consent forms for...
View ArticleTips for Writing Informed Consent Forms
Along with writing a clinical research protocol, an investigator is also responsible for writing the informed consent form. These are subject to IRB approval. Informed consent is a process, not a...
View ArticleDiversity and Inclusion in Clinical Trials Continues to be a Challenge
Despite the ongoing effort of the FDA and other regulatory agencies, as well as industry associations, sponsors, and research institutions, the U.S. continues to fall short in meeting diversity and...
View ArticleFDA Issues Draft Guidance on Decentralized Clinical Trials
This week the U.S. Food and Drug Administration released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding decentralized clinical trials...
View ArticleFDA Issues Guidance for Clinical Trials that Research Psychedelics
Last month, the U.S. Food and Drug Administration published new draft guidance for researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including...
View ArticleEssential Elements of a Clinical Trial Regulatory Binder
In clinical research, maintaining accurate and organized documentation is essential to ensure the safety of participants and the integrity of the trial. Regulatory binders play a pivotal role in this...
View ArticleDecentralized Clinical Trials — A Round-Up of Public Comments on FDA Draft...
Ever since the FDA issued draft guidance in May regarding decentralized clinical trials (DCT), the public has been submitting their comments and feedback, as well as requesting clarity on certain...
View ArticleClik here to view.
September 1, 2023, marked the 25th Anniversary of BRANY’s entrance into the...
On September 1, 1998, BRANY’s forward-thinking owners, Icahn School of Medicine at Mount Sinai, Montefiore Medical Center, New York University Grossman School of Medicine, and Northwell Health, all...
View ArticleFDA Releases Guidance on Informed Consent
This article reviews the FDA’s recent guidance for informed consent, and what should be included. In August 2023, the FDA released guidance intended to assist institutional review boards (IRBs),...
View ArticleIs Your Clinical Research Site GCP-Ready?
Essentials for Regulatory Compliance Good Clinical Practice (GCP) guidelines provide an ethical and scientific quality standard for investigators, sponsors, monitors, and institutional review boards...
View Article