When do I Need a DMC?
Understanding when to use a Data Monitoring Committee (DMC) is crucial for participant safety. A DMC independently reviews data to spot early evidence of harm.
Reviews
The Importance of Keeping DSMBs Independent
Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.
Beginner’s Guide to Connected Clinical Research Ecosystems
A well-managed, participant-centric clinical trial has many moving parts, and easy access to the right technologies, services, and community of
Research Equity and Enrolling Non-English Speakers
Informed consent, a cornerstone of ethical research, involves describing important elements of research in a way that permits participants or
US Medical Device Regulation 101
Download a larger version of the infographic. IRBs and Researchers: Know Your US Medical Device Documentation Speed the IRB
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Phase I research demands careful IRB oversight, balancing participant safety with timely reviews. Proactive strategies can help address its unique challenges.
Beginner’s Guide to Minimal Risk Research
When an institutional review board (IRB) determines research is “minimal risk” (as defined in Department of Health and Human Services
Ethical Issues in the Design and Review of Decentralized Research
Learn how to navigate ethical issues in decentralized research with insights for sponsors and IRBs on design and deployment strategies.
Diversity and Inclusion: Who is Responsible – Site, CRO or Sponsor?
Diversity and Inclusion: Who is Responsible – Site, CRO or Sponsor? Attaining a diverse trial patient population is crucial to
IRB Review of Social Media Recruitment and Retention Programs
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations
The Value of Early Engagement with Your IRB
It’s no secret that in clinical research, everything moves at a quick pace – and that doesn’t stop when working
Why Institutions Should Consider an Externally Administered IBC
Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.