IRB approval is a critical milestone in clinical research, but it isn’t the end of the oversight process. For sponsors, approval marks
Institutional review board (IRB) approval is a critical milestone in clinical research, but it can also become a source of
Multisite research and clinical trials increasingly rely on a single IRB (sIRB) for review. This increase reflects federal mandates, sponsor expectations, and the operational realities of modern multisite or cooperative research. For institutions with a local
A strong protocol and well-drafted consent form are essential, but they are not enough on their own to support a
For sponsors, informed consent is one of the most visible signals of study quality during IRB review. It’s also a
A strong clinical trial protocol does more than describe how a study will run. It also helps reviewers understand why
Introducing the “‘Sponsor’s Guide to IRB Approval’“ Institutional review board (IRB) approval protects the rights, safety, and welfare of research participants, and
Artificial intelligence in clinical research is expanding rapidly, bringing both excitement and ethical challenges. How can IRBs ensure responsible oversight?
When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.
Our webinar proved so popular, we thought a deeper dive would be appropriate. In this post we explore some key issues IRBs face when reviewing research involving virtual trial technology.
How do remote visits and data collection impact participant monitoring? What techniques will satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world?
