What Is the Difference Between an SAE, AE, and UADE in Clinical Trials?
Adverse events (AEs) are untoward medical occurrences in participants receiving a study intervention, regardless of whether they’re related to the study. Serious adverse
IRB
Why IRBs Ask for Certified Translations of Informed Consent Forms: Regulation, Guidance, and Practical Reality
Understanding the regulatory foundation behind translated informed consent documents and why many institutional review boards (IRBs) require certificates or attestations of translation.
How Integrated IRB and IBC Administration Facilitate a New Era of Interventional Genetic Therapeutics
Gene therapies and gene-based therapeutics are giving way to a new era of interventional genetics. Integrated ethics review and biosafety review have developed into an operational advantage to facilitate this
Sponsor’s Guide to IRB Approval (Part VI): After IRB Approval: Compliance, Multi-Site Oversight, and Turning Review into a Strategic Advantage
IRB approval is a critical milestone in clinical research, but it isn’t the end of the oversight process. For sponsors, approval marks
Do DSMBs Need AI Expertise?
Rethinking oversight as clinical trials become more data-driven and algorithm-informed As artificial intelligence (AI) becomes more embedded in clinical trial
Sponsor’s Guide to IRB Approval (Part V): How to Speed Up IRB Approvals
Institutional review board (IRB) approval is a critical milestone in clinical research, but it can also become a source of
Why Should Local IRBs and HRPPs Collaborate with External IRBs?
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
Sponsor’s Guide to IRB Approval (Part IV): Preparing IRB Documents That Prevent Delays
A strong protocol and well-drafted consent form are essential, but they are not enough on their own to support a
Does mRNA Require IBC Review? How the NIH Guidelines Apply to Clinical Trials
Let me start with a question I get more and more frequently from research sites as mRNA continues to expand
Sponsor’s Guide to IRB Approval (Part III): Building an IRB-Ready Informed Consent
For sponsors, informed consent is one of the most visible signals of study quality during IRB review. It’s also a
When Do Clinical Trials of mRNA Products Fall Under IBC Review
Discover how AI and analytics are transforming clinical trial operations, from study startup to accrual workflows, in this insightful whitepaper.
Sponsor’s Guide to IRB Approval (Part II): How to Draft a Clinical Trial Protocol That Stands Up to IRB Scrutiny
A strong clinical trial protocol does more than describe how a study will run. It also helps reviewers understand why