Aligning Institutional Policy With System Updates: A Practical Guide
Aligning Institutional Policy With System Updates: A Practical Guide Keep institutional policies, research administration workflows, and technology aligned as your
IRB
When Are Adaptive Designs Best Suited for Oncology Trials?
Adaptive study designs are best suited for oncology clinical trials when meaningful uncertainty exists and a protocol can prospectively use
Types of Audits in Clinical Trials
Clinical trial audits are independent quality assurance evaluations of trial activities, records, systems, facilities, and organizations. The main types include:
Frequently Asked Questions About Investigator-Initiated Trials (IITs)
Investigator-initiated trials (IITs) play a critical role in advancing clinical research by allowing investigators to pursue important scientific questions beyond
IRB Reportable Events Checklist
Determining whether an event requires prompt institutional review board (IRB) reporting is an important part of protecting research participants, supporting effective
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
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