NHSR, Exempt, Expedited, or Full Board? A Plain-Language Guide to Potential Review Pathways
Researchers often want to know early whether a study will be considered Not Human Subjects Research (NHSR), exempt, eligible for
Reviews
What Is ALCOA+? A Practical Guide for Clinical Research
Clinical research decisions are only as sound as the records supporting them, and that soundness begins with data integrity: the
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
Advarra AI Council Members Participate in a Panel at Northwestern University to Discuss the Impacts of AI on Biosecurity
What impact will advancements in artificial intelligence (AI) have on national security and global public health issues, particularly when it
The Data Monitoring Committee Charter Is Now a Strategic Governance Document
FDA’s 2024 draft guidance signals broader expectations for data monitoring committee (DMC) independence, communication, documentation, and sponsor decision-making. For sponsors and contract research organizations (CROs), now is
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
The Heart’s Broken Blueprint: Rewriting the Cardiovascular Playbook with Gene Therapy
Cardiovascular disease remains a worldwide challenge, causing undue strain on the health system and contributing substantial patient burden. For decades, our medical response has been
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