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
sponsors
Sponsor’s Guide to IRB Approval (Part III): Building an IRB-Ready Informed Consent
Sponsor’s Guide to IRB Approval (Part III): Building an IRB-Ready Informed Consent For sponsors, informed consent is one of the
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
Sponsor’s Guide to IRB Approval: What Every Sponsor Needs to Know Before Submitting a Study
Introducing the “‘Sponsor’s Guide to IRB Approval’“ Institutional review board (IRB) approval protects the rights, safety, and welfare of research participants, and
Clinical Trial Budget Negotiations: A View From Each Side
Budget negotiation success hinges on clear communication and early resource sharing, helping sites and sponsors align expectations and avoid costly delays.
Good Manufacturing Practices: When Do They Apply?
Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.
GxP Audits Guide for Successful Clinical Trials
A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator sites, vendors, and internal processes in clinical trials.
Key Items Auditors Look for When Reviewing an Investigator Site File
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.
Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
Reporting to the IRB: Investigator Noncompliance
We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations, but lack a definition; some are covered in regulatory guidance documents; and some are “industry standard” that are neither an IRB regulation or IRB best practice/guidance. In this blog, we’ll look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
SAE Reporting and the IRB: Adverse Events in Drug Studies
Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible