Sites
The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.
The Importance of Strategic Planning for Long-term Training Success
Explore key strategic planning actions to foster a proactive mindset when designing training and documentation.
Strategic Training: Navigating Organizational Challenges
It’s important to define what falls into training and what doesn’t. The key is to know what the training is intended to accomplish.
Key Items Auditors Look for When Reviewing an Investigator Site File
Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:
Planning for Complex Change at Your Organization
Navigate the ever-changing landscape of innovation and technology in clinical operations by discovering strategies to help your organization.
Interim Staffing: Reinvigorating Your Human Research Protections Program
Uphold research compliance best practices with an innovative approach to HRPP.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.
Inside Study Activation: Budgeting Takeaways
Learn how sites, sponsors, and CROs can work together to help study activation, specifically within budgeting and contracting.
Reporting to the IRB: Investigator Noncompliance
Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.
Striking the Balance: Ethics, Inclusion, and Vulnerability in Research
Explore the ethical tensions between including under-represented communities and ensuring vulnerable participant populations are appropriately protected.
SAE Reporting and the IRB: Adverse Events in Drug Studies
Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.
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