Research Compliance
Simple Strategies for Identifying Research Compliance Blind Spots
David Staley authored the article Simple Strategies for Identifying Research Compliance Blind Spots in Compliance Today.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
Setting Yourself up for Success During Investigator-initiated Trials
This eBook shares tips and best practices to guide researchers through the investigator-initiated trial process while staying compliant.
Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software
Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.
How Paper and Electronic Source Data Meet ALCOA-C Principles
ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?
Budget Negotiation 101
Clinical trial costs vary from each site, and a prolonged budget negotiation process can affect the startup timeline.
Informed Consent Writing Tip Sheet
Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it.
Inspection Readiness: Before. During. After
This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.
How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
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