Informed Consent Writing Tip Sheet
Crafting informed consent forms requires balancing regulatory compliance with participant understanding, ensuring consent is...
FEATURED E-BOOK
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
How the IND 30-day Hold Impacts Clinical Trial Activities
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged...
Streamline Study Startup with Improved Site Selection & Feasibility
Site selection for clinical trials is often one of the biggest headaches for pharmaceutical...
Scale Your Training Program: 3 Successful Models
From live sessions to eLearning, scalable training models ensure clinical research teams stay effective,...
Beginner’s Guide to 21 CFR Part 11 Compliance
Ensuring 21 CFR Part 11 compliance in research software protects data integrity, security, and...
Regulatory, Clinical, and Quality Considerations for Device Research
In response to a growing demand for faster, approved, and cost-effective medical devices for...
Safe Sharps Handling When Dispensing Investigational Products
Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a...
Informed ConsentParticipant EngagementResearch ComplianceResearch OperationsSite/Sponsor Relationships
Regulatory and Ethical Considerations for eConsent in Research
IRB oversight, identity verification, and comprehension checks are critical in eConsent, ensuring ethical and...
An Evolving Regulatory Environment for Rare and Orphan Diseases
Rare diseases affect fewer than 200,000 people each, totaling around 30 million in the...
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