Showing results for "NCT03411733%20enrollment%20data%20site:clinicaltrials.gov"

Transparency in Clinical Research: ClinicalTrials.gov in Context
Discusses the evolution of clinical trial registration and summary results information submission requirements, and the importance of transparency in ...
ClinicalTrials.gov Enforcement: An Update
Presented by: Anthony Keyes, MBA, PMP - Johns Hopkins University Learning Objectives: Review recent FDA notices of noncompliance. Ident...
ClinicalTrials.gov and Informed Consent
Reviews clinical trial registry disclosure language requirements in the informed consent form (ICF) for clinical trials subject to FDA regulations and...
Best Practices for Clinical Site Selection
Overview Clinical trials are expensive and labor-intensive. Failures within the clinical trial process result in a huge loss of valuable resources an...
Understanding the Specific Roles and Responsibilities Involved in the Clinical Monitoring Process
Overview: Clinical Trial Roles and Responsibilities A clinical monitoring plan is a carefully crafted template for each unique clinical study t...
Understand the Difference Between FDA-Cleared and FDA-Approved Medical Devices
U.S. FDA Medical Device Oversight: Overview Distinguishing the terms “FDA-approved” and “FDA-cleared” is important. This article will review ...
Food Scarcity and Housing Insecurity on Campuses
Introduction During a recent CITI Program podcast, Mary Haskett, PhD, a professor in the Department of Psychology at North Carolina State University ...
HIPAA Regulations and Implications for Your Institution
Since the Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996, federal and state agencies have developed and refin...
A 3-Step Plan to Set Up Your Clinical Trial Site for Success in the New Year
Overview Ever heard the term fail-forward? Many accounts of failed clinical trials have been reported - some of which resulted in costly delays...
Uses of AI in Drug Development
Introduction The potential for artificial intelligence (AI) and machine learning (ML) applications in the scope of the drug discovery market reached ...

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