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Responsible Conduct of Research (RCR) Basic
The National Institutes of Health (NIH), National Science Foundation (NSF), and U.S. Department of Agriculture (USDA) require certain categories of re...
Sponsor-Patient Engagement: How Patients Shape Clinical Development
Sponsor-patient engagement can play a pivotal role in the development of safe, effective, and clinically relevant new medicines. Increasingly, clinica...
Disaster Planning for the Research Enterprise
Disaster preparedness and business continuity planning are essential for any research organization and required for organizations that receive Nationa...
CIP Course for Advanced Learners – Research with Vulnerable Populations and Consent Topics
The course is intended for currently Certified IRB Professionals (CIPs) seeking CIP continuing education (CE) credits for recertification. These modul...
Essentials of Statistical Analysis (EOSA)
This course provides a comprehensive introduction to statistical analysis, including foundational and advanced topics. View Series Page for FAQs
Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov
Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov is a video-enhanced guide to compliance with the FDAAA Final Rule and NIH ...
Biotility: Good Documentation Practices (GDP)
Good Documentation Practices (GDP) are critical for compliance with current Good Manufacturing Practices (cGMP) regulations and within organizations i...
ClinicalTrials.gov Enforcement: An Update
Recently, there have been updates to ClinicalTrials.gov enforcement and various initiatives to drive transparency. Institutions are challenged to buil...
Managing Risk by Contract – Sponsor Perspectives on Clinical Trial Agreements
Protracted clinical trial agreement (CTA) negotiations often delay the start of a study. Understanding each party’s motivation and expectations faci...
Responsible and Ethical Conduct of Research (SBIR/STTR)
Federal funding agencies, including the National Institutes of Health (NIH), National Science Foundation (NSF), and U.S. Department of Agriculture (US...
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