Research Articles
Protocol Amendment Tracking: Strategies to Manage Changes, Reduce Costs and Accelerate Drug Development
For researchers and drug development professionals, protocol amendments are a costly and time-consuming reality, with 76% of clinical trials requiring changes that cost between $141,000 and $535,000 each.
Administrative Letter vs. Full Protocol Amendment: A Strategic Guide for Clinical Researchers
This article provides clinical researchers and drug development professionals with a comprehensive guide to navigating the critical decision between submitting a full protocol amendment and an administrative letter.
A Researcher's Guide to Documenting Protocol Changes for IRB Review
This guide provides researchers, scientists, and drug development professionals with a comprehensive framework for navigating the process of documenting and submitting changes to research protocols for IRB review.
Strategic Implementation of Protocol Amendments in Multi-Site Clinical Trials: A Guide to Minimizing Costs and Maximizing Compliance
This article provides a comprehensive framework for researchers, scientists, and drug development professionals tasked with managing protocol amendments across multiple clinical trial sites.
How to Write a Protocol Amendment for IRB Submission: A Step-by-Step Guide for Researchers
This comprehensive guide provides researchers, scientists, and drug development professionals with a complete framework for successfully preparing and submitting protocol amendments to an Institutional Review Board (IRB).
Navigating New Investigator Protocol Amendments: A Comprehensive Guide for IND Sponsors
This article provides a definitive guide for clinical researchers and drug development professionals on the requirements, procedures, and best practices for submitting a 'New Investigator' protocol amendment to an active...
Immediate Hazard Protocol Changes in Clinical Trials: A Guide for Researchers to Ensure Subject Safety and Regulatory Compliance
This article provides a comprehensive guide for clinical researchers and drug development professionals on managing protocol changes to eliminate immediate hazards to trial subjects.
Change in Research (CIR): A Complete Guide to Definitions, IRB Submissions, and Best Practices
This article provides a comprehensive guide for researchers, scientists, and drug development professionals on Changes in Research (CIR).
Navigating the IRB Amendment Process: A Strategic Guide to Study Modifications
This article provides researchers, scientists, and drug development professionals with a comprehensive guide to the Institutional Review Board (IRB) modification process.
A Researcher's Guide to Submitting an IRB Protocol Amendment: Streamlining Compliance and Study Integrity
This guide provides researchers, scientists, and drug development professionals with a comprehensive roadmap for successfully submitting a protocol amendment to an Institutional Review Board (IRB).