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‘Let’s Talk Guidance’ Sessions

As part of ACRP’s commitment to preparing the clinical research community for the coming changes in the ICH E6(R3) Good Clinical Practice Guidelines, we have assembled a robust selection of sessions related to guidance and regulations. Many are part of the Regulatory & Compliance Journey—but others are not—so this curated list identifies all relevant sessions. Please visit ACRP’s Guidelines and Regulations Resource Center for timely updates and accurate information related to guidance changes.

 
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The Limits of "De-identification" in Clinical Research Data
Challenges and Solutions for Getting Physicians Involved in Clinical Trials
A Regulatory Framework for Testing Artificial Intelligence as a Medical Device
Clinical Research Billing Audits: Preparing Your Site for Compliance
Is Your Electronic Data Capture Fit for Purpose?
Keeping Up with the FDA's Changing Ways
Innovation in Investigational Product Management
Do Adaptive Designs and Protocol Modifications Mean Entirely New Trials?
FDA's Latest Guidance on Informed Consent: Reading Between the Lines
Inspection Readiness: It's All About the Data
The ABCs of Risk-Based Monitoring for Sites
Training for the Informed Consent Process: Going from Good to Great
Your Guide to 21 CFR Part 11 and Annex 11 Compliance
Comparing and Contrasting Approaches to In Vitro Diagnostics Research vs. Other Medical Devices
Compensating Research Subjects: The Fine Line Between Fairness and Inducement
How the New Single IRB Requirements Will Change Clinical Research