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Billing Compliance: Step-by-Step
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INFORMATION FOR
About YSM
Faculty
Staff
Students
Residents & Fellows
Patients
Researchers
Alumni
Home
A to Z List of Services
General Resources
IND/IDE Support
IND Information
IND Training
IDE Information
IDE Training
Single-Patient Expanded Access
IND/IDE Support Path
Project Lifecycle
IND Training
To receive credit for the IND training module, please
visit Workday Learning
. You can watch the training video and complete the quiz.
IND Sponsor-Investigator Overview
Watch the video, then complete the quiz.
Log on to Workday Learning
FDA Websites
21 CFR 312: Investigational New Drug Application
Investigator-Initiated Investigational New Drug (IND) Applications
MedWatch Forms for FDA Safety Reporting
IND Application Reporting: Annual Reports
IND Application Reporting: Information Amendments
IND Application Reporting: Protocol Amendments
General Instructions – for Form FDA 3500A MedWatch (for Mandatory reporting)
FDA Guidance Documents
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
Safety Reporting Requirements for INDs and BA/BE Studies
A Risk-Based Approach to Monitoring
Financial Disclosure by Clinical Investigators
Protecting the Rights, Safety, and Welfare of Study Subjects
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