Translational Research Program
Regulatory Resources
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One of the major challenges that researchers face when beginning a clinical research project, is navigating through the regulatory approval process. An essential part of responsibly conducting research is ensuring that your study is in compliance with federal, state, local and hospital regulations and policies. Depending on the type of research that you are conducting different types of regulatory review and approval must be granted before you begin your project. Below are some resources about the possible required regulatory procedures that your project may require. If you have any questions about regulatory process for your clinical research project please contact Matt Wladkowski, (Matthew.Wladkowski@childrens.harvard.edu or 617-919-2777), in the Translational Research Program.
IND/IDE Service
IND/IDE Service Informational Sheet
IND/IDE Registry
Basics
FAQ about Drugs Studies (IND)
FAQ about Medical Device Studies (IDE)
Drug Research
Does my study need an IND?
IND Determination Checklist.pdf
IND Content and Format Requirements
What are the responsibilities of the Investigator for an IND?
What are the responsibilities of the sponsor for an IND?
What is a Pre-IND Meeting?
Pre-IND Meeting Package
Medical Device Studies
IDE Content and Format Requirements
Is my device a Non-significant Risk Device?
IDE Early Access for Medical Devices
What is a Humanitarian Use Device?
IND Reporting Requirements
IND Reporting Requirements Schedule
IND Annual Reports
IND Annual Report Checklist
IND Amendments
IDE Reporting Requirements
IDE Sponsor Reporting Requirements
IDE Investigator Reporting Requirements
FDA Forms
FDA Form 1571 - IND coversheet
FDA Form 1572 - Statement of Investigator
FDA Form 3454 - Financial Interests (Sponsor)
FDA Form 3455 - Financial Interests - (Investigator)
FDA Form 3674 - ClinicalTrials.gov
FDA Form 3500A - MEDWATCH
FDA Guidance Documents and Resources
New Drug Approval Application Process
21 CFR Part 312 - Investigational New Drug Application
Content and Format of INDs for Phase I Studies
Guidance on IDE Policies and Procedures
Guidance for Investigator Responsibilities
Guidance for the Monitoring of Clinical Investigations
Pre-IND Meeting
Gene Therapy Studies - Appendix M
Regulatory Review
Children's Committee on Clinical Investigation (IRB)
Harvard Biosafety Committee (COMS)
Food and Drug Administration (FDA)
NIH - Office of Biotechnology Activities (RAC)
Orphan Product Information
How to Apply for Designation as an Orphan Product
Tips for Submitting an Application for Orphan Designation
Pediatric Drug Development and The Orphan Drug Act Incentives
