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 contact the Christina McCarthy: Christina.McCarthy@childrens.harvard.edu

CLINICALTRIALS.GOV

ClinicalTrials.gov: Review of Registration Guidelines

IND/IDE SERVICE

IND/IDE Service Informational Sheet

IND/IDE REGISTRY

Link to IND/IDE Registry - To request access please contact Christina McCarthy
Information and Instructions about the 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

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