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Columbia University Human Research Protection Program

Policies and Guidance

Selected University Research Policies & Guidances

    Risk Management Procedures for International Research and Service Projects

    Short-term Visitors in Research-related Activities Guidelines  

    Sponsored Projects Handbook

    Clinical Research Handbook

    CUMC Compliance Program for FDA-regulated Human Subjects Research

    Clinical Trials Monitoring Assistance Program for FDA Regulated Human Subjects Research

    

  • Conflict of Interest Policies

    Columbia University Policy on Financial Conflicts of Interest and Research

    FDA Draft Guidance: Financial Disclosure by Clinical Investigators

    Guidelines for Situations Involving Potential Conflicts of Interest Between Scholarly and Commercial Activitie

    Statement of University Policy on Conflicts of Interest

 
  • New York Presbyterian Hospital (NYP) Policies

    NYPH Policy: Use and Control of Investigational Drugs

    NYPH Policy: Emergency Use of an Investigational Drug or Biological Product

    Listserv message (July 9, 2009) regarding NYP Safety Reporting for Research Studies

             Incident Reporting to the New York State Department of Health  

             Serious Adverse Events/Sentinel Events (SAE/SE)

    NYPH Policy: Research Drugs (Investigational or Commercially Available) from Protocols Originating at Other 

    Institutions

  • CUMC Research Pharmacy Policies

     Investigational Drugs- Inpatient

     Investigational Drugs- Outpatient

  • WIRB Review

    Memo Regarding Policy for Review of Research by Western IRB

   

    For research safety policies please consult with the Environmental Health and Safety website

IRB Policies, Procedures, and Guidance

  Table of Contents

HRPO Process Updates

Process Updates - August 27, 2014

 

General

Center for Drugs Evaluation and Research

CDER Guidance Documents
Content and Format of IND Applications for Phase I Studies
Emergency Use of an Investigational Drug or Biologic

FDA Guidance – Frequently Asked Questions: Statement of Investigator (Form FDA 1572)
Form FDA 1571

Form FDA 1572

IND Exemptions for Drugs or Biological Products in Cancer Treatment

IND Safety Reporting Requirements

Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
Medwatch

Center for Devices and Radiological Health

IDE Policies
Emergency Use
Compassionate Use (or Single Patient/Small Group Access)
Treatment Use
Continued Access
Humanitarian Use Devices

In Vitro Diagnostic Products (IVDs) - Draft Guidance

Guidance for IRBs and Clinical Investigators

        Data Retention When Subjects Withdraw from FDA_Regulated Clinical Trials

        IRB Responsibilies for Revieweing the Qualifications of Investigators, Adequacy of Research Sites, and the

Determination of Whether an IND/IDE is Needed

        Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors- FDA Inspections of Clinical

Investigators

        Informed Consent Elements

        Investigator Responsibilities

        List of Guidances for IRBs, Investigators, & Sponsors

     Risks

Antiretroviral Pregnancy Registry (registry for teratogenetic effects of antiretroviral agents)

 

  • Department of Defense

Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

Department of the Navy HRPP Training and Education Guidance

International Standards

CIOMS

International Conference on Harmonization (ICH) Guidances

World Medical Organization (WMA)

World Health Organization (WHO)

OHRP's Compilation of International Standards for Human Subjects Protections

Related Information

Acronyms

HHS Reference Collection

History of Human Subject Protections

Timeline of Laws Related to the Protection of Human Subjects

Archive

Adverse Event Reporting Policy, 4/13/2004 version

Case Report Policy

Converting Attached Documents, October 2012

Data Security Plans Involving the Storage of Certain Electronic Research Data in Human Subjects Research, 2/1/2013

Enrollment of Non-English Speaking Subjects in Research, 12/6/2006 version

Human Embryo and Human Embryonic Stem Cell Research Special Operating Procedures

Informed Consent Policy, 5/8/07 version

Informed Consent Policy, 11/19/09 version

Informed Consent Policy; 4/1/10 version

Investigational Devices:

IRB Procedures for obtaining CMS Approval

IRB Standard Operating Procedures, 6/9/2008 version

IRB Standard Operating Procedures, 12/15/2008 version

IRB Standard Operating Procedures, effective 8/24/2009, revised 10/26/2011

Section IX, revised, effective 10/28/11; supercedes section within 8/24/09 version

IRB Standard Operating Procedures version 4, effective 6/12/2012

REVISED SOP Section IX, effctive 7/9/2012

Table of Contents for IRB SOP version 4, effective 6/12/12

Summary of SOP Changes

Noncompliance Policy, 1/23/2006 version

Noncompliance Policy, 12/1/2009 version

Noncompliance Policy, 2/24/2012 version

Noncompliance Policy, 11/15/2012 version

Policy on the Conduct of Research with Human Embryos and Human Embryonic Stem Cells (9/2006 version)

WIRB Review

 

 

 


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