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Announcements
„ Important Announcement Regarding IRB Committee Meetings
„ Information Sheet Guidances Guidance for Institutional
Review Boards, Clinical Investigators, and Sponsors
„ Cancer Trials Help
Submission to the IRB
„ 1572 Requirements
„ Instructions for IRB Submissions
„ Preparing and Submitting Your Proposal Review Package
„ Obtaining Approval from and Complying with IRB
Decisions
„ 2009 Submission Deadlines, Meeting Dates and Locations
„ 2010 Submission Deadlines, Meeting Dates and Locations
„ How to Submit Revisions
„ Extracting Documents from a .pdf File
IRB Review Process
„ IRB
Review Process
„ Research that Requires IRB Approval
„ Research that Does Not Require IRB Approval (Exemptions
from IRB Approval)
„ Expedited
Review
„ Emergency Use of an Investigational Drug or Biologic
„ Emergency Use of Unapproved Medical Devices
„ Exception from
Informed Consent for Planned Emergency Research
„ Treatment Use of Investigational Drugs
„ Off-Label and Investigational Use of Marketed Drugs,
Biologics and Medical Devices
„ Device
Studies
„ Special
Classes of Subjects
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Education
„ CITI Training Program Instructions
„ Policy on Required Training
„ Current
Issues in Research
„ Engaging African Americans In Research
„Clinical Trials Billing – Presentation by Mark Barnes
April 18, 2006
CREDIT
„ Creating a Protocol Shell in CREDIT
„ Uploading a Consent Form into CREDIT
„ Viewing an Electronic Consent in CREDIT
Resources
„ Medical
Library “Survival Kits”
„ OHRP
Quality Improvement Activities Frequently Asked Questions
„ Lay
Language Dictionary
„ Clinical
Trials.gov
„ FDA Guidance on Data
Monitoring Committees
„ NIH Policy for Data and Safety Monitoring
„ DMC
Charter
„ FDA Inspection of Christiana Care Health System IRB
January 2009
„ International Compilation of Human Subjects
Protections, US Office for Human Research Protections (OHRP) November 2008
„ Principles on Conduct of Clinical Trials – Communication of Clinical
Trial Results
„
Office of Research Integrity (ORI) Newsletter
„
OHRP
„ DHHS
„Office of Research
Integrity
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Policies
„ IRB Policies Homepage
„ Data Retention After Withdrawal
„ CCHS
Records Retention Policy
„ Research and Grant Management Standard Operating
Procedures
Useful Information
„ IRB Statement of Compliance
„ OHRP
Pamphlets: “Becoming a Research Volunteer: It’s Your Decision”
(English) “Ser Voluntario en Estudios Clinicos: Es Su Decisión”
(Spanish)
„ “What
You Should Know About Research Studies” from the Joint Commission
„ Definition of Research with Human Subjects
„ Ethics
in Research
„ Differentiation of Research from Performance/Quality
Improvement
„ Report Advises Ethics Overhaul to Curb Conflicts of
Interest
„ Clinicaltrials.gov
- What You Need to Know presented by Mark Barnes - April 28, 2009
„ FDA shoots down Northfield Labs' blood substitute
Review Process
„ Nursing
Researchers
„ Undergraduate
Researchers
„Investigator-Initiated Research
Federal Wide Assurance (FWA)
„ Current FWA Letter (.pdf format)
„ FWA Terms
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