Monthly Seminar Series

A seminar series entitled, "Achieving High Quality Clinical Research" is held the second Tuesday of each month, September through June. The objectives of the series are to educate physicians, Clinical Research Coordinators, and support staff; 1) in methods of conducting studies in compliance with Good Clinical Practices (GCP) standards and; 2) in ways to protect the rights and welfare of human subjects involved in research.

Below are titles of some of our previous seminars:

2009

• UR Policy on Social Security Numbers and Personal Identifying Information
• Innovation at a Cross Roads: Economic and Political Perspectives On the Drug Development Process
• Health Research Management for the URMC Study Coordinator: Elements of Project Development and Initiation
• FDA Draft Guidance May 2007: Protecting the Rights and Safety and Welfare of Subjects: Supervisory Responsibilities of Investigators

2008

• 7 Steps to a Successful Clinical Trial
• Discussion of Provacy and Security Topics for Researchers
• Top Ten Bioethics Lessons Learned From the Stem Cell Debates
• SOPs for Conducting CLinical Trials

2007

• RSRB Electronic Submission System -Tips for a Timely Turn-Around
• Ethical Issues in International Studies: Stories from the Field
• The Placebo Effect
• Every Researcher's Responsibility Regarding Misconduct and Fraud in Clinical Research
  
• Beaumont and Research Ethics
• Racial and Ethnic Diversity in Clinical Research
• Institutional Biosafety Committee & Human Use Radiation Committee/Radioactive Drug Research Committee

2006

• Rush University Medical Center: Lessons in Clinical Trial Billing Teleconference Overview
• Face Transplants:  Ethical Concerns
• Medicare Secondary Payor Rules in the Clinical Trial Context: Update on Current Government Interpretation and Guidance on Addressing Financial Consequences
• Potential Problems in Consulting Agreements
• Recruitment and Retention in Clinical Trials: What Works, What Doesn't and Why
• Deploying New Technologies to Speed Clinical Development-Electronic Data Capture and 21CFR Part 11-the Promise, the Perils, and the Practical
• Clinical Translational Science Institute (CTSI) - Regulatory Knowledge and Support Program

2005

• How to: RSRB Electronic Submission System
• HIPAA Security Update
  Responding to Investigator-Initiated Research Problems: A Scenario-Based Audio Seminar
• A Brief History of Ethical Issues in Human Subjects Research
• Insider Trading and Clinical research: Improper Uses of Clinical Trial Data
• FDA Inspections of Clinical Sites - FDA Expectations, and How to Prepare for an FDA Inspection
• PRIM&R Webinar "Institutional Oversight of Human Embryonic Stem Cell Research: Roles of ESCROs, IRBs, IACUCs, and IBCs"
• Disaster Mental Health: Public Mental Health & Research Challenges
• Best Budget Practices

2004

• Using the Internet as an Effective Tool for Patient Recruitment and Strategic Decision Making
• The Six Phases of a Successful Research Budget
• Research Subjects Review Board (RSRB) Update
• The FDA Inspection Process Directly from the FDA
• HIPAA Security for Clinical and Database Research
• HIPAA Privacy & Security Update

2001 - 2003

• Strategies for Effective Study Subject Recruitment
• Issues Concerning the Control of Investigational Study Drug Supplies at the Study Site
• Sorting Out and Tracking Billable and Non-Billable Protocol Charges
• The FDA from the Inside
• SOPs and Training: Keys to Success
• Clinical Trials...Our Hope for the Future
• Research Risk and Non-Compliance - Implications for 2002
• Research Ethics for Mental Health Science Involving Ethnic Minorities
• Oops! What to do When There is a Study Protocol Violation
• Industry Perspective on Clinical Research
• Advertising for Subject Recruitment in Clinical Trials
• Human Subjects Protection Update including Introducing the New University Office: "Office for Human Subject Protection"
• A plan for Clinical and Community Health Science at the University of Rochester
• Investigator Initiated Research
• HIPAA - An Introduction to Impact on Research
• Panel Discussion: Impact on Research at URMC & Strong Health
• Life Cycle of a Clinical Trial
• Listing Clinical Trials on Stronghealth.com
• Privacy Concerns and HIPAA - Online Forms
• SOPs: What are they and why do we need them
• Protocol Writing 101

1996 - 2000

• Changes and Opportunities in the Clinical Research Industry
• Preparing a Consent Form: Regulatory Requirements and Review of a New Consent Form Template
• Protocol Preparation: Regulatory Requirements and The RSRB Perspective
• Patient Recruitment and Retention Techniques
• How to Design and Manage A Sponsor-Friendly Budget Without Losing Your Shirt
• Writing Consent Forms That Inform
• Cognitive Functioning at Critical Moments in Research: Consent and Release
• Using Computer Technology to Enhance Investigator/Sponsor Relationships and Improve the Quality of Clinical Studies
• Research Subjects Review Board: Progress Report
• A Panel Discussion with Members of the Research Subject Review Board
• Drug Supply Issues for Clinical Trials
• Working with the Office of Research and Project Administration (ORPA)
• Legal Issues Associated with Conducting Clinical Trials
• Investigator IND: How to Work Through FDA Regulations
• Publishing and Presenting Sponsored Studies: What do you need to Know?
• FDA Inspections of Clinical Investigators
• Clinical Research at the UR - Past, Present and Future
• Scientific Misconduct
• Rights and Rituals of Informed Consent: Patient/Participant Consent Concerns
• Adverse Events in Clinical Studies: The Regulations, Responsibilities, and Process
• Human Subject Protections Program
• Clinical Trial Charges: Who should be billed?
• Fostering Good Relationships with Industry Sponsors
• New System for Submission of Industry-Sponsored Clinical Trials to WIRB: What, Why, How, and When?
• Enhancing Support for Research Through Advocacy
• To Bill or Not to Bill? That is the Question - An Interactive Session on Research Billing Practices
• Informed Consent: Preparation and Presentation
• Legal Issues Related to Compensting Research Subjects for Injuries Sustained as a Result of Participation in Research Protocols
• New Masters in Public Health in Clinical Investigations
• Monitoring Industry Sponsored Clinical Trials: The Perspective of a Clinical Research Associate
• Adverse Event Reporting to the Research Subject Review Board Offices
• Sound Clinical Trial Practices in the Era of Gene Therapy - A Drug Information Association (DIA) sponsored satellite conference with the FDA Center for Biologics Evaluation and Research (CBER)
• Informed Consent: The Form and the Process
• Compensation for Injury: A New Procedure
• The Federal Government and Clinical Trials: Billing and Related Issues of Importance to Researchers