Archieved Clinical Trials Seminar Series Sessions

Clinical Trials Seminar Series 2014-2015

Wednesday, September 10, 2014: What You Need to Know About Submitting Results to ClinicalTrials.gov

• announcement, 1 slide per page, 6 slides per page, NIH only videocast

Wednesday, October 1, 2014: Overview of the HHS Office of Research Integrity and Research Misconduct

• announcement

Wednesday, November 5, 2014: Conflict of Interest Policy Implementation

• announcement, 1 slide per page, 6 slides per page

Tuesday, December 9, 2014: Data Safety Monitoring Boards (DSMBs)

• announcement, 1 slide per page, 6 slides per page

Tuesday, January 13, 2015: Revised NIH Definition of Clinical Trials

• announcement, 1 slide per page, 6 slides per page
• Decision Tree
• Case Studies
• FAQs

Tuesday, February 10, 2015: Notice of Proposed Rule Making for FDAAA nd NIH Policy

• announcement, 1 slide per page, 6 slides per page (Note: For the case studies used in the presentation, please click the Case Studies link above from the January session)

Monday, March 10, 2015: NIH Policy of women and Minorities - Updates and Impact on NIH IRP

• announcement, 1 slide per page

Wednesday, April 15, 2015: TBD

• announcement, Guptil slides (CC), Huang slides (NHGRI), King slides (NCI), Beri slides (BTRIS), Dobbins slides (ct.gov)

Tuesday, May 12, 2015: Successful Coordination of Multi-site Investigator-Sponsor IND Clinical Trials

• announcement, 1 slide per page, 6 slides per page

Clinical Trials Seminar Series 2013-2014

Wednesday, September 25, 2013: Human Research Protection Program Certification: An NIH IRP Update (announcement; slides)
Tuesday, October 29, 2013: Institutional Review Boards (IRB's): Regulatory Requirements & Responsibilities (announcment; slides)
Monday, November 18, 2013: AAHRPP is Coming - Are You Ready? (announcement; slides)
Wednesday, December 18, 2013: The Globalization of Clinical Trials (announcement; slides)
Tuesday, January 28, 2014: Obtaining Proper Approval for Research that does not Require IRB Approval (announcement, slides)
Tuesday, February 25, 2014: AAHRPP Site Visit Follow-up (announcement; slides)
Monday, March 17, 2014: Employees as Research Participants (announcement; slides) Rescheduled for May 21, 2014
Tuesday, Apirl 22, 2014: NIH Healthy Volunteer Program (announcement; slides)
Wednesady, May 21, 2014: Employees as Research Participants (announcement; slides)
Wednesady, June 18, 2014: Integrity in Research: Individual and Institutional Responsibility (announcement; slides)

Clinical Trials Seminar Series 2012-2013

September 25, 2012: Overview and Role in Intramural Research Program Compliance with FDAAA
October 23, 2012: Regulatory Obligations for the Investigator- Sponsored Research: An FDA Perspective
November 28, 2012: Understanding Decisional Capacity- What to Look for and Who to Call - CANCELLED (see May 2013)
December 10, 2012: Implications of Genetics and Genomics on Research and Practice
January 15, 2013: Good Clinical Practice (GCP)
February 11, 2013: Unanticipated Problem Reporting
March 20, 2013: Radiation Safety Committee
April 23, 2013: Therapeutic Misconception
May 15, 2013: Understanding Decisional Capacity - What to Look for and Who to Call
Article: A guide to informed consent for clinical-investigators
June 10, 2013: Shedding Some Light on FDA Inspections of Clinical Drug Trials (6 slides per page)