Orientation to Research Fundamentals (ORF) - CTSI November 11-12, 2020
Day 1: November 11, 2020 Time Title Speaker
8:15 Welcome and Introduction Teri Reiche
8:20 01 Role of a Research Coordinator Sue Clifton & Katelyn Collinger
8:35 02 Clinical and Translational Science Institute Dana Farrell
8:50 03 Overview of the Clinical Research Process Teri Reiche
9:15 04 Developmental Landmarks, Regulations, & Good Clinical Practice Kelly Dornin-Koss
10:10 05 Recruitment & Retention Judy Navratil
10:35 06 Study Documentation April Lehman
11:25 07 Standard Operating Procedures (SOPs) Shannon Valenti
12:25 08 Informed Consent Process Maggie Soncini
1:20 09 Working with the Human Research Protection Office (IRB) Melissa Miklos
2:05 BREAK 2:20 09 Working with the Human Research Protection Office (IRB) – Part 2 Melissa Miklos
2:50 10 Diversity and Inclusion in the Clinical Research Workforce Mario Browne
3:05 11 Pitt + Me: How to Use it Kerri Jackson
3:20 12 Pitt + Me: Marketing your Study Heather Rockwell
3:35 Wrap Up Teri Reiche Orientation to Research Fundamentals Updated
10.26.2020 Day 2: November 12, 2020 Time Title Speaker
8:15 Welcome Teri Reiche
8:20 13 Safety Issues Joseph Madia
9:20 14 Import/Export of Biological Agents & Dangerous Goods Shipping Rebecca Lingenfelter
9:35 15 Research Using eRecord Data & the Health Record Research Request (R3) team Jonathan Silverstein
10:05 16 Office of Sponsored Programs (Office of Research) Kristy Rizzo
10:40 17 COI Management and the Responsible Conduct of Research Jane Volk
11:15 18 Audits and Inspections Kelly Dornin-Koss
12:30 19 Devices, Drugs, and Biologics Nita Missig-Carroll
1:10 20 Investigational Drug Service (breakout session) Jennifer Kozar
1:10 21 Social, Behavioral and Educational Research (SBER) Studies (breakout session) Dana DiVirgilio
2:05 22 Vincent Payment Solutions George Cerminara
2:30 23 Human Gene Transfer & IBC Review Beverly Harding
2:45 24 Costs and Billing in Clinical Trials Laurie Rudzinski
3:05 Wrap Up Teri Reiche
The CTSI Orientation to Research Fundamentals Program is an intensive, two-day workshop which covers the basic concepts required to successfully coordinate a research study and provides an overview of the research resources and regulatory requirements for conducting clinical research at the University of Pittsburgh.
This workshop is intended for research professionals including faculty physician investigators and others with less than one year of experience in the University of Pittsburgh/UPMC clinical research environment.
The information presented at this CME program represents the views and opinions of the individual presenters, and does not constitute the opinion or endorsement of, or promotion by, the UPMC Center for Continuing Education in the Health Sciences, UPMC / University of Pittsburgh Medical Center or Affiliates and University of Pittsburgh School of Medicine. Reasonable efforts have been taken intending for educational subject matter to be presented in a balanced, unbiased fashion and in compliance with regulatory requirements. However, each program attendee must always use his/her own personal and professional judgment when considering further application of this information, particularly as it may relate to patient diagnostic or treatment decisions including, without limitation, FDA-approved uses and any off-label uses
No members of the planning committee, speakers, presenters, authors, content reviewers and/or anyone else in a position to control the content of this education activity have relevant financial relationships with any proprietary entity producing, marketing, re-selling, or distributing health care goods or services, used on, or consumed by, patients to disclose.
In support of improving patient care, the University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
The University of Pittsburgh School designates this live activity for a maximum of 11.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Other health care professionals will receive a certificate of attendance confirming the number of contact hours commensurate with the extent of participation in this activity.
- 11.50 AMA PRA Category 1 Credit™The University of Pittsburgh School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
- 11.50 Attendance