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ForwardOrientation to Research Fundamentals (ORF) - CTSI 6.2-4.21
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.
Target Audience
Research Coordinators
Learning Objectives
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.
Day 1: Wednesday, June 2, 2021
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
9:55 BREAK
10:05 05 Recruitment & Retention Judy Navratil
10:30 06 Study Documentation April Lehman
11:20 BREAK
11:30 07 Diversity and Inclusion in the Clinical Research Workforce Mario Browne
11:45 08 Standard Operating Procedures (SOPs) Shannon Valenti
12:00 09 Costs and Billing in Clinical Trials Laurie Rudzinski
12:20 10 Office of Sponsored Programs (Office of Research) Kristy Rizzo
12:55 Wrap Up Teri Reiche
Day 2:
Thursday, June 3, 2021
8:15 Welcome Teri Reiche
8:20 11 Informed Consent Process Maggie Soncini
9:15 12 Working with the Human Research Protection Office (IRB) Melissa Miklos
9:50 BREAK
10:00 12 Working with the Human Research Protection Office (IRB) – Part 2 Melissa Miklos
10:30 13 Audits and Inspections Kelly Dornin-Koss
11:05 14 Devices, Drugs, and Biologics Nita Missig-Carroll
11:50 BREAK
12:00 15 Safety Issues Allison Gerger
1:00 16 Research Using eRecord Data & the Health Record Research Request (R3) team Jonathan Silverstein
1:15 Wrap Up Teri Reiche
Day 3:
Friday, June 4, 2021 Time Title Speaker
8:15 Welcome Teri Reiche
8:20 17 Pitt + Me: How to Use it Kerri Jackson
8:35 18 Pitt + Me: Marketing your Study Heather Rockwell
8:50 19 Social, Behavioral and Educational Research (SBER) Studies Dana DiVirgilio
9:35 20 Import/Export of Biological Agents & Dangerous Goods Shipping Rebecca Lingenfelter
9:50 21 Introduction to Clinical Trials Billing Compliance Melissa Travis & Joe Bickus
10:15 BREAK
10:25 22 Investigational Drug Service Jennifer Kozar
11:10 23 Human Gene Transfer & IBC Review Beverly Harding
11:25 24 Vincent Payment Solutions Carrie Showman
11:50 25 COI Management and the Responsible Conduct of Research Jane Volk
12:25 Wrap Up Teri Reiche
Disclaimer Statement
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
Karen Schmidt, PhD
Director, Responsible Conduct of Research Center
Phone: 412-383-5808
E-mail: kschmidt@pitt.edu
Clinical and Translational Science Institute (CTSI)
Teri Reiche
Sue Clifton & Katelyn Collinger
Dana Farrell
Kelly Dornin-Koss
Judy Navratil
April Lehman
Mario Browne
Shannon Valenti
Laurie Rudzinski
Kristy Rizzo
Maggie Soncini
Melissa Miklos
Nita Missig-Carroll
Allison Gerger
Dr. Jonathan Silverstein
Kerri Jackson
Heather Rockwell
Dana DiVirgilio
Rebecca Lingenfelter
Melissa Travis
Joe Bickus
Jennifer Kozar
Beverly Harding
Carrie Showman
Jane Volk
The following relevant financial relationships were disclosed:
Jonathan Silverstein, MD, MS, FACS, FACMI receives Grant/Research support from Pfizer
No other planners, 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 to disclose.
Accreditation and credit designation
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.
Physician (CME)
The University of Pittsburgh School designates this live activity for a maximum of 13.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nursing (CNE)
The maximum number of hours awarded for this Continuing Nursing Education activity is 13.0 contact hours.
Other Healthcare Professionals
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.
Available Credit
- 13.00 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.
- 13.00 Attendance
Karen Schmidt, PhD
Director, Responsible Conduct of Research Center
Phone: 412-383-5808
E-mail: kschmidt@pitt.edu
Clinical and Translational Science Institute (CTSI)