Orientation to Research Fundamentals (ORF) - CTSI 6.2-4.21

June 2, 2021 to June 4, 2021

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.

Course summary
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
Course opens: 
06/01/2021
Course expires: 
12/30/2021
Event starts: 
06/02/2021 - 8:15am
Event ends: 
06/04/2021 - 1:30pm

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

 

University of Pittsburgh Biomedical Science Tower Room #120
PA
United States

Karen Schmidt, PhD
Director, Responsible Conduct of Research Center
Phone: 412-383-5808
E-mail: kschmidt@pitt.edu

Clinical and Translational Science Institute (CTSI)

www.RCR.pitt.edu

 

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. 

 

Melissa Miklos

 

 

 

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
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Karen Schmidt, PhD
Director, Responsible Conduct of Research Center
Phone: 412-383-5808
E-mail: kschmidt@pitt.edu

Clinical and Translational Science Institute (CTSI)

www.RCR.pitt.edu