Orientation to Research Fundamentals (ORF) October 19-21, 2021

October 19, 2021 to October 21, 2021

The CTSI Orientation to Research Fundamentals Program is an intensive, three-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

Nurse

Physician

 

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: 
  • 12.25 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.
  • 12.25 ANCC
    UPMC Provider Unit is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation
  • 12.25 Attendance
Course opens: 
10/14/2021
Course expires: 
12/30/2021
Event starts: 
10/19/2021 - 8:15am EDT
Event ends: 
10/21/2021 - 1:00pm EDT
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Day 1: Tuesday, October 19, 2021

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

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: Wednesday, October 20, 2021

Time Title Speaker

8:15 Welcome Teri Reiche

8:20 11 Informed Consent Process Maggie Soncini

9:15 12 Working with the Human Research Protection Division (IRB) Melissa Miklos

9:50 BREAK

10:00) 12 Working with the Human Research Protection Division (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 Wrap Up Teri Reiche

 

Day 3: Thursday, October 21, 2021

 

Time Title Speaker

8:15 Welcome Teri Reiche

8:20 16 Pitt + Me Kerri Jackson

8:50 17 Social, Behavioral and Educational Research (SBER) Studies Dana DiVirgilio

9:45 18 Import/Export of Biological Agents & Dangerous Goods Shipping Rebecca Lingenfelter

10:00 19 Investigational Drug Service Jennifer Kozar

10:10 BREAK

10:20 20 Introduction to Clinical Trials Billing Compliance Melissa Travis & Joe Bickus

11:00 21 Human Gene Transfer & IBC Review Beverly Harding

11:15 22 Vincent Payment Solutions Carrie Showman

11:40 23 COI Management and the Responsible Conduct of Research Jane Volk

12:15 24 Research Using eRecord Data & the Health Record Research Request (R3) team Jonathan Silverstein

12:30 Wrap Up Teri Reiche

Katelyn Collinger

 Dana Farrell

 Teri Reiche

 Kelly Dornin-Koss

Judy Navratil

April Lehman

 Mario Browne

Shannon Valenti 

Laurie Rudzinski

Kristy Rizzo

Maggie Soncini

Melissa Miklos

Kelly Dornin-Koss

Nita Missig-Carroll

Allison Gerger

Kerri Jackson

Dana DiVirgilio

Rebecca Lingenfelter

Jennifer Kozar

Melissa Travis & Joe Bickus

Beverly Harding

Carrie Showman

Jane Volk

Jonathan Silverstein

 

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 12.25 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 12.25 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

  • 12.25 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.
  • 12.25 ANCC
    UPMC Provider Unit is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation
  • 12.25 Attendance
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