Orientation to Research Fundamentals (ORF) May 10-12, 2022

May 10, 2022 to May 12, 2022

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.

https://cce.upmc.com/content/orientation-research-fundamentals-orf-may-10-12-2022


 

 

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: 
  • 12.75 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.
  • 12.75 ANCC
    UPMC Provider Unit is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation
  • 12.75 Attendance
Course opens: 
05/10/2022
Course expires: 
06/30/2022
Event starts: 
05/10/2022 - 8:15am EDT
Event ends: 
05/12/2022 - 1:00pm EDT
Rating: 
0

 

Day 1: Tuesday, May 10, 2022 Time

Title

Speaker

8:15

Welcome & Introduction

Teri Reiche

8:20

01 Role of a Research Coordinator

Sue Clifton & Katelyn Collinger

8:35

02 Clinical & Translational Science Institute

Sue Clifton

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

10:20

06 Recruitment Sources

Katelyn Collinger & Sue Clifton

10:35

07 Pitt + Me: How to Use it

Kerri Jackson

10:50

08 Community Engagement & Trust

RaNaja Kennedy, Libby Powers & Leah McKown

11:05

09 Diversity & Inclusion in the Clinical Research Workforce

Bee Schindler

11:35

BREAK

11:45

10 Standard Operating Procedures (SOPs)

Shannon Valenti

12:00

11 Study Documentation

April Lehman

12:50

12 Costs & Billing in Clinical Trials

Laurie Rudzinski

1:10

Wrap Up

Teri Reiche

Day 2: Wednesday, May 11, 2022 Time

Title

Speaker

8:15

Welcome

Teri Reiche

8:20

13 Informed Consent Process

Maggie Soncini

9:15

14 Working with the Human Research Protection Division (IRB)

Melissa Miklos

9:55

BREAK

10:05

14 Working with the Human Research Protection Division (IRB) – Part 2

Melissa Miklos

10:35

15 Office of Sponsored Programs (Office of Research)

Kristy Rizzo

11:10

16 Devices, Drugs, & Biologics

Nita Missig-Carroll

11:55 BREAK

12:05

17 Safety Issues

Jean Barone

12:50

18 Investigational Drug Service

Jennifer Kozar

1:00

Wrap Up

Teri Reiche

Day 3: Thursday, May 12, 2022 Time

Title

Speaker

8:15

Welcome

Teri Reiche

8:20

19 Social, Behavioral & Educational Research (SBER) Studies

Dana DiVirgilio

9:15

20 Import/Export of Biological Agents & Dangerous Goods Shipping

Rebecca Lingenfelter

9:30

21 Audits & Inspections

Kelly Dornin-Koss

10:05

22 Introduction to Clinical Trials Billing Compliance

Melissa Travis & Joe Bickus

10:45 BREAK

10:55

23 Human Gene Transfer & IBC Review

Beverly Harding

11:10

24 Vincent Payment Solutions

Carrie Showman

11:35

25 COI Management & the Responsible Conduct of Research

Jane Volk

12:10

26 Research Using eRecord Data & the Health Record Research Request (R3) team

Jonathan Silverstein

12:25

Wrap Up

Teri Reiche

 

Teri Reiche
Sue Clifton
Katelyn Collinger
Kelly Dornin-Koss
Judy Navratil
Kerri Jackson
RaNaja Kennedy
Libby Powers
Leah McKown
Bee Schindler
Shannon Valenti
April Lehman
Laurie Rudzinski
Maggie Soncini
Melissa Miklos
Kristy Rizzo
Nita Missig-Carroll
Jean Barone
Jennifer Kozar
Dana DiVirgilio
Rebecca Lingenfelter
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 is a stockholder of Westlabs Analytics, Inc.

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 12.75 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 12.75 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

  • 12.75 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.
  • 12.75 ANCC
    UPMC Provider Unit is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation
  • 12.75 Attendance
Please login or register to take this course.

Please only claim credits for the day or days you attended the event.

Calculate in 15 minute increments: 15 minutes = .25, 30 minutes = .50, 45 minutes = .75, 1 hour = 1.0

Day 1: Tuesday, October 19, 2021

Time 4.0 CME

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 4.25 CME

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 4.0 CME

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