Orientation to Research Fundamentals

October 7, 2019 to October 8, 2019

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: 
  • 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
Course opens: 
09/02/2019
Course expires: 
06/30/2020
Event starts: 
10/07/2019 - 8:00am
Event ends: 
10/08/2019 - 7:40pm

Day 1: October 7, 2019

Time

Title

Speaker

8:15

Welcome and Introduction

Karen Schmidt

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 Research Process

Karen Schmidt

9:15

04 Developmental Landmarks, Regulations, & Good Clinical Practice

Kelly Dornin-Koss

9:55

BREAK

 

10:10

05 Recruitment & Retention

Judy Navratil

10:35

06 Study Documentation

Cindy Kern

11:25

07 Standard Operating Procedures (SOPs)

Shannon Valenti

11:40

LUNCH

 

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

Paula Davis

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

Karen Schmidt

 

 

 

Day 2: October 8, 2019

Time

Title

Speaker

8:15

Welcome

Karen Schmidt

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

Phil Gomez

9:50

BREAK

 

10:05

16 Office of Sponsored Programs (Office of Research)

Nathan Bray

10:40

17 COI Management and the Responsible Conduct of Research

Brendan Linton

11:15

18 Audits and Inspections

Kelly Dornin-Koss

11:50

LUNCH

 

12:30

19 OSPARS Introduction and Overview

Katah Shields

12:45

20 Creating a Compliant Clinical Trials Billing Plan

Melissa Travis

1:10

21 Investigational Drug Service (breakout session)

Alan Yee

1:10

22 Devices, Drugs, and Biologics (breakout session)

Nita Missig-Carroll

1:10

23 Social, Behavioral and Educational Research (SBER) Studies (breakout session)

Dana DiVirgilio

1:55

BREAK

 

2:05

24 Vincent Payment Solutions

George Cerminara

2:30

25 Human Gene Transfer & IBC Review

Beverly Harding

2:45

26 Costs and Billing in Clinical Trials

Laurie Rudzinski

3:05

Wrap Up

 

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

 

Karen L. Schmidt, PhD

Nathan Bray, JD

Kelly Dornin-Koss, MPPM, RN, CCRC

Beverly Harding, MSL

Cindy Kern, RN, CCRC, CIP

Melissa Miklos, MSL, CIP

Nita Missig-Carroll, RN, BSN, OCN, CCRC

Judith Navratil, MA, CIP

Heather Theoret Rockwell, MPW

Laurie Rudzinski

Katah Shields, BA

Maggie Soncini, BS, BSN

George Cerminara

Sue Clifton MEd

Katelyn Collinger, MA

Paula K. Davis, MA, CDE

Dana J. Farrell,

Phillip Gomez

Kerri Jackson

Jennifer Kozar, PharmD

Rebecca Lingenfelter, MSPH  

Brendan A. Linton, BA

Joseph Madia, MD

Dana DiVirgilio, MSP, CIP

Melissa Travis, RN, BSN, MSL

Shannon Valenti, MBA, CIP

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.

Melissa Miklos

 

 

 

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 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.

 

Available Credit

  • 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

Accreditation Period

Course opens: 
09/02/2019
Course expires: 
06/30/2020
Please login or register to take this course.

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