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ForwardOrientation to Research Fundamentals October 7-8
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: 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
Karen Schmidt, PhD
Director, Responsible Conduct of Research Center
Phone: 412-383-5808
E-mail: kschmidt@pitt.edu
Clinical and Translational Science Institute (CTSI)
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.
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
Karen Schmidt, PhD
Director, Responsible Conduct of Research Center
Phone: 412-383-5808
E-mail: kschmidt@pitt.edu
Clinical and Translational Science Institute (CTSI)