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ForwardOrientation to Research Fundamentals (ORF) May 10-12, 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.
Additional Information
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 ANCCUPMC 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 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