Good Research Practices 4.22.2020
Overseeing a research study can be challenging, especially if you are new to the research environment. This workshop will provide an overview of the various components of Good Research Practices. Topics to be discussed include: Federal Regulations Governing Human Subject Research, Tips for Protocol Adherence, Investigator Responsibilities, Informed Consent, Study Documentation, and Regulatory File Maintenance. This program is strongly encouraged for new investigators and coordinators as they start their clinical research careers as well as those with research experience.
THIS ACTIVITY IS INTENDED FOR PROVIDERS IN THE SPECIALTIES OF:
Critical Care (Intensivists)
Peripheral Vascular Disease
Physical Medicine and Rehabilitation
Unknown Physician Specialty
Learning objective is to provide an overview of Good Clinical Practice as they relate to:
The Federal Regulations & NIH Policy
Kelly Dornin-Koss, MPPM, RN Introduction and review of NIH GCP policy 10 minutes
Deb Montrose, PhD PI Responsibilities 20 minutes
Melissa Miklos, MSL Protocol development and working with PittPRO and the IRB 45 minutes
BREAK 10 minutes
Maggie Soncini, BS Informed consent document and process 45 minutes
BREAK 10 minutes
Kelly Dornin-Koss, MPPM, RN Study Documentation Requirements and Reportable New Information 40 Minutes
*Introduction and Review of RCCO and Federal Regulations
*Review of Tips for Protocol Adherence
*Review of PI Responsibilities
*Informed Consent Process
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
Kelly Dornin-Koss, MPPM, RN, 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.
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.
The University of Pittsburgh School designates this blended activity for a maximum of 2.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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.
- 2.75 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.
- 2.75 Attendance