Good Research Practices 4.22.2020

April 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.

 

 

Target Audience

THIS ACTIVITY IS INTENDED FOR PROVIDERS IN THE SPECIALTIES OF:

Addiction Medicine

Cardiology

Critical Care (Intensivists)

Dermatology

Endocrinology

Gastroenterology

Geriatric Medicine

Gynecological/Oncology

Hematology/Oncology

Infectious Disease

Neurology

Pediatric Medicine

Peripheral Vascular Disease

Physical Medicine and Rehabilitation

Preventive Medicine

Psychiatry

Pulmonary Disease

Rheumatology

Sleep Medicine

Sports Medicine

Unknown Physician Specialty

 

Learning Objectives

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Learning objective is to provide an overview of Good Clinical Practice as they relate to:  

The Federal Regulations & NIH Policy

Protocol Adherence

PI Responsibilities

Informed Consent

Study Documentation

Course summary
Available credit: 
  • 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
Course opens: 
08/15/2019
Course expires: 
06/30/2020
Event starts: 
04/22/2020 - 1:00pm
Event ends: 
04/22/2020 - 3:45pm

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

 

Agenda

*Introduction and Review of RCCO and Federal Regulations

*Review of Tips for Protocol Adherence

*Review of PI Responsibilities

*Informed Consent Process

*Study Documentation

*Questions

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
PA
United States

Kelly Dornin-Koss, MPPM, RN, CIP, 

Faculty Disclosure

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.

Physician (CME)

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.

 

 

Available Credit

  • 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
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