Philadelphia University + Thomas Jefferson University

Clinical Research Fundamentals

Clinical Research Fundamentals is a full-day course, presented twice per year.

This course is designed to enhance understanding and improve performance of those involved in clinical research.  The course covers a broad variety of topics, providing a practical and solid foundation on the how-to’s and best practices of clinical research.

Click on the topics below to view the presentation slides:

Study Development & Design

Study Development and Design

Study Development and Design

Suzanne Adams, RN MPH
Director of Clinical Operations
Jefferson Clinical Research Institute (JCRI)

Roles & Responsibilities in Clinical Research

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Roles and Responsibilities in Clinical Research

Kathleen O'Malley, RN BSN CCRP
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)

Assessing Study Feasibility

Subject Screening, Recruitment, and Retention

Study Feasibility and Start-Up

Tiffany Morrison, MS CCRP
Director of Clinical Trials
Rothman Institute

Subject Screening, Recruitment, & Retention

Subject Screening, Recruitment, and Retention

Subject Screening, Recruitment, and Retention

Tiffany Morrison, MS CCRP
Director of Clinical Trials
Rothman Institute

Informed Consent Process

Informed Consent Process

Kathleen O'Malley, RN BSN CCRP
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)


Informed Consent Process: Federal Regulations / TJU Policies & Procedures

Informed Consent Process: Regulations / Policies

Patrick Herbison, MEd CIP
Research Compliance Manager
Office of Human Research (OHR)

Investigational Product Management / Accountability

IP Accountability in Outpatient Clinical Trials

Investigational Product Management / Accountability

Jessica Rinaldi, CCRP
Clinical Research Coordinator / Quality Assurance Specialist
Comprehensive Epilepsy Center

Data Management

Data Management: Regulatory Binder

Data Management: Regulatory Binder

Johanna Park, MS
JCRI Clinical Operations Team Lead, Regulatory
Jefferson Clinical Research Institute (JCRI)


Source Documentation, CRFs, and Electronic Records

Data Management: Source Docs, CRFs, and eCRFs

Thomas Salerno, RN BSN MA
JCRI Clinical Operations Senior Team Lead
Jefferson Clinical Research Institute (JCRI)

AE, UAP, & Protocol Deviations

Adverse Events, Unanticipated Problems, and Protocol Deviations

Adverse Events, Unanticipated Problems, and Protocol Deviations

Kathleen O'Malley, RN BSN CCRP
Manager of Education and Training
Jefferson Clinical Research Institute (JCRI)

Internal Audits

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Internal Audits

Patrick Herbison, MEd CIP
Research Compliance Manager
Office of Human Research (OHR)

FDA and Industry Sponsored Audits

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FDA Inspections and Sponsor Audits

Christine Jerome, BS CCRP
Director, Quality Assurance & Process Improvement Unit
Clinical Research Organization, SKCC

Clinical Trial Billing and Patient Remuneration

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Financial Considerations of a Clinical Trial

Jenny Campbell, MS MBA
Clinical Research Administrator
Jefferson Clinical Research Institute (JCRI)

Sponsor Visits and Monitoring

Sponsor Visits and Monitoring

Barbara Gallagher, RN
Senior Team Lead
Jefferson Clinical Research Institute (JCRI)


*Updated March 16th, 2017