Good Clinical Practices: Ensuring Quality in Clinical Trials

October 17, 2016

Marlo Thomas Center for Global Education and Collaboration
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105

Program Overview

Good Clinical Practices: Ensuring Quality in Clinical Trials will focus on implementation of good clinical practice regulations and guidance throughout the life of a clinical trial. Subject matter experts will speak on quality design of a clinical trial, quality data management, the revised ICH E6 guidance and its impact on study monitoring, maintaining regulatory documents and corrective action plans (CAPs). The agenda also includes breakout sessions on reporting SAEs, data coordinating centers and risks associated with patient/provider online communication. A special roundtable discussion is scheduled during the lunch break for those that are interested in moving into or advancing in a clinical research career.

Pre-registration is requested and is free.

Target Audience

These sessions will be appropriate for clinical staff involved in human research or interacting with human research volunteers. This conference would also be appropriate for legal and regulatory staff who advise researchers on conducting international research. The target audience includes physicians, psychologists, nurses, pharmacists, social workers, lawyers, regulatory staff as well as IRB committee members and other clinical research professionals.

Continuing Education Information

After attending this conference, you should be able to describe and implement the latest good clinical practice guidelines for protecting human research subjects and conducting quality clinical research.

Accreditation Statements

St. Jude Children’s Research Hospital is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

St. Jude Children’s Research Hospital is an approved provider of nursing continuing education by the Tennessee Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.

Credit Designation

St. Jude Children’s Research Hospital designates this live activity for a maximum of 7.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Attendees may receive a maximum of 6.56 contact hours in nursing continuing education. Nurses should claim credit commensurate with the extent of their participation in the activity.

SoCRA

The Society of Clinical Research Associates (SoCRA) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 7.0 hours of CE credit.

To claim credit for this activity, you must attend the sessions and complete the evaluation. The link to the evaluation will be distributed at the conference.

Directions

Enter St. Jude campus using the A.W. Willis Avenue Security Gate, which is marked “4” on your campus map. Once you have passed through the security gate, you will come to a four-way stop. At the four-way stop, the Marlo Thomas Global Education Center is directly across the street to your right. The best parking option is the parking garage, marked “Y” on the campus map. To enter, once you pass through the security gate, take a left at the stop sign and the parking garage entrance is directly on your left.

The Marlo Thomas Global Education Center is marked “IA” on the campus map. You will enter the Marlo Thomas Center through the main doors from Danny Thomas Place. There is a circular drive right in front of the main GEC entrance. There are sliding doors that you will enter. Upon entering, you will need a St. Jude employee to badge you in the building.

View Campus Map

Conference Schedule

All sessions take place in the Marlo Thomas Center for Global Education and Collaboration

Time/Place Event Hosts
7:30 a.m. - 8:15 a.m. Sign in
Late registration
Continental breakfast
 

8:15 a.m. - 8:30 a.m.

Auditorium

Welcome and Annoucements

Introduction

Janie Gardner, MS, CCRP, CIM

Victor Santana, MD
St. Jude Children's Research Hospital

8:30 a.m. - 9:25 a.m.

Auditorium

Building Quality into Clinical Trials (View Slides) Amy Hoeper, RN, MSN, CCRC
Cincinnati Children's Medical Center

9:30 a.m. - 10:25 a.m.

Auditorium

Quality Data Management (View Slides) Wenle Zhao, PHD
Medical University of South Carolina

10:30 a.m. - 11:25 a.m.

Auditorium

Updates to ICH E6: What it Means for Monitoring Clinical Trials (View Slides) Efim Kelman, MD, MBA
Confidence Pharmaceutical Research
11:30 a.m. Lunch (on your own)  

11:45 a.m. - 12:50 p.m.

Board Room

So! You Want to Go Into Clinical Research? Dayton Rinehart, MBA, CCRP, and
Jennifer Larkin, MS, CCRP (facilitators)
St. Jude Children's Research Hospital

1:00 p.m. - 2:00 p.m.

Board Room

Breakout Session: Serious Adverse Event Reporting (View Slides) Victor Santana, MD
St. Jude Children's Research Hospital

1:00 p.m. - 2:00 p.m.

Lecture Hall

Breakout Session: Text Me, Facebook Me, Email Me, PM Me, Snap Me or Tweet Me - Just Don't Expose Me (View slides) Lynette Larkins, MBA, PMP
St. Jude Children's Research Hospital

1:00 p.m. - 2:00 p.m.

Auditorium

Breakout Session: Data Coordinating Centers: Enhancing Quality of Multicenter Trial (View slides) Dixie Ecklund, RN, MSN, MBA
University of Iowa

2:00 p.m. - 3:00 p.m.

Auditorium

Documenting the Story of a Clinical Trial: Concept to CAPA (View slides) Lori Gilmartin, RN
Gilmartin Consulting, LLC

3:00 p.m. - 3:30 p.m.

Auditorium

Q&A Speaker panel