Event Calendar

Advanced Management

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2018 Agenda

2019 Agenda Coming Soon! 

Saturday, September 29, 8:30 to 9:15    

Optimizing Investigational Pharmacy Operations in Support of Clinical Trials 

Dr. Parr will provide a review of workflows leading to efficient and safe processing of investigational drug orders; strategies to establish synergy between research coordinators, study teams, and pharmacy; and establishing productive pharmacy-sponsor relationships. 717

Presenter: Douglas Parr, PharmD,  Clinical Pharmacist Lead, Darmouth-Hitchcock Medical Center 

Track: Advanced Management

Saturday, September 29, 9:20 to 10:05                                    

Investigator Responsibilities - Explaining FDA's  Guidance Document 

Investigator responsibilities (21 CFR 312.60) are some of the most important obligations in a clinical trial. The FDA’s guidance document will be reviewed and expanded with examples of what study related tasks can be delegated, what constitutes adequate training, what constitutes adequate supervision, and responsibilities for oversight of the study team. This is done in the name of protecting the rights, safety, and welfare of the study subjects. 719

Presenter: Harvey Arbit, PharmD, MBA, CCRP, RAC, President, Arbit Consulting, LLC

Track: Advanced Management

Saturday, September 29, 10:50 to 11:35                                  

Single and Central IRB Review - Helpful Hints for Coordinators 

What information does a single or central IRB need to conduct its review? How can the study materials accurately capture the information for an IRB committee?  How can teams operationalize single IRB review for study coordination?  Ms. Abel will address single and central IRB review in terms of what a study coordinator needs to know to submit and manage a study for single or central IRB review. 721

Presenter: Rebecca Abel, MA, CIP, Regulatory Manager, Vanderbilt Ingram Cancer Center 

Track: Advanced Management

Saturday, September 29, 11:40 to 12:25                                  

Human Centered Design in Clinical Trial Operations: Setting Your Team Up for Success 

Solutions to challenges in clinical research operations must be business viable, technology feasible, and humanly desirable to create real and lasting impact. Using Human-Centered Design (HCD) in clinical trial operations engages the team at the heart of operations to come up with a range of solutions to the challenges they face each day. Sponsors, CROs and sites already use HCD to recruit and retain subjects in their trials by researching population characteristics to inform trial design and marketing campaigns and fully informed consent to be sure subjects are engaged and understand how to participate successfully in the trial. Using HCD in clinical operations would increase job-ownership and satisfaction, decrease turn-over and training costs, decrease start-up and enrollment periods, and decrease team performance redundancies. This could change the tide for many clinical trial organizations. The people who face the operational challenges hold the key to the answer. 723

Presenter: Heather Baldwin, MPH, CPCM, Principal Consultant, Frogbottom Consulting, LLC. 

Track: Advanced Management

Saturday, September 29, 1:40 to 2:25          

Fraud, Waste, and Abuse in Clinical Research and the False Claims Act 

The federal and state False Claims Acts (or Whistleblower Acts) play an important role in detecting fraud, waste and abuse. A person who “knows” of fraud, waste, or abuse being committed against the government can file a lawsuit on behalf of the government and, in some cases, receive a reward for bringing original information about a violation to the government’s attention. Because of the importance of the False Claims Acts in clinical research, this presentation will provide a primer on the False Claims Acts, address fraud enforcement trends and the various “hot button” issues in clinical research. The presentation will also discuss how non-compliance compromises not only the financial and operational viability of current trials, but may result in (1) a loss of funding, (2) a risk of fines and penalties imposed by oversight agencies, (3) settlement costs and/or damages arising from actions, and (4) diminution of the organization’s reputation.  725

Presenter:  Shauna Itri, JD, MA, BS, Attorney/Shareholder, Berger & Montague PC

Track: Advanced Management

Saturday, September 29, 2:30 to 3:15    

Improved Site Management Through the Lens of Training and Education

This presentation will describe the role of education and training to improve site management and overcome barriers to clinical research at an urban academic medical center. Ms. O’Malley will present methods to improve compliance, support clinical research personnel in their roles, and increase retention of effective clinical research staff. There will be a discussion of tips and tools to define processes, improve access to required systems, and optimize online resources. 727

Presenter: Kathleen O'Malley, BSN, RN, CCRP, CCE,  Manager of Education and Training, Jefferson Clinical Research Institute, Thomas Jefferson University  

Track: Advanced Management