ACRP 2018 Meeting & Expo

Apr 27, 2018 ‐ Apr 30, 2018



Sessions

ACRP Certification Exam Prep: Part II

Apr 29, 2018 10:15am ‐ Apr 29, 2018 12:30pm

Identification: 211

Credits: None available.

Planning to earn your ACRP Certification?

The newly-revised ACRP Certification Exam Preparation Course provides eligible candidates guidance on how to prepare for the ACRP certification exams -- CCRA(R), CCRC(R) and CPI(R). Familiarize yourself with the exam format, gain valuable strategies for preparing for an ACRP exam, tackle sample exam questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP certification.

This session is part of a three-part series that will take place Saturday, April 28 and Sunday, April 29 from 10:15 am - 12:30 pm and Monday, April 30 from 8:15 - 10:30 am.

Note that CEUs will not be provided.

Speaker(s):
  • John Rowell, MSN, RN, CCRC, Director of Cancer Clinical Trials Office, LSU Health-Shreveport
Members: $25.00
Standard: $75.00

Effects of Recalls and Safety Alerts on Investigational Device Trials

Apr 29, 2018 10:15am ‐ Apr 29, 2018 12:30pm

Identification: 212

Credits: None available.

Explore the impacts of device recalls and safety alerts on clinical trials, and how proactive development of a risk management plan can help minimize confusion and negative consequences. Learn about Unexpected Adverse Device Effects reporting requirements to FDA, investigators, and IRBs. Understand the process of determining the need for a device recall and the steps involved in issuing a recall or safety alert. The speaker will discuss personal experiences and examples of device recalls, safety alerts, and the anticipated impact Unique Device Identification. Gain specific guidance on how to develop a plan for responding to implantable device recalls and alerts from a clinical trial management perspective. This session is a two-part "master series" program.

Learning Objectives:

  • Identify at least two potential impacts of a device recall or safety alert in a clinical trial
  • Develop impact assessment tools for their clinical trials when faced with a device recall or safety alert
  • List at least three components of a medical device recall / safety alert management plan, including UDI implications

Speaker(s):
Members: $25.00
Standard: $75.00

Privacy Regulations: Considerations Before, During, and After the Study

Apr 29, 2018 10:15am ‐ Apr 29, 2018 12:30pm

Identification: 213

Credits: None available.

Make sure you know HIPAA Privacy and Security Rules, and the implications of federal and state laws on privacy and information security, as they related to clinical research. The speaker will identify key challenges and common areas of non-compliance, and the different approaches Institutional Review Boards take to meeting regulatory obligations in this arena and their implications on the research team. Take away an understanding of why the structure of an organization – and the status of the researcher as it relates to the clinical component of the organization – can have implications for how compliance is achieved. This session is a two-part "master series" program.

Learning Objectives:

  • Understand the interplay between the Common Rule, the HIPAA privacy and security regulations and other regulations impacting clinical research
  • Identify key areas of concern and non-compliance regarding privacy and information security in a clinical research project
  • Work effectively with the compliance team of their organization to resolve privacy and information security concerns in research

Speaker(s):
  • Marti Arvin, JD, CHC-F, CCEP-F, CHPC, CHRC, VP Audit Strategy, Cynergistek
Members: $25.00
Standard: $75.00

Smart Monitoring: Is My Monitoring Adequate?

Apr 29, 2018 10:15am ‐ Apr 29, 2018 12:30pm

Identification: 214

Credits: None available.

Review the use of a standard system and tools to compliment the risk-based monitoring strategy. Speakers will pay special attention to effective source documentation review to assess if it meets ALCOA and the process for securing compliance. Learn about key verification points of consent, deviations, and safety while participating in practice exercises intended to identify, investigate, and resolve real-world site compliance issues. This session is a two-part "master series" program.

Learning Objectives:

  • Discuss monitoring and risk based indicators
  • Recognize the use of monitoring tools as part of the RBM strategy
  • Discuss the strategies of securing compliance for common issues identified

Speaker(s):
  • Jill Matzat, BSN, RN, CCRT, CCRA, President, Medical Research Management, Inc.
Members: $25.00
Standard: $75.00

Defining Quality in Clinical Trial Conduct and Preparing Investigators for Success: Findings from CTTI’s Investigator Qualification Project

Apr 29, 2018 11:30am ‐ Apr 29, 2018 12:30pm

Identification: 221

Credits: None available.

GCP training has become the industry standard for meeting sponsors' responsibility to ensure qualified investigators. Despite the widespread use of this training, little evidence has been collected to determine whether it provides the knowledge and skills necessary to support investigators and their delegates in the quality conduct of clinical trials. In addition, the burden of training that is redundant or of little value, often required before each clinical trial, could make it untenable for investigators to participate in future trials. Rather than accepting GCP training as the default solution for qualifying investigators, the Clinical Trials Transformation Initiative's multi-stakeholder project team has worked to gain a broader, evidence-based perspective to inform the efficient and effective qualification of site investigators for the quality conduct of clinical trials. Come learn about their findings.

Learning Objectives:

  • Describe the characteristics that define the quality conduct of clinical trials
  • Identify gaps and redundancies in the current training of investigators in preparation for the conduct of clinical trials
  • Discuss key learning objectives for training to qualify investigators for the quality conduct of clinical trials

Speaker(s):
Members: $25.00
Standard: $75.00

Investigator Compensation: Options and Tips for Sites

Apr 29, 2018 11:30am ‐ Apr 29, 2018 12:30pm

Identification: 222

Credits: None available.

Learn the different models by which investigators can be compensated, the basics of the Anti-Kickback Statute, the False Claims Act, the Stark Law, and how they govern investigator payment, and the average per-patient investigator compensation by trial type. Speakers will share one hospital’s experience successfully compensating physicians based on the various types of medical groups and hospital physicians they contract with. Take away tips for successful physician payment negotiations.

Learning Objectives:

  • Understand the laws that govern investigator payments
  • Explain different models for Investigator Compensation
  • Successfully negotiate physician payments with investigators

Speaker(s):
  • Suzanne Rose, MS, PhD, CCRC, Director, Office of Research, Stamford Hospital
Members: $25.00
Standard: $75.00

Tech-Driven Sites: The Why and How to Get There

Apr 29, 2018 11:30am ‐ Apr 29, 2018 12:30pm

Identification: 225

Credits: None available.

Gain a framework for identifying what research tasks to automate and how to prioritize them among different technology modules, and understand the key elements of an implementation plan. The speaker will discuss the wide and growing array of technology available to assist research sites with recruiting, financial administration, regulatory compliance, source data collection, lab routing, patient stipends, communications, business development, and more. Take away implementation tools such as a vendor qualification checklist, an ROI calculator, a compliance checklist, and a sample SOP, among others.

Learning Objectives:

  •  Identify what parts of your clinical trial operations to tech-enable
  • Prioritize your technology initiatives
  • Develop an implementation plan

Speaker(s):
Members: $25.00
Standard: $75.00

Diploma Mills and Phony Degrees: The Alarming Impact to Our Industry

Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm

Identification: 231

Credits: None available.

According to Wikipedia there are 400+ Diploma Mills in operation selling fake degrees and another 300+ websites offering counterfeit diplomas. The number of individuals "owning" a fake degree or diploma is hard to estimate, however Allen Ezel and John Bear boldly state in "Degree Mills: The Billion-Dollar industry that has Sold Over a Million Fake Diplomas" that more than 50% of the individuals claiming to have earned a PhD actually have a fake degree. There are not only legal ramifications for someone misrepresenting educational credentials, but the repercussions to the hiring company are just as serious. In this session, the speaker will provide resources to help identify Diploma Mills and Falsified Educational Credentials and discuss alternative solutions to the "Degree Requirement" in place at many companies.

Learning Objectives:

  • Describe the breadth and depth of the extensive issue of individuals representing Bogus Degrees
  • Use available resources to identify Diploma Mills and/or Falsified Educational Credentials
  • Understand the legal ramifications of misrepresenting educational credentials as well as the significant repercussions to Hiring Organization

Speaker(s):
Members: $25.00
Standard: $75.00

Preparing for Site Qualification Visits: Critical Steps

Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm

Identification: 232

Credits: None available.

Showcase your site in the most positive light by learning the critical steps in preparing for site qualification visits. The speaker will highlight methods for best presenting the knowledge and capabilities of your staff and facility, and for communicating effectively with CRO/sponsor personnel. Whether you need ground-up guidance on establishing infrastructure and preparing for a qualification visit, or you are looking to improve your existing processes and presentations, this session will provide the tools you need to ensure a positive site qualification visit.

Learning Objectives:

  • How to best prepare the investigational site/staff and ancillary facilities for the site qualification visit tour and staff/equipment assessment by the sponsor/CRO
  • Compile and provide the appropriate recruitment, site information and staff experience data to present to sponsor/CRO staff at the site qualification visit
  • Identify key investigational site staff to attend/conduct the site qualification visit with the sponsor/CRO

Speaker(s):
  • Elizabeth Weeks-Rowe, LVN, CCRA, Clinical Research Trainer/Writer, Clinical Research Writing and Training
Members: $25.00
Standard: $75.00

Compliance from the Inside: How My Husband's Untimely Death Taught Me the Real World of Compliance

Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm

Identification: 233

Credits: None available.

As a nurse and compliance professional, my recent experience dealing with my husband's sudden death brought home to me all that I work with every day. The reality of when it is "you" on the receiving end is overwhelming. I want to relate how understanding compliance from both sides helped me to give his organs and tissue for research. Grasping the state of affairs within hours and how compliance came over me was mind boggling. I hope to share my experience to help others who deal with patients every day

Learning Objectives:

  1. Verbalize the need for HIPAA
  2. Analyze a hospital's responsibility to a patient when they are an "employee"
  3. Create a culture that promotes research

Speaker(s):
  • Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager, Kelly Willenberg & Associates
Members: $25.00
Standard: $75.00