ACRP 2017 Meeting & Expo

Apr 28, 2017 ‐ May 2, 2017


The Association of Clinical Research Professionals (ACRP) Meeting & Expo is the largest annual clinical research education and networking event solely focused on the conduct of clinical trials. The conference provides clinical research professionals with more than 75 educational sessions addressing more than a dozen topics critical to the clinical research process.

Packages Display Packages

Sessions Included:

eSource as the Next Wave of Technology (Apr 29, 2017 09:50 AM)

The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance (Apr 29, 2017 09:50 AM)

Medical Cannabis: A Substitute for Prescription Opioid Use? (Apr 29, 2017 09:50 AM)

Master Series Program, Part I — The ICH GCP E6 R2 Revisions: Impact On The PI And Site (Apr 29, 2017 02:30 PM)

Master Series Program, Part II — The ICH GCP E6 R2 Revisions: : Impact On The PI And Site! (Apr 29, 2017 03:45 PM)

Breaches in Research Integrity: Maintaining the Public's Trust and Confidence (Apr 30, 2017 09:50 AM)

Regulatory Affairs Committee: 2016 Year-End Review and Looking Ahead (Apr 30, 2017 09:50 AM)

Forging a New Path to Professionalism: GCP vs. Core Competency-based Training (Apr 30, 2017 02:30 PM)

Evidence-based Analysis: The Path to Exceptional Clinical Research (Apr 30, 2017 03:45 PM)

The Science of Site Management: Using Metrics to Guide Decisions (Apr 30, 2017 03:45 PM)

Beyond Audit Survival: The Busy Clinical Research Professional's Guide To Audit Preparation (May 01, 2017 08:30 AM)

Phage Therapy: The Answer to Antibiotic Resistence? (May 01, 2017 08:30 AM)

CDER BIMO Compliance and Enforcement: What You Need to Know! (May 01, 2017 09:45 AM)

2017 Update: U.S. Healthcare Regulatory Changes and Their Impact on Clinical Research (May 01, 2017 02:30 PM)

Lead and Succeed in Your Clinical Research Team (May 01, 2017 03:45 PM)

The Power and Reach of Social Media in Clinical Trials (May 02, 2017 08:30 AM)

Revitalizing a Workforce: Aligning Job Classifications with Competencies (May 02, 2017 08:30 AM)

Obtaining Consent in Acute Settings (May 02, 2017 09:45 AM)

Fine-tuning Your Vulnerability Radar (May 02, 2017 08:30 AM)

Returning Research Test Results: Know Your Ethical and Legal Obligations (May 02, 2017 11:00 AM)

Standard: $215.00
Members: $115.00

Sessions

Signature Series Session -- A Conversation with the FDA

Apr 29, 2017 8:15am ‐ Apr 29, 2017 9:30am

Identification: 1-1

Credits: None available.

ACRP kicks off its 2017 Meeting & Expo with A Conversation with the FDA. Join us to hear directly from representatives of the U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER), Offfice of Scientific Investigations (OSI) and Office of Study Integrity and Surveillance (OSIS) about the latest agency initiatives, including the bioresearch monitoring (BIMO) program, current clinical research regulations and recently published guidance documents. Bring your questions!

This panel presentation is the first in a series of sessions in which you'll be able to interact directly with FDA representatives throughout the conference. Besides educational sessions, this year features FDA Office Hours, a special, one-to-one Q&A opportunity for attendees to bring their questions to the FDA during the weekend Expo hours.

Learning Objectives:

  1. Discuss FDA compliance and enforcement programs with CDER, OSI and OSIS
  2. Develop program alignment strategies for BIMO inspections
  3. Review current and newly-published guidance and regulations related to clinical investigations of drug products

Speaker(s):
  • David Burrow, Pharm.D., J.D., Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA
Speaker(s):
  • Jan Hewett, B.S.N., J.D., Regulatory Counsel (Policy), Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA
  • Sean Kassim, Ph.D., Director, Office of Integrity and Surveillance, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA
  • Douglas Pham, Pharm.D., J.D.
Standard: $75.00
Members: $25.00

Mastering Your Response to the Dreaded FDA Form 483

Apr 29, 2017 9:50am ‐ Apr 29, 2017 10:50am

Identification: 2-3

Credits: None available.

Each year, roughly 250 FDA Bioresearch Monitoring Program (BIMO) inspections of clinical investigators result in the issuance of an FDA Form 483 with findings. Having received notice of an objectionable condition at your site, it's now up to you to respond adequately. Failure to do so can escalate the FDA's concern to a warning letter, which can have devastating consequences for an investigational site. The key to avoiding a warning letter is a timely and robust response to the initial 483 that outlines a corrective action plan and sets forth its implementation expeditiously. Learn about BIMO, common Form 483 findings and themes, and optimal responses to the notice.

Learning Objectives:

  1. Discuss the purpose and background of the FDA’s BIMO inspections and resulting Form 483 report
  2. Criticallly review and evaluate Form 483 reports to extrapolate common themes
  3. Design optimal responses to Form 483 reports, including robust corrective action

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

The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance

Apr 29, 2017 9:50am ‐ Apr 29, 2017 10:50am

Identification: 2-4

Credits: None available.

This session takes a practical approach to risk-based monitoring. Clinical monitors, project managers and risk managers learn how to maximize their monitoring resources to have the greatest impact on quality and compliance. Learn about the shift in the monitoring paradigm from the quality-control (QC) approach of checking each data point against a source to more of a quality-assurance (QA) approach that focuses on the systems and processes that generate and report the data. Add the QA methods of interviewing and root-cause assessment to your monitoring toolbox as an effective means of determining the areas in which monitoring resources can have the greatest impact. Discuss real findings from a well-established audit program in a risk-based monitoring environment and auditor suggestions to help you avoid common mistakes.

Learning Objectives:

  1. Discuss the evolving role of the clinical monitor in the new era of RBM and demonstrate how CRAs and project managers must modify their approach to clinical monitoring when taking a risk-based approach
  2. Contrast system-based monitoring to source data verification-focused monitoring
  3. Discuss common audit findings from RBM and how they can be applied

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

Effective Communication Strategies to Drive Program Success

Apr 29, 2017 9:50am ‐ Apr 29, 2017 10:50am

Identification: 2-1

Credits: None available.

What constitutes good communication in the clinical research industry? Are your communications with stakeholders within the clinical research arena contributing to successful program and project outcomes, or just creating new challenges for you? Join us to examine examples of good and poor communications, and the implications and costs of poor communication across various clinical and operational areas.

Learning Objectives:

  1. Improve communications on a day-to-day basis
  2. Identify obstacles that lead to poor communication and negative results
  3. Practice good communication skills

Speaker(s):
  • Louis Grue, RN, BS, BSN, CCRA, CPM III, Leidos Biomedical
  • Katharine Garrett, CCRA, Clinical Research Associate, Garrett Monitoring Services
Standard: $75.00
Members: $25.00

U.S.-based IRBs vs. European and Latin American Ethics Committees

Apr 29, 2017 9:50am ‐ Apr 29, 2017 10:50am

Identification: 2-5

Credits: None available.

How do European and Latin-American Ethics Committees operate and how are they different from a U.S.-based IRB? Join us to explore how ethics committees approach site performance and compliance; reviews; and the application of standards-based processes to promote and facilitate professionalism, performance, safety and compliance in clinical trials. Gain insight into how to anticipate and deal with the possible challenges of dealing with an ethics committee and learn how to apply your newfound knowledge to your current role.

Learning Objectives:

  1. Explain the way ethics committees in Europe and Latin America operate
  2. Identify the differences between European, Latin American and U.S. ethics committees
  3. Apply the new knowledge in their current trials

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

Medical Cannabis: A Substitute for Prescription Opioid Use?

Apr 29, 2017 9:50am ‐ Apr 29, 2017 10:50am

Identification: 16-3

Credits: None available.

The abuse of prescription opioids has reached epidemic proportions in the United States and Canada and is cited as the most common cause for overdose deaths. Given these alarming findings, there is an urgent need to identify alternative treatments for chronic pain. This session explores the therapeutic effects of medical cannabis as an alternative option for chronic pain patients. Research methods and results examine the challenges associated with patient use, access to medical cannabis and the implications of medical cannabis as a substitution.

Learning Objectives:

  1. Discuss case studies and the results of research studies examining the use of medical cannabis as a substitute for opioids
  2. Examine the issues surrounding opioid use, challenges associated with patient access to medical cannabis, and the role of medical cannabis for chronic pain patients
  3. Evaluate the implications of medical cannabis as a substitution for prescription opioids

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

eSource as the Next Wave of Technology

Apr 29, 2017 9:50am ‐ Apr 29, 2017 10:50am

Identification: 2-2

Credits: None available.

Have you ever wondered why, in 2017, clinical research sites are still collecting data in paper binders? eSource has been on the horizon for years, but has been slow to take off. This session examines performance data and the convergence of trends that suggest eSource is the next major wave of technology in clinical research. Join us to review what the hard data tells us and what eSource means to you. Valuable to sponsors and sites alike, this session outlines the benefits of eSource and identifies recent FDA initiatives in this area.

Learning Objectives:

  1. Identify the benefits and trends related to eSource
  2. Discuss eSource research findings related to Operational efficiency
  3. Outline key considerations for exploring eSource for your site

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

Signature Series Session -- When the Physician Becomes the Patient: The Inspiring Story of Dr. Keith Eaton

Apr 29, 2017 11:05am ‐ Apr 29, 2017 12:05pm

Identification: 3-1

Credits: None available.

From physician to trial subject and back...that is the journey of Dr. Keith D. Eaton, a medical oncologist at the University of Washington / Seattle Cancer Care Alliance. In November 2012, after experiencing fatigue and chest pain, Dr. Eaton had a sinking feeling he had leukemia. After diagnostic tests confirmed his suspicions and he was given less than a 5% chance of survival, Dr. Eaton went through multiple rounds of chemotherapy before receiving CAR T-Cell therapy, which reduced his cancer to undetectable levels. He subsequently underwent a stem cell transplant and has since returned to a healthy life.

Today, Dr. Eaton continues to be an active clinical investigator and the PI of more than 20 industry-sponsored, investigator-initiated and NIH-funded trials. His inspiring survival story offers rare insight into clinical trials from both the researcher and subject perspectives.

Speaker(s):
  • Keith Eaton, M.D., Ph.D., Associate Professor, University of Washington/Seattle Cancer Care Alliance
Standard: $75.00
Members: $25.00

eConsent: Preparing for Paperless Consent

Apr 29, 2017 2:30pm ‐ Apr 29, 2017 3:30pm

Identification: 4-1

Credits: None available.

Join site, industry and IRB experts to discuss the variety of eConsent products becoming available and how eConsent tools can be used for in-office and remote consenting. By some estimates, the paper-based informed consent process will be replaced by eConsent systems within five years. How prepared are you for the implementation of eConsent, including planning for HIPAA compliance, special consent situations and the archiving of eConsent records? Do you know what information sites and sponsors should submit to an IRB when proposing to use an eConsent tool? Join us to get answers to these questions (and many more) and receive a practical checklist for assessing your research site's readiness to use eConsent tools.

Learning Objectives:

  1. Describe how a variety of eConsent tools can be used effectively in the informed consent process
  2. Identify the topics a research site should address in its SOPs on the use of eConsent, including managing a hybrid paper and eConsent process, special consent situations, HIPAA compliance and archiving eConsent records
  3. Describe to the site's IRB how an eConsent tool will be used in a manner consistent with the Common Rule and other regulatory requirements

Speaker(s): Speaker(s):
  • Jessica Huening, Regulatory Attorney, Kinetiq, a div of Quorum Review IRB
  • Philip Coran, JD, CISA, CIPP/US, Sr. Director Quality and Regulatory Affairs, Medidata Solutions
  • Linda Coleman, JD, CIP, CHC, CHRC, CCEP-I, Director, Human Research Protection Program, Yale University
Standard: $75.00
Members: $25.00

Making Business Intelligence the Cornerstone of Your Study Improvement Process

Apr 29, 2017 2:30pm ‐ Apr 29, 2017 3:30pm

Identification: 4-2

Credits: None available.

Learn how to incorporate Key Performance Indicators (KPIs) and metrics to improve your studies. These powerful, data-driven tools drive effective communication, team alignment and collaboration, and process improvement. Within the context of clinical research, dashboards and reports that include study-specific metrics and KPIs help you define and deliver goals and performance information to all members of the study management process in collaborative and actionable ways. This presentation illustrates the power of these business intelligence concepts using basic techniques and visualizations, and reviews the basic information technology elements that may be required to implement these tools.

Learning Objectives:

  1. Discuss the use and application of metrics in a clinical research management environment
  2. Summarize how to develop basic metrics and KPIs
  3. Describe tips for data visualization and delivery to your team

Speaker(s):
  • Janice Kyle, Data Warehouse/Business Intelligence Analyst, University of Utah Department of Pediatrics
  • Melissa Metheney, BS, RN, CCRC, Program Director, Department of Pediatrics, University of Utah
Standard: $75.00
Members: $25.00
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