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About the June 2013 Issue

It’s all in how you look at it; just as a prism reveals many colors in a single beam of light, putting yourself in someone else’s shoes metaphorically challenges us to consider previously unnoticed aspects to another person’s viewpoint. The “Vantage Point” theme for this issue illuminates different perspectives on common areas of research that you may already know well. The hope is that you will read the articles herein with an open mind and, for only a moment, try on someone else’s shoes.

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Free Lead Article

Benefits of Working with a Central IRB: Improved Efficiencies and Enhanced Human Subject Protections
Stephanie Pyle, MFA
As timelines and budgets continue to shrink, while the pressure to generate meaningful clinical data continues to grow, the clinical research industry increasingly turns to experienced central institutional review boards (IRBs) with expert reviewers to perform knowledgeable reviews in a timely manner. This article examines how utilizing a central IRB creates significant efficiencies throughout the review process and improves the safety of human subjects participating in research.

JOINT MESSAGE
The Best of Both Worlds: How and Why ACRP and APCR are Restructuring
Gary A. Shangold, MD, FACOG, CPI, Chair, ACRP Board of Trustees
Christopher P. Allen, MD, FRCA, FFPM, President, APCR Board of Trustees

GUEST EDITOR’S MESSAGE
Vantage Point: The Research Side of Wearing Someone Else’s Shoes
Amy Leigh Davis, DBA, MBA, CCRC

PEER REVIEWED ARTICLES
Vantage Point
Benefits of Working with a Central IRB: Improved Efficiencies and Enhanced Human Subject Protections
Stephanie Pyle, MFA
As timelines and budgets continue to shrink, while the pressure to generate meaningful clinical data continues to grow, the clinical research industry increasingly turns to experienced central institutional review boards (IRBs) with expert reviewers to perform knowledgeable reviews in a timely manner. This article examines how utilizing a central IRB creates significant efficiencies throughout the review process and improves the safety of human subjects participating in research.

Vantage Point: Maintaining a Local IRB
Julia Kennedy, MPA, CIP
Some institutions struggle with the decision over whether to maintain a local institutional review board (IRB) or to outsource review to an external review board. Unfortunately, there are limited measurable data on IRBs or comparisons of different IRB review models in terms of cost, efficiency, and subject protections. Concerns about outsourcing reviews include lack of local knowledge, quality of review, potential legal liability, fear of federal disciplinary action, and lack of federal guidance. The following discussion presents the perspective of an institution that chooses to maintain a local IRB.

Is Risk-Based Monitoring a Risky Business? Industry Perspectives and Considerations for Implementation
Nikki Christison | Karen L. Gilbert, CCRA
Since the 2011 Food and Drug Administration draft “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” came out, multiple questions about the implementation of reduced and/or remote monitoring have come to light. Traditionally, we have source verified 100% of data during onsite monitoring visits, but how much risk is involved in changing this practice? By developing risk analysis algorithms, focusing on the use of technology, and emphasizing communication and escalation pathways, we can help address industry fears in modifying practices and the risks of individual studies. We can then determine the ideal approach to the monitoring of each study. Through an industry-based survey and case study analysis, this article addresses industry concerns and approaches to further adoption of the risk-based monitoring approach.

Clinical and Translational Research: The Expanding Role of Community Providers
Lori A. Nesbitt, PharmD, MBA
Healthcare advances depend on innovation through implementation and execution of scientifically valid research. However, research and development is not enough to guarantee new and improved therapies in the future. To ensure that research continues, investment is needed by both private and public entities.  However, advances in medicine also depend on policies and processes that encourage research and meaningful collaborations by and between academic medical centers and community healthcare providers. Given the logistical, political, and operational challenges in shifting from a provider culture to a research culture, this manuscript highlights organizational opportunities and risks of meaningful participation in clinical and translational research. In addition, it provides recommendations regarding infrastructure requirements for a robust research enterprise and organizational influences for successful community and academic partnerships.

OPINION
The Affordable Care Act and Patient Recruitment: Impact or Impasse?
Carmen R. Gonzalez, JD
The Affordable Care Act (ACA) seeks to provide insurance coverage to millions of Americans as each of its provisions is activated over the next few years. However, its impact on clinical trial patient recruitment is uncertain. This essay reviews what aspects of the ACA are implicated in patient recruitment, while recognizing the vagaries of the various budgetary and political movements that are still afoot and may yet influence the clinical research enterprise for good or ill in the years ahead.

Other Issues in Clinical Research
Considerations for Designing Metrics to Enhance Clinical Research: A Site’s Perspective
Kimberly Bazylewicz, CCRC | Donna F. Brassil, RN, MA, CURN, CCRC | Rhonda G. Kost, MD
Metrics are measures of an organization's performance. The development of metrics involves identifying the values of an institution, determining the goals that express those values, and developing measures to assess meeting these goals. The process also includes planning for systematic capture and regular analysis of the data. Metrics may identify activities that contribute to or detract from achieving desirable outcomes. The development of metrics should incorporate the expectation that performance improvement activities will follow the analyses. This article describes elements to consider when developing metrics to measure outcomes that can make a difference in conducting clinical research.

Subject Recruitment: Are You Prepared to Succeed?
Mark Metzner, BA | Charles H. Pierce, MD, CPI
Recruitment is a process by which populations of patients (volunteers) with prescribed characteristics (as defined in the study protocol) are sought and enrolled into a clinical trial. Recruitment always takes longer than initially anticipated unless you have planned well. As goes the success of a clinical pharmacology unit’s recruiting, so goes the success of the unit overall. This article outlines the keys to successful recruitment and, very importantly, to successful retention of the volunteers in a site’s database.

Source Documents, Flow Sheets, Duplicates, and Discrepancies
Yanwen Xia, PhD, CCRP
This article addresses two kinds of source documents: primary and secondary sources. A primary source is defined as information taken from direct interactions with patients or from clinical research coordinator (CRC) research flow. Secondary sources encompass anything transcribed or copied from primary sources. This article argues that the existence of secondary sources in medical records often causes confusion, data discrepancies, and unnecessary work for monitors and CRCs. Therefore, it advocates the limitation of secondary sources in medical charts. It also suggests monitors focus on primary sources, and use secondary sources only when the primary source is not available. Throughout the article, examples are taken from clinical research in an oncology setting.

COLUMNS

CAREERS—PASSING IT ON
An Interview with Steven Steinbrueck, MPH, CCRA
Beth D. Harper, MBA

CRC PERSPECTIVES
Sharing the Unique Perspectives of CRCs
Claudia G. Christy, RN, MSN, CCRC | Laura B. Cowan, MA

DATA-TECH CONNECT
Social Media: Why it Cannot be Ignored and Other Burdens of Modern Data
Kirk Mousley, MSEE, PhD

DEMYSTIFYING DEVICES
Center for Devices and Radiological Health (CDRH) Online Resources
Ellen Pinnow, MS | Sheila Brown, MS, RN

OFF THE WIRE
New Perspectives on Research Challenges
Gary W. Cramer

OPERATING ASSUMPTIONS
The Chrysalis Fallacy
Ronald S. Waife

RESEARCH COMPLIANCE
Orphan Drugs and Humanitarian Use Devices
Brent A. Ibata, PhD, JD, MPH, RAC, CCRC

ASSOCIATION NEWS

ACRP 2013 GLOBAL CONFERENCE & EXHIBITION WRAPUP
Warming Up to the Subjects
The 2013 ACRP Annual Awards
The 2013 APCR Annual Awards
Certification Milestone Recognition Ceremony
Even as Conference Loomed, New Initiatives Sprang to Life

CHAPTERS
ACRP Chapter Listing
Chapter Notes

APCR NEWS
APCR Board of Trustees & Organizational Listing
APCR PRESIDENT’S MESSAGE (See Joint Message on page 5)

DEPARTMENTS
Home Study: Vantage Point
ACRP Board of Trustees, Committees, and Staff
ACRP/APCR Uniform Code of Ethics and Professional Conduct
Monitor Article Submission Guidelines
Index of Advertisers
Calendar of Events