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AE collecting, documenting and reporting seems straightforward process that can be covered with a standard operating procedure. In reality, the process itself is impacted by the site culture and effective communication among all of the employees at the site. Quality sites also have a culture that recognizes that clinical trials and their participants are complex, thus requiring checks and balances between the team. This presentation will define the negative impact of strained site cultures on adverse event reporting, identify internal and external pressures, and strategies for improving culture, communication, and adverse event reporting.

The use of a project management tool, a Work Breakdown Structure WBS to define clinical trial start-up tasks, timelines, and assignments is an effective method to improve project success. Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. This session will provide information on the implications and consequences of investigator and staff misconduct in clinical research. Using case studies and actual findings, participants will learn about clinical trials compliance, what kinds of misconduct have occurred in the past and the consequences of a finding of misconduct.

Reasons for committing fraud will be explored. A career in clinical research as a CRO professional has many advantages — plentiful demand, good compensation, and the ability to make a positive impact — but investigating and exploring these career opportunities can be difficult for those unfamiliar with contract research organizations. The presentation will include real world examples including those who start their professional careers at a CRO, those who transition from other jobs and industries, some common career paths, and some not so common ones. Taking the time to do this by the CRC and CRA would make the best use of our limited time together promoting a quality and timely work product.

We have often heard from CRCs that they look to CRAs as their first point of Sponsor contact, a guide and support, not just a someone to verify data against source documents. How can we maximize our roles to effectively reach our individual goals while supporting each other?

An mHealth solution for Clinical Trials

It will also highlight ethical and privacy concerns, reviewing recent big data consent guidelines and how to clinically integrate RWD. This session shows best practices from a clinical setting that has multiple RWE publications. The way regulated processes, documents and work practices are handled and executed offer opportunities on a daily basis. This session will shine the spotlight on the site monitoring visit report and provide guidance to CRAs on how to not only document observations at the site but also to communicate key information to the trial team in an effective manner.

This talk will present 7 behaviors that CPMs can internalize and demonstrate to prevent firefighting.

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The discussion will also include real-world examples and tried-and-true techniques that will help avoid some of the pitfalls, along with the hefty benefits garnered when the behaviors are embraced. Skip Burris will present some of the challenges in Oncology research and some of the innovative solutions that he and his team at Sarah Cannon Research Institute have implemented to overcome these challenges. This session will also provide a review of current metrics associated with the Bioresearch Monitoring BIMO program, including common regulatory violations.

Finally, recently released guidance documents and regulations changes related to good clinical practice will be discussed. Kristin Smedley is proof that a change in perception can drive one person to impact an entire field. Eighteen years ago Kristin was on course to achieve her dream: Teacher of the Year.

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However, fate had an unanticipated outcome for her destiny. Her two sons were diagnosed soon after birth with a rare blindness. Although Kristin was initially paralyzed with fear, she launched an extraordinary mission to change their bleak future. Kristin will demonstrate how the power of perceptions and expectations drives your outcomes and discuss components necessary to ignite your own extraordinary journey through her often hilarious real life stories and examples. Ten years ago, the medical device regulatory landscape was perceived to have limited options for bringing new therapies and devices to patients in a timely manner.

Today, however, that outlook has changed due in part to the significant efforts that FDA has taken to advance medical device innovation and safety by focusing on our vision. This presentation will provide an overview of multiple CDRH initiatives across the total product lifecycle ranging from streamlined regulatory approaches for clinical studies to new programs for expediting review of devices which address unmet medical needs, and increased opportunity for using real world evidence to support regulatory submissions.

Duke invested in a new clinical research management system CRMS to improve quality and support reworked business processes that create administrative simplicity and operational excellence. The CRMS is the central tool to track the clinical research operations portfolio. Its integration with the electronic IRB system a match on protocols, including exemptions is critical to understanding the diverse clinical research activities across the institution.

This required Duke to: implement system-wide workflows, create pathways for heavy and infrequent users, and develop tools for monitoring non-compliance and data completeness. The CRMS has been integral in helping study teams use standardize workflows. Technology is changing at light speed and the automobile, retail, airline, finance and many other industries have made a concerted effort to adapt to such.

Types of Study Designs

The pharmaceutical industry has been a lager in adapting to newer technologies and clinical trial processes have evolved very little in two decades. However, the regulatory authorities are embracing an effort to transform clinical trials and change is now inevitable for sponsors, CROs, clinical sites and patients. All clinical research professionals will want to attend this session to assess your readiness and how you may want to prepare.

Maintaining the confidentiality, integrity and availability of data and systems is critical in healthcare. A cyber-security incident could result in the compromise of critical information or systems, disruption of operations, and even harm to patients. For these reasons, multiple layers of security defenses are needed to protect our people, data, devices, systems, and networks. People in all roles need to understand the critical part they play and how to utilize processes and technology to protect our ecosystem. Join FDA personnel from the Center for Drug Evaluation and Research as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one.

The speaker will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to s after an inspection, and responding to subsequent regulatory correspondence. The session will help you create an analysis of where you may need to focus your studies.

A discussion of the exam format and valuable strategies for exam preparation will be discussed. Looking to find new ways to organize and increase your workload without becoming overwhelmed? This session will break down how you can better understand your strengths and utilize them to improve productivity.

We will cover how this can be applied in the patient setting to provide the best care for your patients before, during and after the visit. We will also cover how you can use these skills to improve communication and data deadlines with sponsors. Lastly, this session will cover tips and examples where organization and multitasking can improve the amount of work being completed. In this session, the rationale for surgical placebo-controlled trials will be reviewed.

Network Groups and Their Support Components

One example of such a trial is the world first randomized placebo-controlled trial to evaluate the efficacy and cost-effectiveness of decompressive surgery for lumbar spinal stenosis, which is currently being conducted in Australia. A variety of techniques have been used to address ethical and safety considerations including the unusual step of recruiting a consumer and ethicist to act in advisory roles to provide input on the practicalities of the study design.

This session will provide attendees with a high level overview of the trial together with highlighting key learnings about protocol design, consent form drafting and collection of consent, recruitment of surgeons, working with private healthcare providers, and other relevant site level activities. It has been a big year for gene therapy. In the past 12 months, three gene therapy products received approval from FDA.

The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. In this presentation, Dr. Social Media has been a new highly innovative and disruptive technology to many industries, but most importantly clinical trials. Our latest talk on social media breaks down, step-by-step, the latest techniques for patient recruitment, retention and advocacy across the new and old platforms including: Snapchat, Instagram and Facebook.


This presentation is for a new coordinator or for coordinators who would like a refresher. The presentation will address the creation of comprehensive source documents and how to incorporate source documents within the electronic medical record system without creating more work.

IPPCR 2016: Data Management & Case Report Form Development in Clinical Trials

Source documentation is critical for obtaining accurate data. The number one cause of FDA s reported is that sites are not following the protocol.

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  • Therefore, developing well written source documents will provide detailed instructions on the information that must be collected. The presentation will also discuss utilizing the electronic case report form manual to identify additional data points to include in their documentation.

    Source documents should be organized in such a way that anyone is able to complete a visit without missing essential data points. After defining these terms, we will review parameters that most commonly define the scope of a project from both a sponsor, CRO, and site perspective. The importance of tracking scope changes and monitoring for scope creep will be shown using examples of how these could impact on studies. This session will describe three important steps to assure RC competency in study procedures at the beginning of a trial: risk assessment, development of a competency based training program, and implementation of that program.

    Participants will gain an understanding of how to conduct a risk assessment for a clinical trial. They will also learn how to develop and implement this type of program for their studies in order to help increase study procedure awareness and CRC competence. Take-aways will include a training checklist template that can be applied to clinical trial study start-up and a toolkit describing our program. A lot has happened this year!

    How are recent legal and regulatory changes fundamentally affecting research? What should research sites and institutions be ready for in the coming months and years? Site activation cycle times within the industry are now worse than they were over a decade ago by an average of 4 to 6 weeks.

    This session will provide practical information on how technologies, best practices, and KPIs can proactively lead life-science organizations towards an entirely different approach to managing study startup. This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences.