Dr. 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. He will share some best practices and resources that can be utilized by other institutions and most of all he will share his key takeaway in clinical research that you won’t want to miss.
While GCP Quality Assurance (QA) in clinical research settings is not an FDA regulatory requirement, the FDA, research sites and industry are trending towards implementing quality assurance programs. The ICH E6(R2) guideline also raises expectations for QA and conveys the expectation that GCP auditing will be performed. Do you know what you need to know about quality assurance auditing? Implementing a GCP QA program closes the loop between quality control (QC) and quality management. Learn how QC and QA compliment each other. Together they allow for greater assurance of GCP compliance and that data being presented within a regulatory submission will be accurate and defensible. We will introduce GCP auditing, review the FDA’s CPGM for Investigators, Sponsors and IRBs, and relevant sections of the ICH E6(2) Guideline.
A lot has happened this year! Get up to speed with this overview session designed to bring you the highlights and breaking news since last year's ACRP Conference. 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? Get answers to these questions and more through this session's issue-spotting exploration and analysis of changes in laws, regulations, and standards promulgated by FDA, DHHS, the NIH, and ICH.
Detailed and accurate documentation, source or otherwise, is crucial in clinical research and yet the site monitoring visit report is often perceived as a "B-list" celebrity when compared with the superstar, source documentation. 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.
Successful clinical trial projects don’t happen, they require effective planning and processes at both the site and sponsor/CRO to meet timelines. 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. Instruction on how to implement a WBS for clinical trial start-up planning will be mapped out along with best practices to ensure successful communication between the investigative site departments responsible for timely deliverables to the sponsor/CRO.
The ICH E11 guideline changed the environment of drug development for the pediatric population. In this session the speaker will provide a basic overview of pediatric clinical research to include the specifics written in the ICH E11 guideline and the rationale for the revision based on the FDA’s input. The session will be beneficial for all clinical research professionals working in pediatric trials or those with an interest in the topic.
Regulatory and Legal Changes, the Common Rule, and GDPR: How They Can Impact Study Data Flow Based on Real and Perceived Changes to the Privacy of Information
The session will allow the audience to identify and anticipate compliance issues associated with the privacy concerns around the revised Common Rule. It will help the audience understand the reasons why institutions may require steps to help ensure privacy that will no longer be legally required by the revised Common Rule but may be required by research institutions because of ethical concerns. It will also provide the audience with information on the privacy concerns to anticipate when research involves or could involve data covered by the GDPR.
Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective
This session will provide an overview on how to appropriately identify, document, and address compliance issues noted at sites, from monitoring and Sponsor perspectives. There will be an overview of common monitor findings and a discussion about appropriate next steps for developing effective CAPAs. The escalation of issues to the Sponsor will be discussed along with how to adequately document compliance issues in monitoring reports and follow-up letters. Possible ways in which the Sponsor can handle noncompliances will be addressed, as well as the consequences and risks to the Sponsor and study if compliance issues are not addressed. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.
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. Source documentation is critical for obtaining accurate data. The number one cause of FDA 483s reported is that sites are not following the protocol. 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.
Companies are faced with challenges to make medical devices safe for human use. Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. In this interactive session, participants will look at a five step approach to risk management. Attendees will gain knowledge into the identification, assessment, evaluation, reduction, control and monitoring of risk that are essential to device risk management. Speakers will provide tools, guidance, and some tips on developing a risk management strategy.
We are participants in the development process, impacting the lives of patients and improving the human condition. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life-cycle. When they come to review the processes, paper and people involved we must be ready. This visit is expected with known methods so why is there so much angst for an inspection? Taking a team approach, identify the strengths of your resources and aligning those to an inspection "game plan" brings confidence to any inspection team.
Michelleanne Bradley, Consultant & President, Metis Consulting Services
This session will focus on an overview of the Office of Regulatory Affairs “Program Alignment” initiative including new divisions, what the initiative will mean for your next (or first) inspection, and who to contact with concerns. 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.
While most of us intuitively understand the concept of scope, many do not firmly understand how project managers use the terms "scope", "scope creep", and "scope change". 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.
Clinical research program management is highly complex and requires coordination, communication and cooperation among multiple stakeholders, departments, and teams. Improving research management workflows is a priority for research programs. Reviewing organizational capabilities and streamlining multiple systems and workflows throughout the research program infrastructure expedites performance. Transforming research management infrastructure, processes, and technology enables efficiencies, and is key to improving cycle times and reducing redundancies. Identifying and effectively communicating with key stakeholders fosters champions for change and eliminates roadblocks for implementation success. Participants in this Master Session will learn practical, step-by-step transformational strategies and tools, and have the opportunity for hands-on practice using these tools through case studies.
Join Kenneth A. Getz, MBA, Director of Sponsored Research Programs & Research Associate Professor, Tufts Center for the Study of Drug Development, as he examines the forces shaping the current and future state of the clinical research industry. Explore the individual dynamics of technology, process, and workforce on the industry and their effect on each other.
It has been a big year for gene therapy. In the past 12 months, three gene therapy products received approval from FDA. In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. In this presentation, Dr. Vaughn will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for clinical development of new gene therapy products.
This presentation will focus on selecting the best vendors for a specific study, including vendor costs in the study budget, and how to successfully collaborate with the vendors from startup to close out. (This session will not cover qualification of vendors.) The speaker will review the most common types of vendors needed for clinical research studies, what information each type will request from the study sponsor, and how to develop vendor budgets. There will be a discussion on how to review vendor proposals to determine the best fit for the study. Once selected, the speaker will review methods to ensure oversight of the vendor during the length of the study.
It is critical to manage the performance on a project through key operational indicator metrics. Those metrics measure the current operational and financial health of the project that allow the project team to ensure the project deliverables based on the contract and statement of work are met. In this session attendees will learn, through this ongoing review process using key operational indicators, how to proactively identify risks and develop specific and actionable plans. The project manager is able to share this data with the Sponsor to ensure clear visibility and accountability on the project. The goal is to achieve flawless execution on a project by managing to the scope of work and providing quality deliverables within the required timeline.
This session is brought to you by a generous educational grant, courtesy of Kelly Services.
The clinical research landscape is complicated and increasingly burdensome to clinician scientists. To better handle the evolution of the research, the role of the clinical research professional has become even more important; employing a top-notch clinical research workforce is critical. In this session attendees will learn how an AMC prioritized the role of the workforce by using the competency-based framework developed by the Joint Taskforce for Clinical Trial Competency (JTF), to implement many initiatives. These institution-wide strategic initiatives include 1) overhaul job classifications, 2) create advancement through a tiering process, 3) establish a professionals network, 4) align competencies with on-boarding and training, 5) create pipelines for clinical research positions, and 6)centralize a hiring service.
This one-hour session will consist of eight, 5-minute presentations, on hot topics in the clinical research industry. The sessions will be designed to differentiate between myth and fact, guidance on hot topics and fun inspirational stories.
• Good Cleaning Practices: A Dishwasher's Allegory to Quality in Research presented by David Vulcano
This is a humorous allegory to site quality using an allegory we can all relate to, washing dishes. Many aspects of both good site performance and excellent dishwashing are surprisingly similar...as are the headaches.
• Communicate with Savvy presented by Dalfoni Banerjee
It’s widely believed that communication is a key to project success. However, do we consider that even when we are doing a stellar job, if we aren’t communicating with key stakeholders in ways that resonate with them, all our excellent work and successes are almost for naught? We’ll discuss 12 quick tips for communicating with savvy that will bolster project success.
• Knocking Down the Silos presented by Stephanie Abbott
We spend too much time in Clinical Research battling the technology that is supposed to be there to help us. That’s time taken away from caring for the patient. In order for technology to be effective it needs to be designed to transcend the silos, breaking down the barriers that keep Investigators and staff away from doing what they do best, supporting patients on clinical trials. There are a number of technology options available to sites, but few of them seem to understand research workflow and patient interaction from the site perspective. It doesn’t have to be an “either-or”, it can be an “and”. Sites can support their patients and still not be shackled by the technology involved.
• From Project Manager to Project Implementation Specialist presented by Romiya Barry
Implementation science is said to be the future of clinical research. Project managers possess a unique skill set to help shepherd new therapeutics from concept to clinical practice. Implementation Science theories, models, and frameworks can extend the utility of the Project Management Life Cycle Framework in planning, engaging, executing, evaluating, and reflecting on clinical project implementation.
• Sex vs Gender: Demonstrating Respect for Participants Through Inclusive Questioning presented by Katie Dry
In adherence to FDA expectation, the percentage of male and female participants in clinical research trials is reported ubiquitously across publications. Yet male and female outcomes continue to be presented interchangeably under definitively different variables: sex/gender. Since demographic information often involves self-report, exclusive and discriminatory intake forms, even if unintentional, can have significant consequences, not just on data accuracy, but on the patient’s perception of the care in to which he or she is entering. Acknowledging that patient-centered care is an emerging focus of clinical trial professionals, this rapid-fire session will emphasize the key differences between sex and gender and explore, from the patient’s perspective, the immediate need to collect these demographics accurately and inclusively. The session will also highlight how competent introductory interactions with patients have the potential to improve recruitment, safety, retention and outcomes.
• 'Certify'ably Confused: Certifying Source Documentation presented by Gina Remington
FDA's regulations related to investigator record keeping and record retention (21 CFR 312.62) are quite general. Twenty-first century research also imposes a shift from a paper to a paperless system, further contributing to the confusion around the concept of certifiable copies of research records. The ICH guidance related to use of certified copies usually applies to circumstances whereby original records are duplicated to a different form of media for archiving purposes and the originals are destroyed (ICH, 2018). However, if a certified copy substitute for the original is warranted, an SOP to describe how such copies would be made verified and documented is helpful, decreasing time spent by the research coordinator with the CRA during routine monitor visits. This presentation will summarize the current definition of “certified copy” and offer an example of SOP language to address workflow, compliance, and efficiency in research coordination.
• A Father's Inspiration on Public Speaking presented by David Vulcano
This quick session will share a fun story regarding my father's coaching of my speech for an elementary school contest... and how it pivoted my life (and presentations) forever.
Sponsors, CROs, and Investigator sites are all too aware of the stress of preparing for a health authority inspection. The challenge is that most organizations begin preparing for an inspection when a drug is filed for approval or they receive notification of an inspection. The key to a successful inspection is preparing at the start of the study. Ensuring that your Investigator Site File (ISF) and Trial Master File (TMF) are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings.
One of the biggest challenges to implementing change in an organization is employee resistance to change. This session introduces participants to the challenges and obstacles that resistance poses and presents research-based change management practices to mitigate resistance to change. A real-world case study will be used to demonstrate the principles and will be followed throughout the session. Through structured and guided exercises and small group discussion, participants will have the opportunity to apply the learning to a change they are experiencing in their own organization.
This session is brought to you by a generous educational grant, courtesy of Veeva Systems.
We spend too much time in Clinical Research battling the technology that is supposed to be there to help us. That’s time taken away from caring for the patient. By utilizing available solutions that are designed to align current technologies across siloes, we can ease the burden on the research staff, so that Investigators and staff can get back to the disciplines that drew them to the healing arts in the first place. This session will address the technology options available to sites, and participants should walk away empowered, knowing that it’s not an “either-or”, but an “and”; that they can support the patient and still not be shackled by the technology involved.
Gene therapy studies are becoming increasingly common as the US FDA and other countries have begun issuing approvals for gene therapies, particularly in the field of oncology. Gene therapy studies pose exciting advancements for clinical research but also involve additional risks and regulatory requirements. Gene therapy studies receiving federal funds or taking place at sites receiving federal funds, require review by both an IRB and an Institutional Biosafety Committee prior to registering with the National Institutes of Health (NIH). Further review may be required by the NIH Recombinant DNA Advisory Committee (RAC). This presentation will summarize the current state of gene therapy research and the associated risks. Attendees will learn how to obtain the necessary regulatory approvals and prepare sites to conduct gene therapy research.
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.
Maintaining the confidentiality, integrity, and availability of data and systems is critical in healthcare. A cybersecurity 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.
CDRH’s vision is that patients in the US have access to high quality, safe and effective medical devices of public health importance first in the world. 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.
What would happen if you transformed your view on change? What if you learned how to master positive change and lead others through the process? The impact of this transformation will surprise you. Your ability to embrace and engage in meaningful change will extend into all areas of life. The Reality of Change Leadership will become a catalyst for positive change in your organization and beyond.
Featuring Dr. Fred Johnson, CEO & Founder of InitiativeOne
Dr. Fred Johnson is the Chief Executive Officer and Founder of InitiativeOne.
He has created and implemented Leadership Transformation processes that accelerate positive culture change by helping leaders become more authentic, courageous, open, and human than ever before.
This powerful shift in mindset allows teams to lead change through aligned and focused decision making and problem solving.
Dr. Johnson has worked with Fortune 500 companies, professional and collegiate sports teams, as well as school districts and universities across the country.
He is passionate about elevating leaders and exponentially impacting the leadership culture of an organization.
Book Signing Immediately Following!
Dr. Johnson will be available following his ‘Signature Series’ session for a meet-and-greet and book signing.
His book, The Reality of Change: Mastering Positive Change is Key to Extraordinary Leadership and Optimal Business Outcomes, will be available to purchase at ACRP 2019, but you can order advance copies today from Amazon in both hardback and digital versions.