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Yes, Coursera provides financial aid to learners who cannot afford the fee. Apply for it by clicking on the Financial Aid link beneath the "Enroll" button on the left. Learn more. More questions? Visit the Learner Help Center. Design and Interpretation of Clinical Trials. Thumbs Up. Enroll for Free Starts Jan Offered By. About this Course 75, recent views.
Flexible deadlines. Shareable Certificate. Hours to complete. Available languages. Instructor rating. Lea T. Offered by. Johns Hopkins University The mission of The Johns Hopkins University is to educate its students and cultivate their capacity for life-long learning, to foster independent and original research, and to bring the benefits of discovery to the world.
Week 1. Video 5 videos. Welcome Video 3m. Lecture 1D: Adaptive Design 11m. Reading 3 readings. Welcome Message 10m. 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.
Training tips and remediation ideas along with a comprehensive dialogue on how to improve training will be presented. Session participants will be asked to share their viewpoints and experiences as to what they have seen and implemented at their study sites.
This session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. We will review the key steps of the process: risk identification, assessment, control, review, reporting, management, and communication. Having an effective risk management program not only ensures compliance with the ICH GCP E6 R2 requirements, but also ensures continuous improvement strategies for your clinical trials.
Practical take-aways will be shared along with sample tools. 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. 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.
Purpose: focuses on practical aspects of the preparation and execution of clinical study initiation; identifying and describing key activities, processes, and critical personnel. Methods: provides a practical overview of the significant processes in starting research at a site and a clear understanding of the main components of study initiation: document management, logistics, and people management.
Guidance, tools, and resources help the primary investigator and coordinator perform efficiently and understand how their responsibilities tie together with the tasks and duties of others. Conclusions: Organization and adequate time for the initiation process are critical to successful studies. Multiple activities must be orchestrated and performed concurrently, requiring use of study tools and efficient processes.
Identification and use of numerous research resources improve efficiency of study initiation and decrease work load and frustration. Since the publication and global implementation of ICH GCP E6 R2, Institutions and Investigators are grappling with the appropriate and adequate approaches for qualifying external parties e. The ICH E11 guideline changed the environment of drug development for the pediatric population.
The session will be beneficial for all clinical research professionals working in pediatric trials or those with an interest in the topic. We spend too much time in Clinical Research battling the technology that is supposed to be there to help us.
By utilizing available solutions that are designed to align current technologies across silos, 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.
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 centralize a hiring service.
There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting a clinical trial. These steps are crucial for every type of clinical trial. This session will describe how to apply those principles to investigator-initiated clinical trials utilizing tips, tools and templates available to help along the way. 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. This presentation will provide an overview of the key concepts a clinical research nurse or coordinator should know prior to independently managing their own clinical research project and how they should be incorporated into a clinical research training program. Identifying the right tactics to engage adult learners is often a trial and error process and this presentation will explore multiple methods to provide learners with the content they need to know and the pros and cons of each.
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.
Sites are busy and often overlook quality assurance QA and only focus on QA when issues arise or when faced with an audit. This presentation will describe our experience creating a culture of quality using an integrative approach in a team environment. Our techniques are easy to implement and include quality assurance checks, office guidelines, checklists and lessons learned. We will discuss the challenges of implementing a quality management system and how to overcome setbacks.
The three panelists before you have all faced this situation… and triumphed. In this session, learn how they did it. Expanded access to investigational drugs and devices has been available for decades through special pathways provided by the FDA.
More recently, two federal actions have widened this access. The previous rules governing expanded access have been modified to streamline the process to expedite such access. How do they differ?
This session will provide a current and complete description of the two pathways, their advantages and challenges. In clinical trials, studies are complex, time-intensive and leave little to no room for error. Particularly when conducting concurrent studies with limited resources, it can be difficult to ensure quality and timely data collection and entry on every study.
This can lead to stress and unhappiness with staff despite the meaningful work they contribute to improve treatment options. Clear and effective project management can make or break the success of a clinical trial, and project planning and management are a key part of achieving quality clinical data.
There are two vantage points to contracting and this session will allow the audience to hear from both regarding their processes and how they mirror and possibly conflict…. The number of data sources in clinical trials is increasing and the data coming from those sources are more complex than ever. What does that mean for the future of data handling and interpretation? It is a broad problem that touches many more areas than just traditional clinical data management.
This session will address how skill sets across multiple clinical research disciplines including bioinformatics, statistics, project management and clinical operations will need to broaden, and discuss why greater teamwork, cross-functional collaboration, and minimization of organizational silos are needed. 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. Site culture is a significant, yet under-addressed factor on the impact of timely and complete adverse event AE reporting; a large component of patient safety and execution of quality clinical trials.
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? 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. 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.
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.
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. Add to Cart. Introduction to Clinical Trials is an ideal program for all novice clinical researchers, those interested in the profession, or those indirectly involved in clinical trials. This two-hour online course details how medical products are developed, how volunteer patients are protected, and who plays key roles in the development, research, review, and approval of medical products.
In addition to supporting clinical research professionals and organizations, this program is an ideal tool for organizations seeking to help educate the public about clinical research and to raise awareness of clinical trials and the clinical research profession.
Apply by March 31, to earn your certification online, on-demand from February 15 to April 15, Understanding Clinical Trial Protocols. Building Quality Management Systems. Site Quality Management Tools. View More Free Courses. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases. Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners.
Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training. You will also stay up to date with any legislative changes in GCP as our training courses are constantly monitored, reviewed and updated.
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