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Webinars

August | September |

August

August 4, 2015

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

12:00 PM - 3:00 PM Eastern

The Clinical Research Associate (CRA) creates reports that have many audiences, one being regulatory authorities reviewing essential documentation of clinical trials linked to marketing application approvals. This web seminar presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, Memos to File, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective, and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.

August 4, 2015

Barnett International

CRA Current Practice Update: Impact of the FDA BIMO Program

1:00 PM - 3:00 PM Eastern

The FDA announced in 2006 an initiative to modernize the regulation of clinical trials, including the BIMO inspections program. This includes conducting inspections and other assessments earlier in the development of a potential product to build quality into the clinical trial upfront rather than assessing it at trial completion. From this initiative, the FDA has generated new guidance and regulation that directly affect the performance of the sponsor monitor. The initiative is a dynamic process and this web seminar tracks the updates that directly affect monitoring. Examples of how to implement the agency requirements and recommendations into current practices and specific projects are also covered.

August 5, 2015

Barnett International

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

12:00 PM - 2:00 PM Eastern

The Trial Master File (TMF) is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations as sponsor for a clinical trial project. This web seminar reviews the sponsor TMF required and additional content for a clinical trial. The activities of set-up, maintenance, and quality control and assurance will be discussed along with common deficiencies and challenges. This course will also include handouts and discussion of the TMF Reference Model.

August 10, 2015

Barnett International

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

9:30 AM - 11:00 AM Eastern

Strategies for saving time and money, without compromising oversight and quality, are an ongoing challenge within the industry. In an age where technology is ever present from ordering medications online, consulting with a physician, and having “live” conversations in chat rooms about medical issues, the clinical research industry has been slow to maximize the use of technology. With sponsors/CROs implementing the FDA’s final guidance on a risk-based approach to monitoring, time on site is being reduced to one day visits and/or on-site visits are scheduled few and far between per monitoring plans. Better utilization of remote monitoring is critical to ensure sites are compliant and the data is accurate and consistent. During this web seminar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what “red flags” to look for that may indicate issues on site.

August 10, 2015

Barnett International

Implications of the FDA Guidance for a Risk-Based Approach to Monitoring

12:00 PM - 1:30 PM Eastern

The FDA’s Guidance for the Monitoring of Clinical Investigations (1988-2010) has been removed from the FDA list of guidance documents. Instead, the FDA has released an updated version of the Bioresearch Monitoring (BIMO) Compliance Program Guidance Manual for Sponsor/CRO and Monitoring. In August 2013, the agency issued a final guidance to reflect their expectations and recommendations related to monitoring investigation sites, monitoring systems, and investigative site oversight. In this web seminar, the content and the implications to sponsor monitoring and clinical investigation sites will be discussed.

August 11, 2015

Barnett International

CRO Selection Criteria, Evaluation, and Establishing the Relationship

1:00 PM - 2:30 PM Eastern

Outsourcing to Contract Research Organizations (CROs) to complete studies has become a foundation for pharmaceutical and device companies. With the lengthy drug development and approval process, it is nearly impossible to have complete study teams kept as full-time employees as the workload continually ebbs and flows. One of the challenges of outsourcing is selecting the right partner and then maintaining a team atmosphere where everyone takes ownership of the study. Key considerations when collaborating successfully with a CRO are selecting the right partner by knowing what questions to ask; establishing a foundation for the partnership with clear expectations, goals, and communication; and maintaining a sense of ownership in the work that has been outsourced. This web seminar will address the key criteria in selecting a partner, as well as review the necessary processes to foster positive relationships and allow for high quality performance of the CRO.

August 11, 2015

Barnett International

Essential Documentation in Clinical Trials at Research Sites

1:00 PM - 3:00 PM Eastern

Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance.

August 17, 2015

Barnett International

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

9:30 AM - 11:00 AM Eastern

In an effort to increase transparency, highlight potential conflicts of interest, and ultimately decrease healthcare costs, one element of the Patient Protection and Affordable Care Act (PPACA) – the Sunshine Act – requires disclosure of payments or transfer of value to physicians. These physicians can also be involved in clinical research as Investigators, in which case additional information is required to be reported. Released in February 2013, the final rule requires applicable manufacturers of covered drugs, devices, and biological supplies to gather and report information to be listed on the public website. This web seminar will address the requirements for reporting of information derived from clinical research as well as exceptions for reporting.

August 17, 2015

Barnett International

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

1:00 PM - 2:30 PM Eastern

The regulations require that sponsors ensure the selection of qualified monitors and the proper monitoring of clinical investigations. However, sponsors are frequently cited by the FDA for failure to meet those requirements. These regulatory communications note that although monitors might have identified issues, they did not appreciate the significance of those findings. As a result, opportunities to promptly secure compliance might be missed.

August 17 - September 28, 2015

Barnett International

30-Hour Clinical Project Management Fundamentals Certification Program

1:00 PM - 4:00 PM Eastern

In today’s outsourcing environment, the need for strong project management skills is greater than ever. This comprehensive hands-on 30-hour course is designed to provide the tools necessary to become a strong project manager in clinical research. Whether you are looking to become a clinical research project manager, you are already in an entry-level project manager role or you have become an “accidental” project manager by assignment, this program will provide you with project management skills development as well as the necessary tools and processes required to successfully manage projects in clinical research settings. The course includes an emphasis on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. Discussions, exercises, and tools are practically oriented with an emphasis given to practical application of key concepts and principles.

August 18, 2015

Barnett International

Fraud in Clinical Research: An Overview

12:30 PM - 2:30 PM Eastern

Fraudulent activities in clinical research undermine clinical research professionals’ ability to meet their obligations for ensuring credible data is obtained from protected participants. This web seminar provides an overview of fraud in clinical research and its potential impact on the industry and the public’s health.

August 19, 2015

Barnett International

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs

12:00 PM - 1:30 PM Eastern

This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.

August 20, 2015

Barnett International

Risk-Based Auditing: Effective Compliance Strategies

12:30 PM - 2:30 PM Eastern

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).

August 20 - October 29, 2015

Barnett International

30-Hour Clinical Research Auditing Certification Program

6:00 PM - 9:00 PM Eastern

The online 10-Week Clinical Research Auditing Certification Program provides a comprehensive introduction to clinical research and the job function of the Clinical Quality Assurance Auditor for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or transitioning into Good Clinical Practice (GCP) auditing. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the GCP auditor.

August 24, 2015

Barnett International

Case Report Form Design, Strategy, and Standards

9:30 AM - 11:30 AM Eastern

The phrase "garbage in, garbage out" can be applied to the data collection efforts in clinical trials. To avoid this pitfall, it’s important to be thorough in the evaluation of the data collection items that will validate the protocol hypothesis endpoints and statistical analysis. It’s also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that the data are in compatible format. With this goal in mind, it’s essential for data collection to be consistent, concise and compatible – hence the need for standards. CDISC and CDASH are instrumental in the establishment of these standards. This web seminar will discuss the timing of Case Report Form (CRF) design in relation to clinical trial startup and the team that will contribute to the data collection recommendations. We will review the resources utilized in determining what data collection is required and the current standards – CDISC and CDASH – for CRF data content. Best practices for CRF design as documented by the Society for Clinical Data Management Good Clinical Data Management Practices (SCDM GCDMP) will also be presented.

August 24, 2015

Barnett International

Data Management Plan Creation: Content and Rationale

1:00 PM - 2:30 PM Eastern

A well-designed Data Management Plan (DMP) provides a detailed description of how to handle data under any foreseeable circumstances and establishes processes for how to deal with unplanned issues. The DMP is study specific, is considered a “living document,” and is subject to audit; therefore, it is important to understand the content requirements and rationale for its creation. In this web seminar, we will focus on the importance of the creation of a DMP and the expected content that this document should contain. Attendees will be provided with a sample template for review.

August 25, 2015

Barnett International

State Laws Governing Clinical Trial Regulatory Compliance

9:30 AM - 11:00 AM Eastern

Although many clinical trial sponsors and investigators focus primarily on FDA regulations related to the conduct and design of clinical trials, their failure to comply with state laws and regulations may expose sponsors, investigators, IRBs, institutions, or individuals may call into question the potential integrity of clinical data. Today’s U.S.-based clinical trials must meet not just federal requirements, but an increasingly complex array of state-specific requirements, many of which are critical and foundational to clinical studies. The capacity to consent to experimental therapy has its foundational basis and is governed by state law. In this web seminar, we will review many of these key areas, and discuss specific differences. Learners will be provided with examples from more than a dozen practical areas, including age of consent, capacity to consent, IRB and clinical protocol requirements, notification of state agencies, experimental drug dispensing requirements, HIV testing rules, genetic testing, and legal representatives. Also, we will explore strategic considerations that certain states afford specific therapeutic classes. Learners will have the opportunity to ask direct questions regarding clinical trial requirements in their research state.

August 25, 2015

Barnett International

Data Quality in Clinical Trials: Rationale and Impact

12:30 PM - 2:30 PM Eastern

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

August 26, 2015

Barnett International

Establishing a Risk Management Framework for Clinical Trial Conduct and Oversight

1:00 PM - 2:30 PM Eastern

As many organizations move to, or contemplate, a risk-based approach to trial conduct and quality management, the published regulatory agency documents and industry think tank publications fall short in providing sponsors, CROs, and clinical vendors the framework—a comprehensive, systematic, structured approach to implementing risk management. This web seminar will provide an overview of a risk management reference model for use that has been adopted by other industries and is referenced in the FDA Guidance of 2013, “Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring.”

August 26, 2015

Barnett International

Quality by Design in Clinical Research: Is This Only for the Protocol?

3:00 PM - 4:30 PM Eastern

Over the past few years, Quality by Design (QbD) for clinical trials has been a focus for protocol development and execution. However, even though it is increasingly expected of the industry by regulatory agencies, translating this QbD approach into “building in quality for the business” is rarely shared for the “how do I do this?” This web seminar will de-code and translate QbD and quality for the research enterprise with examples that will solidify the concepts and framework presented for use within any organization. We will discuss the critical first step of defining quality; how to simplify QbD; how QbD and Quality Management Systems (QMS) relate to each other; determining whether your organization has these in place; what the best QbD principles and methods are; how to go beyond plans and create checklists for quality; and, finally, strategies for effective implementation.

August 27, 2015

Barnett International

Clinical Evidence Writing for Medical Device Regulatory Submissions

9:30 AM - 11:00 AM Eastern

Data used to support regulatory submissions comes from many sources. Clinical evidence can be found in the published literature, company complaints, and in publicly available databases like the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. In this web seminar, we will review how to gather and extract pertinent data from these sources to develop an appropriate analysis for your product and submission. Attendees will learn how to identify quality clinical evidence and utilize it in regulatory submissions.

August 27, 2015

Barnett International

Drug and Device Regulatory Submissions: A Comparison

1:00 PM - 2:30 PM Eastern

This web seminar is designed to provide details on what goes into FDA regulatory submissions for drugs and devices, and highlight the differences between the programs and Centers (CDER and CDRH) dealing with these products. Drug submissions may include an Investigational New Drug Application (IND), a New Drug Application (NDA), 505(b)(2) application, an Abbreviated New Drug Application (ANDA) for generic drugs, orphan drugs and supplemental filings, and contain information on manufacturing controls and clinical trial outcomes. Device submissions may include 510(k), PMA and PDPs, and de novo applications. Requirements for device submissions will depend on the device type and classification, as well as the available performance and safety information. The decision pathways needed to ensure the necessary information has been provided will be presented.

August 28, 2015

Barnett International

Informed Consent Guidance: Regulatory Updates

1:00 PM - 2:30 PM Eastern

Conducting the informed consent process is one of the most critical tasks to be completed by a research site. It’s essential that a subject clearly understands the language in the consent form and that their rights, safety, and welfare are not jeopardized. In this web seminar, we’ll look at the essential language in the informed consent document through review of the FDA regulations and guidance documents, including the March 2015 draft guidance, “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers,” the September 2011 “Guidance on Exculpatory Language in Informed Consent,” and additional regulatory updates.

August 31, 2015

Barnett International

Strategies for Ensuring Good Documentation Practices (GDP)

9:30 AM - 11:00 AM Eastern

Good Documentation Practice (GDP) in clinical research is a baseline expectation; however, there are no set guidelines around what comprises GDP in a Good Clinical Practice (GCP) environment. In this web seminar, we will look closely at the key features of GDP by first examining the question: What is a document? At its core, a document is information (meaningful data) and its supporting medium, which could be in the form of paper, CD, computer files, or microfilm. Documentation is a process which comprises multiple steps: Recording of data, review of documents, approval of documents, issuance and disposal of documents, retrieval of documents, and presentation of documents. In addition, this web seminar will examine the issues identified when documentation has been subject to agency review, and the steps that can be taken to ensure that your approach to clinical trial documentation demonstrates the quality processes that have been applied to your documentation efforts.

August 31, 2015

Barnett International

Risk-Based Monitoring: The Data Management Connection

12:30 PM - 2:30 PM Eastern

The final guidance, "Guidance for Industry: Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring” was released in August 2013. To quote from the new guidance, “… monitoring refers to the methods used by sponsors of investigational studies, or CROs delegated responsibilities for the conduct of IND studies, to oversee the conduct of and reporting of data from clinical investigations, including appropriate Clinical Investigator supervision of study site staff and third party contractors."

August 31, 2015

Barnett International

Building Relationships with Clinical Research Sites

1:00 PM - 2:30 PM Eastern

Relationships between sites and sponsors are often strained, and poor communication can interfere with having a productive study. Sites are contacted by multiple personnel during the study start-up process, and perhaps even during the study. By focusing on building relationships with the sites, the delays and errors in the startup and ongoing study process can be avoided. It is critical that the individuals working with the sites are in a position through training, knowledge, and support to positively reflect the sponsor and to ensure there is no gap in communication. This web seminar will focus on a variety of techniques for clinical study teams to use in building stronger relationships with the sites. Real-life scenarios and problem solving techniques will be discussed based on what can appear to be unreasonable monitor and sponsor requests to the site research staff.

September

September 1, 2015

Barnett International

Case Report Form Design, Strategy, and Standards Workshop

9:00 AM - 4:00 PM Eastern

According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): “…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.”

September 1, 2015

Barnett International

Detecting Risk Signals in Protocols, Data, and Monitoring

9:30 AM - 11:00 AM Eastern

In an environment where remote monitoring and management techniques are becoming the daily practice, preventative measures need to be implemented to identify risks. You need to be able to identify protocol data thresholds and parameters for risks to establish management and escalation triggers. As data becomes available in real time, you should not be waiting to intervene until deviations become a “trend” before intervention is implemented; you need to know how to look for outliers and “red flags” on a daily basis. With the increasing use of CROs and vendors, it is essential that best practices are established for identifying risk signals in management and monitoring practices. In this web seminar, we will discuss how to detect risk signals in protocols, data, and monitoring based on risk-based quality management, industry guidances, and practical application.

September 1, 2015

Barnett International

Investigational Product Accountability Best Practices

1:00 PM - 2:30 PM Eastern

One of the top regulatory findings both in the U.S. and in global inspections is related to investigational product (IP) accountability. In this web seminar, we will discuss the common sources of error, recommend procedures and training techniques, and evaluate the differences in investigational and non-investigational products. Investigator and sponsor responsibilities will be described, as well as “best practices” for implementation of those responsibilities.

September 2, 2015

Barnett International

Final FDA Guidance: How to Complete the FDA Form 1572, Adequately and Accurately

1:00 PM - 3:00 PM Eastern

Proper completion of the Statement of Investigator has been greatly debated. Many stakeholders differ in opinions on what is accurate and adequate in completing this form. For example, who should be listed as sub-investigators, do we need to complete a 1572 for certain projects, and so forth. This web seminar will review the 2010 FDA information sheet and answer many of the questions about how to properly complete the form. The course will also discuss what is still not clear even after the guidance and how to get the answers.

September 3, 2015

Barnett International

Strategies for Developing Effective Training and Facilitation Skills in Clinical Research

9:30 AM - 11:00 AM Eastern

In clinical research, there is an on-going need to conduct training whether it is at the onset of a study, due to a change in staff or new staff, as a result of an amendment, or because of an identified noncompliance issue during a study. If our goal in training is to pass on knowledge and to ask learners to apply that information, we need to consider our approach in how to make this happen. It is important to consider how essential every communication is within research; the information shared can have a huge impact on study timelines, data integrity, and compliance. If information is not internalized by the learner, then the time spent discussing it is a waste and the consequences may be significant. In this web seminar, training and facilitation methodology, skills, and fundamentals will be discussed. We will focus on the practical application and tools needed to ensure that an audience is able to remember and apply the information shared.

September 3, 2015

Barnett International

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components

12:00 PM - 2:30 PM Eastern

Current societal events have influenced the increased use of an electronic medical record (EMR), one being the promotion of a national electronic medical record. More and more research sites are using an EMR for all or part of their case histories for research subjects. The industry has defined the characteristics that source documents in any form must include, and 21 CFR Part 11 includes standards for electronic source data. Challenges in monitoring the original source document have been growing and unaddressed in many situations. The FDA’s final guidance document for 21 CFR Part 11 supports certain characteristics that EMRs should include, but many site electronic records do not meet the requirements. This web seminar will discuss assessment of EMRs, ideal monitoring vs. contingency planning, and risk management.

September 3, 2015

Barnett International

Protocol Deviations: Documenting, Managing, and Reporting

1:00 PM - 3:00 PM Eastern

According to both U.S. regulations and the ICH Good Clinical Practice: Consolidated Guideline, Clinical Investigators are required to conduct a clinical trial in compliance with the investigational plan/protocol. Protocol deviations should not be implemented without sponsor agreement and the prior approval/favorable opinion from the IRB/IEC, except when necessary to eliminate an immediate safety issue for research subjects. However, unapproved protocol deviations occur in every study and at every site.

September 4 - November 13, 2015

Barnett International

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

8:30 AM - 11:30 AM Eastern

The Clinical Research Coordinator (CRC) has a vital role in the conduct of a clinical trial and is a key liaison between the investigator, subject, IRB, and sponsor. The online 10-Week Clinical Research Coordinator (CRC) On-Boarding Program will provide a comprehensive introduction to clinical research and the job functions of the CRC for both drug/biologic and device trials. This program will provide core skills and encourage critical thinking to those individuals looking to support, facilitate, and coordinate the daily activities of clinical trials. Case studies and industry best practices will be presented to underscore how the learning objectives apply directly to the responsibilities of the CRC.

September 4, 2015

Barnett International

CRO Partnership Management

9:30 AM - 11:00 AM Eastern

In an environment where we are outsourcing multiple tasks, it is valuable to understand the dynamics of relationship building and the application of practical management. Extensive knowledge and skill are required to manage large teams, especially when the majority of the team functions outside of your organization. This web seminar provides an overview of Contract Research Organization (CRO) partnership building, management, application of root cause analysis (RCA) and strategies for problem solving.

September 4 - November 13, 2015

Barnett International

10-Week Clinical Research Associate (CRA) On-Boarding Program

12:00 PM - 3:00 PM Eastern

The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA. The course provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biologic, and device trials. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both U.S. and global audiences. Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, and scenario review, as well as application-based homework assignments.

September 4, 2015

Barnett International

Navigating the Unusual Consent Process

1:00 PM - 2:30 PM Eastern

Informed consent is a challenging process with any clinical trial subject; ensuring understanding and agreement with a form detailing a medical study and filled with legal jargon can be time consuming and stressful. In addition, when we are faced with unusual consent situations, and the rules are not readily available, we run into questions regarding ethics and regulatory ramifications. This web seminar is designed to address some of the more unusual consent situations and address the regulations, guidances, and input from ethics committees on developing the consent document and managing the informed consent process. Considerations for use of the short form, legally authorized representatives, exceptions to the standard consent process, pediatric assent, and challenges with impaired subjects will be discussed.

September 8, 2015

Barnett International

Tools for Trainers: Clinical Research Job-Aids and Checklists

1:00 PM - 2:30 PM Eastern

As adult learners, clinical research professionals are motivated by an understanding of how training interactions directly impact their work lives. The use of job aids and checklists can serve to satisfy this need by providing a resource to someone performing a task exactly when and where they need it. These tools can also serve to reinforce the training as participants return to the workplace, resulting in a greater likelihood that the organization’s performance goals will be met. In some cases, a job aid alone can replace unnecessary training expenses.

September 9, 2015

Barnett International

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

1:00 PM - 2:30 PM Eastern

Partnerships with clinical vendors are critical to the success of the trial. Sponsors, as well as vendors who hire other vendors, require both performance and quality oversight. Whether your organization hires different vendors per protocol/program, or you’re in a preferred provider partnership model, you always encounter potential risks. This web seminar will provide a systematic, structured, proactive approach to risk management in outsourced clinical trials. We will discuss the internal and external factors for the organization to identify, assess, manage, and continuously monitor throughout the life of a project and/or partnership (e.g., protocol, investigational plan, regions, sites, vendors, and resources).

September 9, 2015

Barnett International

Re-Engineering the RFP and Bid Defense Meeting to Effectively Manage Risk and Quality

3:00 PM - 4:30 PM Eastern

In this web seminar, we will review the re-engineering of the Request for Proposal (RFP) and bid defense meeting to target identification of risks for the potential services to be awarded to your CRO, vendor, or supplier, whether a preferred partnership model, a “company approved list,” or based solely on project needs. This approach also gives the provider the opportunity to communicate their ability and willingness to adjust their approach and methods beyond the RFP, thus beginning a dialogue regarding management and quality oversight methods early on in the partnership. This improved process drives business efficiencies and cost savings now, rather than later during trial execution, and helps identify impact on protocol and data integrity if performance is inadequate.

September 10, 2015

Barnett International

Introduction to Statistics for Non-Statisticians

9:00 AM - 12:00 PM Eastern

This web seminar is intended for clinical research professionals who have little or no background in statistics. In it, we will cover the basic statistical concepts needed to understand the roles statistics play in health research. The topics addressed include types of variables, levels of measurement, descriptive statistics, precision, confidence intervals, and an introduction to hypothesis testing. This web seminar is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Emphasis will be placed on understanding statistical information and not on calculations or statistical formulae.

September 10, 2015

Barnett International

Introduction to Statistics for Non-Statisticians

9:00 AM - 12:00 PM Eastern

This web seminar is intended for clinical research professionals who have little or no background in statistics. In it, we will cover the basic statistical concepts needed to understand the roles statistics play in health research. The topics addressed include types of variables, levels of measurement, descriptive statistics, precision, confidence intervals, and an introduction to hypothesis testing. This web seminar is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Emphasis will be placed on understanding statistical information and not on calculations or statistical formulae.

September 10, 2015

Barnett International

Subject Enrollment: Creating Effective Enrollment Models

9:30 AM - 11:00 AM Eastern

Although clinical trial subject enrollment has been debated, analyzed, and implemented in many forms, study teams still face ongoing challenges. Although study sites are often blamed for sluggish enrollment, the challenges are study-specific and can be sponsor-related. Moreover, some sponsors are going global in order to recruit subjects, while failing to access the many untapped patient populations in native western countries, such as the U.S., Canada, and Europe. This web seminar provides an overview of the changes driven by globalization of clinical research, looks at subject enrollment challenges, and addresses patient engagement issues. Innovative tools for improving clinical trial subject enrollment will be provided.

September 10, 2015

Barnett International

Informed Consent Procedure: Lessons Learned from Inspection Findings

1:00 PM - 2:30 PM Eastern

Informed consent irregularities remain one of the leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples of FDA Warning Letters addressing informed consent inspection findings, and discuss appropriate corrective and preventive actions (CAPA). Learners will come away with solutions to avoid common informed consent pitfalls, and ultimately, avoid inspection findings. Participants are encouraged to share their experiences as we discuss methods to aid in compliance through appropriate techniques for the informed consent process. Tools will also be provided to assist in compliance.

September 14, 2015

Barnett International

Key Components of Strategic Clinical Research Operational Planning

9:00 AM - 11:00 AM Eastern

This web seminar will examine the concepts and applied techniques for cost estimation (PERT analysis, bottom-up, top-down, etc.), budget development, risk management, and quality assurance for clinical research projects. Project management principles and methodology are provided with a special focus on planning, controlling, and coordinating individual and group efforts. Key topics include organization strategy and project selection, defining a project, developing a project plan, scheduling resources, risk analysis, work breakdown structures, project networks, process mapping, and building high performance teams. The needs of project managers who aren’t familiar or experienced with specific technical tasks involved in clinical trial management will also be discussed.

September 14, 2015

Barnett International

ABCs of Clinical Research for Clinical Administrative Support Staff

9:00 AM - 11:30 AM Eastern

This course provides the background needed to become an integral part of the clinical research team (for drugs and devices) and explores the need to understand the rationale behind quality performance and team-playing. The roles and responsibilities of Clinical Administrative Support will be discussed in terms of obligations to the study team and the importance of compliance with Standard Operating Procedures and Standard Office Practices. Although the course is designed for administrative staff with less than one year experience, those with some experience may also find this course helpful in providing the rationale for doing tasks in a specific manner, refining their skills, and sharing their experiences and helpful techniques with their colleagues.

September 14, 2015

Barnett International

ABCs of GCP and the 13 Principles of ICH

1:00 PM - 2:30 PM Eastern

This web seminar provides the basic concept of Good Clinical Practice (GCP). Participants will learn the goals of GCP and its common elements (FDA regulations and ICH Guidelines) defining the quality system of mutual accountability between the sponsor, investigator, IRB/IEC, and the regulatory authority. The basic roles and responsibilities of each stakeholder will be discussed in relation to these criteria. The 13 principles of ICH GCP will be discussed in a practical manner to ensure compliance with all regulatory requirements.

September 15, 2015

Barnett International

Drug and Device Regulatory Submissions: A Comparison

9:30 AM - 11:00 AM Eastern

This web seminar is designed to provide details on what goes into FDA regulatory submissions for drugs and devices, and highlight the differences between the programs and Centers (CDER and CDRH) dealing with these products. Drug submissions may include an Investigational New Drug Application (IND), a New Drug Application (NDA), 505(b)(2) application, an Abbreviated New Drug Application (ANDA) for generic drugs, orphan drugs and supplemental filings, and contain information on manufacturing controls and clinical trial outcomes. Device submissions may include 510(k), PMA and PDPs, and de novo applications. Requirements for device submissions will depend on the device type and classification, as well as the available performance and safety information. The decision pathways needed to ensure the necessary information has been provided will be presented.

September 15, 2015

Barnett International

Applied Clinical Statistics in Centralized Monitoring

1:00 PM - 2:30 PM Eastern

With the release of FDA’s guidance on risk-based monitoring (RBM), the FDA is requiring centralized monitors to have adequate training to perform centralized monitoring activities. Moreover, with the increase in the availability of clinical operational data, and with more biopharmaceutical and medical device enterprises outsourcing, clinical operations teams need to have the necessary skills to centrally and efficiently monitor and manage their clinical trials. This web seminar will provide a brief background as to how the industry is changing, address why centralized and RBM is gaining importance, and offer applied clinical statistical training and tools that can be utilized towards centralized clinical trial monitoring applications and identifying site underperformance. These tools are also flexible towards clinical business operations. Attendees will learn to interpret and graph histograms, quantify risk in histograms and datasets, identify clinical trial underperformance, and utilize minimum random sampling for RBM in histograms and datasets.

September 15, 2015

Barnett International

Clinical Evidence Writing for Medical Device Regulatory Submissions

1:00 PM - 2:30 PM Eastern

Data used to support regulatory submissions comes from many sources. Clinical evidence can be found in the published literature, company complaints, and in publicly available databases like the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. In this web seminar, we will review how to gather and extract pertinent data from these sources to develop an appropriate analysis for your product and submission. Attendees will learn how to identify quality clinical evidence and utilize it in regulatory submissions.

September 16, 2015

Barnett International

Adverse Event Monitoring for CRAs

12:00 PM - 2:00 PM Eastern

During monitoring visits, one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA serves as the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety, regulatory, and ICH definitions will be reviewed and applied to the monitoring process in this web seminar. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

September 16, 2015

Barnett International

Risk-Based Monitoring for Sites: Prepare Your Site for Success

1:00 PM - 2:30 PM Eastern

Over the past few years, a new term has emerged in the clinical research industry: Risk-Based Monitoring (RBM). What is it? Why is it becoming more widely used? How does it impact Investigators and sites? This web seminar will provide an overview of the principles of RBM and describe how this new approach to monitoring differs from “traditional” monitoring. Learners will gain an understanding of both regulatory and industry factors influencing the adoption of Risk-Based Monitoring. This web seminar will help participants anticipate the possible changes brought on by RBM, and provide strategies to prepare their sites for success.

September 17, 2015

Barnett International

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

8:30 AM - 11:30 AM Eastern

Negotiating study contracts and budgets is critical for the future success of the clinical research site. This web seminar provides strategic skills and best practices for contract negotiations and budget development. Learners will also review and practice the art of negotiation.

September 17, 2015

Barnett International

Critical Decision Points in Design and Conduct of Patient Registries

12:00 PM - 1:30 PM Eastern

Patient registries are based on principles of observational research and offer remarkable flexibility in design and applications. They have demonstrated value in both the biopharmaceutical and the medical device arenas. Patient registries are appealing to physician investigators, and can serve as a centerpiece or as an adjunct to a product’s late-phase scientific and promotional strategy.