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Webinars

April | May | June |

April

April 27, 2015

Barnett International

How to Write Effective Monitoring Reports and Communications Workshop

9:00 AM - 4:00 PM Eastern

Clinical Monitors (CRAs) must document many details of the happenings at investigational sites, including Confirmation Letters to sites, Monitoring Visit Reports, Follow-Up Letters to sites, Telephone Contact Reports, Email/Faxes to sites, and Queries and Notes to File (NTF). All of these become essential documents as they demonstrate the compliance of the monitor and, thus, the sponsor in the conduct of the clinical trial. These are all eligible for inspection by the regulatory authorities at any time both during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics, and devices. Effective writing skills are, therefore, extremely important so that we show the diligence and detail involved in effective monitoring.

April 27, 2015

Barnett International

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada

12:30 PM - 2:30 PM Eastern

As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. Regulatory agencies’ recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventive action plans are developed to secure compliance. This web seminar will examine the trends in recent regulatory communication and open discussion for review of acceptable versus unacceptable responses.

April 28, 2015

Barnett International

Good Clinical Practice: Practical Application and Implementation

9:30 AM - 11:30 AM Eastern

This web seminar provides an overview of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how Quality Systems, or a lack thereof, impact overall data quality and regulatory risk. This web seminar is designed for professionals with at least two years of experience in the clinical research industry.

April 28, 2015

Barnett International

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual

12:30 PM - 2:30 PM Eastern

As scrutiny of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research intensifies, companies are using their quality assurance resources to review internal (and vendor) systems to ensure compliance within a changing regulatory environment. A systematic application of the Compliance Program Guidance Manual (CPGM) permits identification of regulatory risks during qualification and in-process audits. This web seminar will review the FDA’s current guideline for conducting inspections and how to apply them to assess Quality Systems. Assessment of the SOPs that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will also be discussed.

April 29, 2015

Barnett International

Negotiation Skills for Clinical Research Professionals

12:00 PM - 1:30 PM Eastern

The ability to negotiate effectively is a core competency for all clinical research professionals. Yet many people find negotiating to be an intimidating experience. Take this interactive web seminar and dramatically improve your ability to negotiate in any situation. With specific examples and real world case studies drawn from clinical research, you will be able to immediately implement the skills you learn with ease. This web seminar will provide a rich learning experience in implementing negotiation best practices.

April 29, 2015

Barnett International

Writing Clinical Study Protocols

12:00 PM - 3:00 PM Eastern

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

April 30, 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.

May

May 4, 2015

Barnett International

Informed Consent: Execution, Documentation, and Monitoring the Dynamic Process

12:00 PM - 2:30 PM Eastern

This web seminar presents the elements of the informed consent document and the components of the process. Industry specific scenarios are presented to reinforce important concepts, for example: Evaluating and documenting capacity to consent, voluntariness, when a HIPAA authorization is required, withdrawal of consent, and more. Discussions also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research.

May 5, 2015

Barnett International

Improving Readability of SOPs and Other Procedural Documents

12:15 PM - 2:15 PM Eastern

No one really likes reading SOPs. Whether this is a true “necessary evil” or not, this, in itself, makes it important that the associated pain is minimized. More often than not, the contents of the SOPs are simply “tossed” into a document with little ado. Such an approach perpetuates a vicious circle: First, the user, not being able to fully comprehend what they are reading, simply stops reading; then, authors, knowing the document won’t be read, don’t put effort into writing it. The by-product of these events is that compliance suffers.

May 6, 2015

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

12:00 PM - 2:00 PM Eastern

Investigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance.

May 6, 2015

Barnett International

Study Feasibility: Eliminating Low and Late Enrollment

12:30 PM - 2:30 PM Eastern

This web seminar is designed for sponsor/CRO personnel responsible for protocol design and development, country allocation, site selection, and study feasibility assessments. The current study feasibility assessment process is inefficient and is incapable of identifying the best investigative sites to conduct a clinical trial. Feasibility questionnaires and the current process are often not effective in predicting site success in implementing a given clinical trial. This session will explore novel approaches and technologies that can be used to significantly improve the feasibility assessment process at the protocol, country, and site level.

May 7, 2015

Barnett International

State Laws Governing Clinical Trial Regulatory Compliance

1:00 PM - 2:30 PM 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.

May 11, 2015

Barnett International

SOP Writing: How to Create, Implement, and Maintain User-Friendly SOPs Workshop

9:00 AM - 4:00 PM Eastern

In the world of clinical research, it would be difficult to find someone who hasn’t heard of Standard Operating Procedures (SOPs). Yet there remains great mystery in how to create an SOP.

May 11, 2015

Barnett International

Trial Master Files: Why They Are Important and How to Organize Them Workshop

9:00 AM - 4:00 PM Eastern

The Trial Master File is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations for a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50 that, “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.” The European Directive 2005/28/EC states that, “the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.” ICH GCP, Section 8.1 defines these essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements.

May 12, 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.

May 13, 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.”

May 14, 2015

Barnett International

Case Report Form Design, Strategy, and Standards

12:30 PM - 2:30 PM 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.

May 14, 2015

Barnett International

Drug Development and FDA Regulations

12:30 PM - 3:30 PM Eastern

This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.

May 15 - July 31, 2015

Barnett International

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

12:00 PM - 3:00 PM 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.

May 18, 2015

Barnett International

Principal Investigator Training: Roles and Responsibilities

12:00 PM - 3:00 PM Eastern

The roles and responsibilities of the Principal Investigator (PI) are essential for quality data and regulatory compliant clinical trials, but the PI remains an under-trained position in the industry. Because of the critical role the PI plays during a clinical trial, there is debate within the industry of mandatory certification for the PI and/or site accreditation. Documentation of industry training is essential. This web seminar reviews the clinical trial core competencies required for the Principal Investigator in accordance with the federal regulations, ICH GCP guidelines, and industry best practices.

May 19, 2015

Barnett International

Monitoring Oncology Clinical Trials

1:00 PM - 3:00 PM Eastern

This web seminar will provide attendees with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed.

May 20, 2015

Barnett International

European Pharmacovigilance Modules -- What Are They and Why They Are Important

1:00 PM - 2:30 PM Eastern

Since 2012, the European Medicines Agency (EMA) has developed, published, and modified directives regarding Post-Marketing Pharmacovigilance (PV), simply known as the EMA PV Modules. These modules and the inspectors’ expectations are currently considered the pharmaceutical, biotechnology, and device industries “gold” standard for PV processes for companies that market products on a global basis. In this web seminar, learners will be provided with the basics of the EMA PV Modules, specifically, what are they and why they are important for the U.S.

May 21, 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.”

May 21, 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.

May 27, 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.

May 28, 2015

Barnett International

How to Write Effective Monitoring Reports and Communications Workshop

9:00 AM - 4:00 PM Eastern

Clinical Monitors (CRAs) must document many details of the happenings at investigational sites, including Confirmation Letters to sites, Monitoring Visit Reports, Follow-Up Letters to sites, Telephone Contact Reports, Email/Faxes to sites, and Queries and Notes to File (NTF). All of these become essential documents as they demonstrate the compliance of the monitor and, thus, the sponsor in the conduct of the clinical trial. These are all eligible for inspection by the regulatory authorities at any time both during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics, and devices. Effective writing skills are, therefore, extremely important so that we show the diligence and detail involved in effective monitoring.

May 28, 2015

Barnett International

Data Management Plan Creation: Content and Rationale

9:30 AM - 11:00 AM 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.

June

June 1, 2015

Barnett International

Root Cause Analysis: Applying the Concept for Better Study Compliance Management

12:00 PM - 2:30 PM Eastern

Managing compliance in the research industry is vital to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, intervene, and then evaluate the effectiveness of the intervention. Without root cause analysis, interventions cannot be effectively identified and designed. This web seminar will present the scientific concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research, the sponsor, CRO, site, and Institutional Review Board (IRB).

June 2, 2015

Barnett International

Quality by Design: A Lean Six Sigma Approach to Risk-Based Monitoring

1:00 PM - 2:30 PM Eastern

Monitoring consumes 30-60% of an operational budget for clinical trials or clinical programs. To sustain growth and reinvest in innovation, sponsors must find viable alternatives to reduce the resource burn, as well as create efficient and effective solutions to increase regulatory compliance, data integrity, and patient safety. By utilizing the combined toolboxes of Lean Six Sigma (LSS) + Quality by Design (QbD), sponsors can continue to invest in innovative products while producing customer-centric/efficient operational processes that are highly adaptable, constantly reproducible, and consume fewer resources. LSS + QbD provides CRAs and other risk-based monitoring staff with an arsenal of analytical tools to conduct fewer on site monitoring visits yet monitor the site more effectively and in real-time.

June 3, 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).

June 4, 2015

Barnett International

Using Data to Identify Risk Indicators in Risk-Based Monitoring

1:00 PM - 2:30 PM Eastern

This web seminar will provide centralized monitoring techniques for prioritizing sites and patients in need of on-site monitoring and education. These techniques are useful when using either a risk-based monitoring approach or 100% Source Data Verification, and include both a priori “risk indicators” and dynamic error detection during study execution. Emphasis will be placed on how monitors, data managers, and statisticians can work together to prioritize the data at highest risk of causing problems and prevent errors in the database. Novel techniques for identifying fraudulent data will also be addressed. When monitors, data managers, and statisticians apply these techniques, they will be able to implement a successful risk-based monitoring plan that is practical and cost-effective, while improving the overall quality of the data.