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Webinars

May | June |

May

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.

June 5 - August 28, 2015

Barnett International

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

8:30 AM - 11:30 AM 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.

June 5, 2015

Barnett International

Social Media in Clinical Research: Effective, Innovative, and Compliant Applications

9:00 AM - 11:00 AM Eastern

The use of social media in all aspects of the research enterprise has grown exponentially. Researchers from across disciplines and institutional types are finding innovative ways to facilitate research, from online recruitment mechanisms to informed consent portals. Concurrently, researchers and their ethics review boards have been grappling with ethical and regulatory challenges as technologies continue to change rapidly, resulting in a flurry of new questions: Can I use social media to find “lost to follow up” subjects? Can I join a support group to find subjects? What regulations exist around the use of social media? Just what is public information? This web seminar will provide an overview of Institutional Review Board (IRB) considerations of social media in research, including those major ethical challenges and data security issues that may arise with the use of social media for recruitment, consent processes, data collection, and data dissemination.

June 5, 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.

June 8, 2015

Barnett International

Introduction to Data Management

12:30 PM - 2:30 PM Eastern

This web seminar provides an excellent introduction to clinical research data management, focusing on processes and their rationale, making it ideal for the new data manager and other individuals who wish to learn basic clinical data management functions.

June 8, 2015

Barnett International

Key Components of Strategic Clinical Research Operational Planning

5:00 PM - 7:00 PM 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.

June 9, 2015

Barnett International

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

12:00 PM - 3:00 PM 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.

June 10, 2015

Barnett International

Placebo Trials for Medical Devices: FDA's Steps to Ensure Reliability of Medical Devices

1:00 PM - 2:30 PM Eastern

As of 2014, device companies must consider the placebo effect in clinical trials and how placebo controls will affect their regulatory approval pathway. Randomized, placebo controlled trials are not new to those in the pharmaceutical industry, but they have not traditionally been the norm for device trials. Approval in the EU does not assure approval in the U.S. Will Congress be asked “to ensure that all devices provided to patients be safe and effective” rather than “reasonably” safe and effective? What are the ethical considerations? How will this issue affect conducting medical device clinical trials in the U.S. and abroad? Sponsors should be prepared to discuss and defend their position on the necessity of a placebo controlled trial. This web seminar will provide strategies for adapting to this changing regulatory landscape. The course instructor, a former FDA insider, will share case studies to help sponsors and investigators better prepare for unanticipated FDA questions.

June 11, 2015

Barnett International

FDA Drug Approval Process

8:30 AM - 11:30 AM Eastern

This web seminar provides an overview of what is required to take a new drug from research to market. We will begin by reviewing the contents of an IND, and then follow the process of an IND submission. From there, the contents and approval process of an NDA submission will be discussed. This web seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and help attendees become familiar with the regulatory landscape in which INDs and NDAs are developed and approved.

June 11, 2015

Barnett International

Use of Notes to File in Clinical Trial Essential Documentation

12:00 PM - 1:30 PM Eastern

Notes to File (NTF), also known as Memo to File, are commonly used as essential documentation in sponsor and site files. Many times the content of the NTF does not serve the purpose for use or serves no purpose at all. This web seminar will discuss the appropriate and inappropriate uses of NTF, the questions to ask to determine if NTF would be beneficial, and the components of a quality NTF, if being used.

June 12, 2015

Barnett International

Monitoring Phase I Clinical Trials

12:00 PM - 2:00 PM Eastern

Phase I trials require an additional monitoring skill set. The Clinical Research Associate (CRA) assessment focus changes in many monitoring practices, from the Informed Consent Form to data review of PK sampling. Most CRA trainings do not test or provide practicum for the unique focus of a Phase I trial. This web seminar will identify the differences in skills and review specific components for monitoring studies in this phase of research. References from GCP to support monitoring activities will be presented, as well as case studies to apply presented concepts.

June 15, 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.

June 15, 2015

Barnett International

Monitoring Medical Device Trials: An Introduction

9:30 AM - 11:00 AM Eastern

This web seminar will provide the core concepts involved in monitoring medical device studies, including activities conducted at the investigator site, communication between monitor visits, and monitoring with centralized systems. We will explore the monitoring concepts as provided by the FDA in the Risk-Based Monitoring Guidance of 2013, as well as the ICH as interpreted for medical device trials. The basics of clinical monitoring and appropriate documentation to support adequate oversight of the study will be covered. Sponsor responsibilities and the role of the Clinical Research Associate/Monitor will be explored.

June 15, 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.

June 16, 2015

Barnett International

Risk-Based Site Monitoring

12:00 PM - 1:30 PM Eastern

In the current GCP regulatory climate, risk-based decision making should be supported within the clinical Quality System. A management approach used in many industries where performance is critical under tight timelines for regulated activities, risk-based decision making makes sense for such activities as sponsor monitoring in clinical research. Applying a risk-based approach to the monitoring and site management should be based on a given project’s risk profile. A risk- based approach can address current monitoring practices that are costly and ineffective, and help projects meet financial and compliance goals. This web seminar will present the concepts and case scenarios of risk-based monitoring (RBM).

June 17, 2015

Barnett International

Developing Clinical Study Budgets for Sponsors

12:00 PM - 2:30 PM Eastern

In an environment where studies are becoming more challenging to execute and taking more resources and time than anticipated, it is key to develop a solid and flexible budget to allow for study execution challenges. In developing a budget it is critical to address all standard line items such as reimbursement for procedures, but how can the oversight and follow-up time be accurately calculated? How does Fair Market Value (FMV) criteria factor into budget development? What questions should be asked to determine additional, unwritten, study expectations? What are some key elements leading to delayed budget negotiation and approval? This web seminar will address the fundamentals of budget development and considerations for ensuring that budgets are developed fairly to ensure that sites are appropriately reimbursed for study expectations.

June 18, 2015

Barnett International

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

9:00 AM - 10:30 AM 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.

June 18, 2015

Barnett International

Quality Risk Management in Clinical Trials and Pharmacovigilance

12:00 PM - 1:30 PM Eastern

The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

June 18, 2015

Barnett International

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

1:00 PM - 2:30 PM 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.

June 19, 2015

Barnett International

Introduction to Statistics for Non-Statisticians

12:00 PM - 3:00 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.

June 22, 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.

June 23, 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.

June 24, 2015

Barnett International

Auditor Emotional Intelligence

1:00 PM - 3:00 PM Eastern

Audits are often viewed as transactional and factual – and rightly so! They are transactional (a process carried out) and must be factual, devoid of as much personal bias and emotion as possible. However, the power of advanced soft skills in enhancing both the transactional and factual aspects of an audit cannot be underestimated. We have all heard stories of painful audits with auditors who possessed little to no soft skills. The use of appropriate, advanced soft skills serves to reinforce a culture of quality with the auditee. The most important soft skill a quality professional can possess is emotional intelligence.

June 24, 2015

Barnett International

EMA and FDA Inspections: Key Differences and Similarities

1:00 PM - 2:30 PM Eastern

The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) collaborated and performed official joint Good Clinical Practice (GCP) inspections of sponsors, CROs, and investigational sites between 2009 through 2011. Those collaborations have continued into 2014. In this web seminar, we will review the Report on the Pilot EMA-FDA GCP Initiative, and discuss the similarities and differences between EMA and FDA inspectors and inspection processes conducted over the last five years using recent examples of joint inspections. Clarification will also be provided for reporting of Serious Breaches in the UK along with a review of common inspection findings.

June 25, 2015

Barnett International

SDTM and CDASH: What's the Connection?

9:30 AM - 11:00 AM Eastern

Currently, the FDA requires that clinical trial data be electronically submitted in the Clinical Data Interchange Standards Consortium (CDISC) format for consideration for a new drug/biological approval. A significant element in this submission is the Study Data Tabulation Model (SDTM). This web seminar will examine the information defining the concepts of the SDTM as presented in the documentation Version 1.4. The purpose of data standards, benefits of applying these standards, and the relationship between datasets and records will be examined. The relationship between the standard for data collection instruments — also known as Clinical Data Acquisition Standards

June 25, 2015

Barnett International

Ensuring Success Through Smarter Site Selection and Study Feasibility

9:30 AM - 11:00 AM Eastern

Site selection is a complex dance between sponsors and sites. The wrong choice can have serious consequences, impacting quality, time, and finances for both the sponsor and investigator. In this web seminar, the steps for site selection and study feasibility will be discussed. Sponsors will learn the most critical questions to ask an investigator and staff to ensure quality and timely data as well as appropriate enrollment. Sites will learn how they can be proactive in the selection process and how to ensure the study is feasible. The process of site feasibility and selection will be outlined with key decision points for both sponsors and sites. Sites and sponsors will also learn what tools can help sites become “preferred” and achieve excellence. Tips for improving documentation and communication will be demonstrated through tools and worksheets, leading to successful collaboration between the site and sponsor and avoiding some common pitfalls. With careful consideration of placement of a clinical trial, learners can find success at closeout, audit, or inspection.

June 25, 2015

Barnett International

Current FDA and EMA Inspection Findings: Lessons Learned

1:00 PM - 2:30 PM Eastern

Failure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of 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 from the current top inspection findings, and discuss appropriate corrective and preventative actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future. Correct conduct according to GCP will be discussed and lessons learned applied to help prevent these findings from occurring again. Learners are encouraged to share their experiences as participants discuss methods and tools to aid in compliance through appropriate techniques for ICH-GCP compliance. Tools will be provided to assist clinical research personnel in their efforts to be ICH-GCP compliant.

June 25, 2015

Barnett International

Strategies for Ensuring Good Documentation Practices (GDP)

1:00 PM - 2:30 PM 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.