CenterWatch

Webinars

To have your webinar included, please contact jobwatch@centerwatch.com.

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.

September 21, 2015

Barnett International

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

9:30 AM - 11:30 AM Eastern

Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This web seminar will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).

September 21, 2015

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

9:30 AM - 11:30 AM Eastern

Investigator Initated 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.

September 21, 2015

Barnett International

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance

12:30 PM - 2:30 PM Eastern

As the use of electronic source documentation (eSource) increases, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, the FDA issued a draft guidance regarding the use of eSource, providing direction on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. A final guidance was released in September 2013 focusing on identification and specification of authorized source data originators, the creation of data element identifiers to facilitate examination of the data audit trail, capture of source data into the eCRF, and Investigator responsibilities. This web seminar will review how the requirements for paper source documentation translate to the electronic source document as well as examine real-world examples of the FDA’s review of eSource.

September 21, 2015

Barnett International

Monitoring Medical Device Trials: An Introduction

1:00 PM - 2:30 PM 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.

September 22, 2015

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

8:30 AM - 11:30 AM 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.

September 22, 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.

September 22, 2015

Barnett International

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

12:30 PM - 2:30 PM Eastern

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

September 23, 2015

Barnett International

Adequate Sponsor Monitoring Systems in Anticipation of FDA Sponsor GCP Inspection

12:30 PM - 2:30 PM Eastern

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

September 23, 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.

September 24, 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.

September 24, 2015

Barnett International

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

9:30 AM - 11:00 AM 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.

September 24, 2015

Barnett International

Good Clinical Practice (GCP) for Medical Devices: ICH GCP and ISO 14155

1:00 PM - 2:30 PM Eastern

Both ICH E6 and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use ICH as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.