CenterWatch

Webinars

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

May

May 13, 2016

Barnett International

eTMF Implementation Strategies

9:30 AM - 11:30 AM Eastern

Across the industry, organizations are moving towards an electronic Trial Master File (eTMF). Moving from a paper TMF to an eTMF is a large undertaking for any organization. The right approach to the project is critical to the implementation. In this web seminar, we will discuss the key activities including vendor selection, developing eTMF management processes that ensure a high quality TMF, implications of eTMF within your organization, and working with Contract Research Organizations (CROs) and sponsor partners during the implementation process. Successful planning and implementation will result in a high quality eTMF system that ensures the organization is inspection and audit ready.

May 13, 2016

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.

May 13, 2016

Barnett International

Centralized TMF Management: The CRO Sponsor Partnership

1:00 PM - 2:30 PM Eastern

Many sponsor organizations transfer responsibility for Trial Master File (TMF) management to their Contract Research Organization (CRO) partners. However, the CRO maintains TMF content for those activities for which they have been delegated. Generally a TMF is comprised of sponsor, CRO, and vendor content. The relationship between the CRO and the sponsor is critical in ensuring a quality TMF. This web seminar will explore critical activities and responsibilities on the part of the CRO and the sponsor. A successful partnership between these two groups is critical to ensuring an inspection ready file during and at the conclusion of the study...

May 16, 2016

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.

May 18, 2016

Barnett International

Good Clinical Practice: Practical Application and Implementation

12:30 PM - 2:30 PM 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.

May 19, 2016

Barnett International

Quality Systems: A Controlled Approach to GCP Compliance

12:30 PM - 2:30 PM Eastern

A Quality Systems approach to establishing and maintaining regulatory compliance allows sponsors to better leverage their resources and Clinical Investigators to meet their obligations for clinical research oversight. This web seminar will review the elements of a Quality System at the Clinical Investigator site and how it functions to proactively control site-level noncompliance.

May 23, 2016

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.

May 23, 2016

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...

May 24, 2016

Barnett International

Leading Teams in a Changing Clinical Research Environment

12:30 PM - 2:30 PM Eastern

Teams have become much more complex in the past 10 years. In the past, a team would be comprised of similar individuals in the same location driving on a fairly stable course towards its objectives. These tenets are no longer true. Trends are driving the need for more flexible, highly skilled teams...

May 25, 2016

Barnett International

Managing CRAs to Improve Study Outcomes

12:00 PM - 2:30 PM Eastern

Monitoring a clinical trial is a required activity completed by sponsors of FDA regulated research that significantly affects the outcomes of product development and approval. Effectively managing the performance of Clinical Research Associates (CRAs) by sponsors is essential. Performance Management and Improvement is a science involving logical processes and applications. This web seminar will present the concepts of the Human Performance Improvement (HPI) Model and apply it directly to the management of the CRA to promote improvements. The HPI CRA Management Model will be presented and applied via case scenarios for better understanding.

May 25, 2016

Barnett International

Key Components of Strategic Clinical Research Operational Planning

3:00 PM - 5:00 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 the technical tasks involved in clinical trial management will also be discussed.

May 26, 2016

Barnett International

Principal Investigator Oversight and the Appropriate Delegation of Tasks

12:00 PM - 1:30 PM Eastern

Principal Investigators (PIs) are required to provide adequate oversight of all clinical research activities at the site, whether the activity is conducted by the PI, by study team members, or by applicable third parties. Adequate oversight encompasses many activities and obligations, such as ensuring regulatory compliance, staff training, and subject medical care. In this web seminar, we will discuss the regulatory requirements and guidance regarding adequate investigator oversight and appropriate delegation of study tasks, review documentation requirements, and determine strategies for appropriate delegation of tasks.

May 27, 2016

Barnett International

Annual GCP Training Update: MHRA Inspection Findings for 2015

9:00 AM - 12:00 PM Eastern

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is one of the most exacting regulatory authorities in the world. Their specialist inspectors are highly trained to identify problems, deviations and discrepancies in clinical research. One of the best ways to learn about the inspectorate and its areas of focus is to consider the inspection findings which they have made. This web seminar will bring learners up-to-date on the current findings of the MHRA, which areas cause the regulator the most concern, and how they interpret the regulations and guidance to which they hold researchers accountable.

June 1, 2016

Barnett International

Regulatory Intelligence

12:00 PM - 1:30 PM Eastern

The constantly changing regulatory environment necessitates keeping abreast of current information from a variety of sources. Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc. There is more to RI than keeping up with the latest regulations and guidelines. Regulatory precedence, industry practices, regulatory agency opinions, and competitor information are just a few of the valuable sources of information that can help regulatory affairs professionals to develop successful regulatory strategies.

June

June 1, 2016

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.

June 2, 2016

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 3, 2016

Barnett International

TMF/eTMF Audit Strategies

9:30 AM - 11:00 AM Eastern

The process for managing the Trial Master File (TMF) has changed drastically in the last 10 years. Many organizations have moved to an electronic TMF (eTMF), yet some organizations still operate with a paper TMF or a hybrid of the two. A successful audit evaluates the completeness of the entire TMF. This web seminar will present a strategy for conducting a TMF audit that identifies gaps that have potential impact on the quality of the TMF. We will explore strategies for using the power of an eTMF to identify gaps that could result in inspection findings. The power of the TMF Reference Model in organizing the audit and identifying key artifacts that potentially impact Good Clinical Practice (GCP) compliance will also be discussed. Finally, we will examine strategies for the audit of a paper TMF as well as an eTMF, including critical files to review and how to spot trends in non-compliance.

June 2, 2016

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 3, 2016

Barnett International

eTMF Quality Oversight: A Risk-Based Approach

1:00 PM - 3:00 PM Eastern

When applied to electronic Trial Master File (eTMF) oversight, risk-based management is the combination of the potential of quality issues occurring and the impact these deficiencies may have on the integrity of the TMF and the overall Good Clinical Practice (GCP) impact on the study. The TMF is comprised of many records and documents, and a quality TMF is defined as a collection of records, which is complete, collected in a timely manner and comprised of quality records. In the past several years, regulatory agencies have been very clear in their expectation that a sponsor presents a quality TMF during an inspection. This web seminar will examine the concept of a risk-based approach to TMF management and oversight, and, its application to TMF oversight. Included are processes for conducting and documenting quality control (QC) activities that will ensure a high quality eTMF. Quality review findings can then drive the need for additional quality review activities, and by applying these concepts, the sponsor ensures TMF inspection readiness.

June 6, 2016

Barnett International

Bringing the Clinical Perspective into ISO 14971 Risk Management Discussions

1:00 PM - 2:30 PM Eastern

The clinical perspective is crucial to understanding risk and implementing effective decision-making in the risk management of medical devices. ISO 14971 is an international standard used by companies around the world as a basis for developing a risk management process for analyzing the risk associated with a medical device. Risk management for medical devices is typically handled by engineers responsible for designing and building a product and can have a tendency to focus on the mechanical risks instead of the clinical risks. A clinician needs to be available to discuss those risks in ways that are understandable to those outside of patient care, while understanding how the engineers discuss and view the device.

June 6, 2016

Barnett International

CMS-Medicare Coverage Analysis, Budgeting and Billing Compliance

1:00 PM - 2:30 PM Eastern

This web seminar is focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS-Medicare regulations for clinical trials remains a challenge for many clinical sites, sponsors and Contract Research Organizations (CROs). A risk-based approach requires not only a strategy but tools to define key indicators to measure specific risks. In this web seminar, learners will come away with strategies for covering true costs related to clinical research and how to distinguish them from routine care charges. Methodologies to avoid false claims and/or wrongful billing will also be presented.

June 7, 2016

Barnett International

Informed Consent Procedure: Lessons Learned from Inspection Findings

9:30 AM - 11:00 AM 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.

June 7, 2016

Barnett International

Data Management in the Electronic Data Capture Arena

10:30 AM - 2:00 PM Eastern

This program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process. Although the basic data management principles remain the same, for example good CRF design and ensuring the integrity of the data, the timelines and tasks surrounding today’s EDC are not interpreted exactly as the paper CRF process has previously dictated. The understanding of how the technology has changed the process will enable today’s Data Managers to move forward in the discipline and ensure their place as viable members of the clinical study team. As electronic data capture utilized as patient e-source or eCRF becomes more the routine, it is important that the CDM be fully aware of the capabilities of the EDC application in order to ensure a comprehensive data management component in the clinical trial conduct.

June 7, 2016

Barnett International

Ensuring Success Through Smarter Site Selection and Study Feasibility

1:00 PM - 2:30 PM 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 8, 2016

Barnett International

Advanced Good Clinical Practice: Practical Application and Implementation

10:30 AM - 2:00 PM Eastern

This course provides an advanced, in-depth review 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 program is designed for professionals with at least two years of experience in the clinical research industry.