CenterWatch

Webinars

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

August

August 29, 2016

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.”

August 29, 2016

Barnett International

ICH E-6 GCP Proposed Revisions 2016 Review: Impact on Sites, Sponsors, and CROs

9:00 AM - 11:30 AM Eastern

For the first time in 20 years, the International Conference for Harmonization (ICH) E-6 Good Clinical Practice (GCP) Guideline is being updated. The proposed revisions are intended to modernize and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. But, the proposed changes have resounding effects and impact on Sponsors and Investigators, requiring a complete and systematic analysis to ensure adherence to these proposed clinical trial standards. This web seminar not only informs learners of the proposed changes, but also provides information and techniques for a constructive and systematic approach in assessing organizational practices and designing any modifications.

August 30, 2016

Barnett International

Risk-Based Monitoring: The Data Management Connection

12:30 PM - 2:30 PM Eastern

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

August 30, 2016

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.

August 31, 2016

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.

September

September 9 - November 11, 2016

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 9 - November 11, 2016

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 9, 2016

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 web seminar will also include handouts and discussion of the TMF Reference Model.

September 12, 2016

Barnett International

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

9:30 AM - 11:00 AM Eastern

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

September 12, 2016

Barnett International

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

11:00 AM - 1:30 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 12, 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.

September 12, 2016

Barnett International

Managing CRAs to Improve Study Outcomes

2:00 PM - 4:30 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.

September 13, 2016

Barnett International

Conducting Clinical Trials Under ICH GCP

8:30 AM - 12:15 PM Eastern

This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining an ongoing relationship with the FDA will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for the clinical studies.

September 13, 2016

Barnett International

Introduction to Clinical Research

8:30 AM - 2:15 PM Eastern

This two-day course will cover topics designed to explain exactly what a clinical trial is and how clinical research is conducted. Since many clinical trials are often conducted in the European Union (EU), we will also include some key EU requirements. We will start by looking at the history of clinical trials to give you a better understanding of how and why current regulations were created to protect and inform clinical trial participants as well as ensure the public that the information obtained from those trials is accurate and reliable. Then we will look at the process of drug and device development from discovery to approval. We will introduce you to the protocol which is the blue print for any clinical trial and explain what an informed consent is and why it is so important. In addition to these key trial documents, we will also review other important documents that are used in clinical trials. Finally, we will provide you with resources that will enable you to stay informed about topics and regulations regarding clinical trials in the U.S. and in the European Union.

September 13, 2016

Barnett International

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

9:30 AM - 11:00 AM 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.

September 13, 2016

Barnett International

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

12:30 PM - 2:30 PM 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 14, 2016

Barnett International

Advanced Good Clinical Practice: Practical Application and Implementation

10:30 AM - 2:15 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.

September 14, 2016

Barnett International

Approaches to Address Challenges in Vendor Management

12:00 PM - 2:30 PM Eastern

Outsourcing in clinical development continues to grow and so do the challenges of ensuring quality outcomes. Managing a vendor vs. micro-managing a vendor will be discussed with some practices to improve the relationship. Recommendations for sponsor oversight practices are discussed with a review of helpful tools.

September 14, 2016

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 14, 2016

Barnett International

Implications of the FDA Guidance for a Risk-Based Approach to Monitoring and the EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials

3:00 PM - 4:30 PM Eastern

FDA and EMA have communicated their expectations for trial oversight/monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring and the EMA Reflection Paper on risk based quality management in clinical trials both of which will be reviewed in this web seminar, as well as, industry think tank contributions.

September 14, 2016

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 15, 2016

Barnett International

ICH E-6 GCP Proposed Revisions 2016 Review: Impact on Sites, Sponsors, and CROs

12:00 PM - 3:00 PM Eastern

For the first time in 20 years, the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E-6 Guideline is being updated. The proposed revisions are intended to modernize and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. But, the proposed changes have resounding effects and impact on sponsors/CROs and investigators, requiring a complete and systematic analysis to ensure adherence to these proposed clinical trial standards. This web seminar reviews the proposed changes, the varied, select, clinical research practices impacted and select approaches to use when addressing the new requirements (e.g., standards, processes, procedures, training, documentation) that serve both as the starting point for an organization’s gap analysis, and, the subsequent re-design of work practices for compliance with the ICH GCP E6 R2 proposed revisions. In addition, an overview of key points to include in an organization’s project plan/implementation plan for the proposed revisions will be presented with time allocated for Q & A and discussion.

BONUS reference slides are provided on: Organizational quality management systems, quality, quality in the clinical trial context, risk definition, risk management framework benchmark (ISO 31000 model), and a list of industry think tanks that provide free information, training materials, methods and tools for the industry’s use since, due to time limitations, these topics are not able to be addressed. Barnett does provide training on these topics as distinct courses that are provided on-site or via web seminar that allows for a confidential discussion on your specific needs during the training.

September 15, 2016

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.

September 16, 2016

Barnett International

Centralized TMF Management: The CRO Sponsor Partnership

9:30 AM - 11:00 AM 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. Both partners must understand the activities of each other to ensure that all artifacts within the TMF have been collected and are available within the TMF. A key tool in centralized TMF Management is the TMF Study Map. We will explore the process of developing and managing the TMF Study Map in tracking the content of the TMF during the active phase of the study and at completion. Use of a TMF Plan by the sponsor and the CRO will also be discussed.

September 16, 2016

Barnett International

Building Relationships with Clinical Research Sites

11:00 AM - 12:30 PM Eastern

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