CenterWatch

Webinars

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

September

September 21, 2016

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).

September 21, 2016

Barnett International

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

2:00 PM - 3:30 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.

September 22, 2016

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 22, 2016

Barnett International

Case Narrative Writing for Reporting Adverse Events

9:30 AM - 11:00 AM Eastern

A narrative is a short document that is required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to briefly describe the events in the life of a patient. These narratives are required when a patient enrolled in a study, after taking the study medication or approved drugs (post-marketing), has discontinued the study because of an adverse event, had one or more serious adverse events, or died. FDA, EMA, and International Conference on Harmonization (ICH) guidance documents call for the submission of a study subject’s experience in narrative form for those who meet these specific criteria. This web seminar will provide a set of guidelines, instructions, and templates for the writing of clinical and post-marketing case narratives for reporting adverse events.

September 22, 2016

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 23, 2016

Barnett International

eTMF Quality Oversight: A Risk-Based Approach

9:30 AM - 11:30 AM 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.

September 23, 2016

Barnett International

TMF/eTMF Audit Strategies

1:00 PM - 2:30 PM 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.

September 26, 2016

Barnett International

Introduction to Data Management

9:30 AM - 11:30 AM 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.

September 26, 2016

Barnett International

Data Management in the Electronic Data Capture Arena

1:00 PM - 2:30 PM Eastern

This web seminar will explore the evolution of Clinical Data Management from a paper Case Report Form (CRF) process to the “real time” data review capable in the world of electronic data capture (EDC). We will review the specific regulations governing EDC and electronic signature requirements. Participants will examine the changing role of the Clinical Data Manager (CDM) as the technology drives the process, thereby allowing today’s CDM to move forward in the discipline and ensure their place as a viable member of the clinical study team. The EDC technology is enabling the data management component of clinical trial activities to advance and it is important that the CDM is aware of the capabilities the applications have to offer.

September 27, 2016

Barnett International

Data Quality in Clinical Trials: Rationale and Impact

12:30 PM - 2:30 PM Eastern

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

In this web seminar, we will explore the data quality definitions, processes involved in determination of quality, and the rationale utilized in ensuring data quality. It’s not about the individual data point anymore.

September 29 - December 8, 2016

Barnett International

30-Hour Clinical Research Auditing Certification Program

8:30 AM - 11:30 AM Eastern

The online 10-Week Clinical Research Auditing Certification Program provides a comprehensive introduction to clinical research and the job function of the Clinical Quality Assurance Auditor for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or transitioning into Good Clinical Practice (GCP) auditing. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the GCP auditor.

The resources required to take this online course are an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information. Prior to the start of the course, participants will receive comprehensivecourse materials. Come to class prepared to interact – you will be able to ask questions, provide feedback, and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

September 30, 2016

Barnett International

Phase I Study Management

12:00 PM - 1:30 PM Eastern

Because the early life of a compound is dependent on the data and analysis derived from Phase I Studies, it is imperative that these trials are managed and conducted with the highest quality and care. Therefore, well-honed project management skills that can address the unique issues associated with Phase I Studies are needed. This web seminar will examine the importance of Phase I Studies in drug development, the issues commonly associated with conducting a Phase I Study from a sponsor perspective and provide project management best practices specific to overseeing a Phase I Study.

October

October 3, 2016

Barnett International

Protocol Deviations: Documenting, Managing, and Reporting

9:00 AM - 11:00 AM 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.

There is a growing recognition within the industry as to the importance of appropriately managing protocol deviations. This web seminar provides tips and strategies to help participants anticipate, manage, and minimize the impact of protocol deviations. Investigators and Clinical Research Associates (CRAs) will learn how to appropriately document and report protocol deviations, with a focus on preventing recurrence. Internal study team members will learn how to implement a structured approach to managing significant deviations that impact subject safety and/or data integrity.

October 3, 2016

Barnett International

Final FDA Guidance: How to Complete the Form FDA 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.

October 4, 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.

October 5, 2016

Barnett International

ICH E6 GCP Proposed Revisions 2016 Review: Impact on Sites, Sponsors, and CROs

9:00 AM - 12:00 PM Eastern

For the first time in 20 years, the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E6 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.

October 5, 2016

Barnett International

Principal Investigator/Site GCP Compliance and Performance: What it Really Takes to Be GCP Compliant

1:00 PM - 2:30 PM Eastern

FDA inspections in today’s regulatory climate go beyond checking for a signed consent form and source data verification of the case report form. Today, inspections focus on how the cycle of quality is implemented for all aspects of the sponsor’s investigational plan. This includes Clinical Investigator supervision of the protocol’s execution in alignment with state statute/regulatory requirements. When there is an error/deficiency identified during the trial execution — what is done to address and correct this finding? And, if the same problem occurred again in the clinical trial do you know how to respond?In this web seminar, these questions will be further examined and examples will be reviewed on how sites implement ‘quality practices’ for trial execution that includes the health care standards/statutes for the site location.

October 5 - December 14, 2016

Barnett International

30-Hour Clinical Data Management On-Boarding Program

5:00 PM - 8:00 PM Eastern

The online 30-Hour Clinical Data Management On-Boarding Program is designed to provide a comprehensive and foundational study of the best practices which have been identified in the discipline of Clinical Data Management (CDM). From protocol review and identifying study design to the required data elements and the final steps at the milestone of database lock, we will identify and discuss crucial CDM processes. Information presented will give new Clinical Data Management personnel a robust view of all CDM processes. This on-boarding program will also assist individuals to refresh their knowledge if they are preparing to sit for the certification examination.

The resources required to take this online course are an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information. Prior to the start of the course, participants will receive comprehensive course materials. Come to class prepared to interact – you will be able to ask questions, provide feedback, and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

October 5 - December 14, 2016

Barnett International

10-Week CRA & CRC Beginner Program

6:00 PM - 9:00 PM Eastern

The online 10-Week CRA & CRC Beginner Program provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC) for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or career change into clinical research, but haven’t decided which job track to pursue. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the CRA and CRC. Upon completion, Barnett will provide resume assistance so that you can position yourself for entry into this market.

The resources required to take this online course are an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information. Prior to the start of the course, participants will receive comprehensive course materials. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

October 6, 2016

Barnett International

ABCs of GCP and the 13 Principles of ICH

9:30 AM - 11:00 AM 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.

October 6, 2016

Barnett International

The Fundamentals of Clinical Research Project Management

12:00 PM - 1:30 PM Eastern

Participants will explore the principles of project management and apply project management tools to ensure the success of their clinical research projects. Participants will learn to develop a project charter, a work breakdown structure, a risk assessment and contingency plan, a process improvement plan, as well as how to lead without authority. Each participant will leave the session with tools and checklists to apply to their projects.

October 6, 2016

Barnett International

Monitoring Visit Reports for Medical Device Studies

1:00 PM - 2:30 PM Eastern

In this web seminar, we will discuss how to write effective monitoring visit reports for medical device studies. Participants will learn the purpose for monitoring investigational sites and the importance of documenting the visit. We will examine the requirements for the documentation in the Code of Federal Regulations and International Conference on Harmonization Guidelines, and discuss how the report is used by various stakeholders. Tools will be provided to enable learners to scrutinize various sections of the report to better document what was accomplished on the visit. This documentation supports the adequate monitoring obligation expected by regulatory authorities.

October 6, 2016

Barnett International

FDA Medical Device Approval Process

3:00 PM - 4:30 PM Eastern

This web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH guidance — Investigational Device Exemption (IDE) and abbreviated IDE processes. This is done by reviewing sponsor and investigator obligations, along with the principles of Good Clinical Practice (GCP). Definitions used by sponsors and regulatory authorities for device development will be reviewed. Participants will become familiar with the regulatory decision-making process used by the FDA and learn to navigate the approval pathways to market.

October 7, 2016

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.

October 11, 2016

Barnett International

Medical Writing Fundamentals: How to Write Regulatory Documents

12:00 PM - 1:30 PM Eastern

Medical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve. This web seminar will give learners a broad overview of writing practices, formatting, working with tables and figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. In addition, real-life examples of strategies for generating a great document each time by understanding the what and why of the different documents will be presented.

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