CenterWatch

Webinars

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

December

December 6, 2016

Barnett International

Cases in Advanced GCP: A Problem-Solving Practicum

12:00 PM - 3:00 PM Eastern

This application-based web seminar covers advanced concepts and challenges encountered in the application of Good Clinical Practice (GCP). During this highly interactive course, participants will review and discuss cases that include GCP challenges in topic areas such as IRB/IEC approval, informed consent, drug accountability and reconciliation, SUSAR submissions, communications with ethics committees and health authorities, as well as the management of investigational product. Cases are based on actual industry examples, and participants are expected to solve cases by applying Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) principles, which are briefly reviewed.

December 7, 2016

Barnett International

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 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.

December 7, 2016

Barnett International

Quality by Design in Clinical Research: Is This Only for the Protocol?

1:00 PM - 2:30 PM Eastern

Over the past few years, Quality by Design (QbD) for clinical trials has been a focus for protocol development and execution. However, even though it is increasingly expected of the industry by regulatory agencies, translating this QbD approach into “building in quality for the business” is rarely shared for the “how do I do this?” This web seminar will de-code and translate QbD and quality for the research enterprise with examples that will solidify the concepts and framework presented for use within any organization. We will discuss the critical first step of defining quality; how to simplify QbD; how QbD and Quality Management Systems (QMS) relate to each other; determining whether your organization has these in place; what the best QbD principles and methods are; how to go beyond plans and create checklists for quality; and, finally, strategies for effective implementation.

Case Study: QbD for a CRA Study Management Plan
Job Aid: QbD Worksheet

December 7, 2016

Barnett International

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

3:00 PM - 6:00 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.

December 9, 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.

December 12, 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.

December 13, 2016

Barnett International

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques

9:00 AM - 12:00 PM Eastern

In recent years, the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have increased the frequency and reach of their inspections. The outcome of the inspection can determine whether a product will be granted a marketing authorization in Europe or the UK, and good preparation will enable the research to be shown in the most favorable light. This web seminar will help learners to know how best to prepare their organizations for inspections by the EMA and MHRA inspectorates, to know what the inspectors are looking for, to understand what to expect during the inspection and to learn from real inspection experiences.

December 14, 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.

December 15, 2016

Barnett International

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

12:00 PM - 3:00 PM Eastern

Negotiating study contracts and budgets is critical for the future success of the clinical research site. This web seminar provides strategic skills and best practices for contract negotiations and budget development. Learners will also review and practice the art of negotiation.

December 19, 2016

Barnett International

Use of Notes to File in Clinical Trial Essential Documentation

8:30 AM - 10:00 AM Eastern

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

December 19, 2016

Barnett International

Strategies for Managing Difficult Clinical Research Sites

12:00 PM - 2:00 PM Eastern

Many Clinical Research Associates (CRAs) ask: “How do I best handle a difficult site?” In this web seminar the question is addressed through real life case scenarios that deal with the different kinds of “difficult” sites, for example: The overwhelmed site, the unmotivated site, the passive aggressive site, the research naïve site. All of these types of behaviors at sites can lead to poor performance that does not respond to typical CRA action item management. Hear ideas on how to successfully work with the difficult site to promote efficiency and positive study outcomes that include helpful job aids, soft skill coaching, and diagnostic techniques to help improve approaches to interventions and management of the “difficult” site.

December 20, 2016

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.

December 20, 2016

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

12:00 PM - 2:00 PM Eastern

Investigator Initiated 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.

December 21, 2016

Barnett International

Introduction to Statistics for Non-Statisticians

12:00 PM - 3:00 PM Eastern

This web seminar is intended for clinical research professionals who have little or no background in statistics. In it, we will cover the basic statistical concepts needed to understand the roles statistics play in health research. The topics addressed include types of variables, levels of measurement, descriptive statistics, precision, confidence intervals, and an introduction to hypothesis testing. This web seminar is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Emphasis will be placed on understanding statistical information and not on calculations or statistical formulae.

December 21, 2016

Barnett International

Case Narrative Writing for Reporting Adverse Events

1:00 PM - 2:30 PM 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.

January

January 11, 2017

Barnett International

Final ICH GCP E6 R2: Sponsor Quality Management – Risk-Based/Risk Management Requirements and Approaches for Compliance

9:00 AM - 11:00 AM Eastern

ICH GCP E6 R2 provides significant detail on implementing a system of quality management with a focus on a risk-based/risk management approach for the trial, also referred to as Risk-Based Quality Management. This web seminar reviews this new sponsor requirement and describes the clinical quality management system (cQMS) that should be used to oversee quality during the design, conduct, recording, evaluation, reporting and archiving phases – notably the lifecycle of the clinical trial. Additionally, cQMS industry benchmarks, standards and practices will also be discussed.

January 11, 2017

Barnett International

Final ICH GCP E6 R2: Changes Impacting Site and IND Holders (Sponsors-Investigators and Institutions)

1:00 PM - 3:00 PM Eastern

The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This web seminar explores the changes in detail to promote a better understanding of how they impact clinical trials. Practical information and a systematic approach in assessing organizational SOPs, processes and practices as well as designing modifications to assist with implementation will also be provided.

January 12 - March 30, 2017

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.

January 12, 2017

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.

January 12, 2017

Barnett International

ABCs of GCP and the 13 Principles of ICH GCP E6

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.

January 13, 2017

Barnett International

Trial Master Files: Why They Are Important and How to Organize Them Workshop

9:00 AM - 4:00 PM Eastern

The Trial Master File is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations for a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50 that, “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.” The European Directive 2005/28/EC states that, “the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.” ICH GCP, Section 8.1 defines these essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. They are all also eligible for inspection by the regulatory authorities at any time during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics and devices. It is, therefore, paramount that these documents are filed in a way to make them immediately accessible for use by the study team and for regulatory inspection. This module will provide some practical solutions to meet these challenges.

Participants will review the content that is required of a Trial Master File for drugs and devices for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor.

The activities of set-up, maintenance, and quality assurance will be discussed, as well as common deficiencies and challenges. The need for an effective Standard Operating Procedure (SOP) will also be examined.

In today’s regulatory environment, the files must be “audit ready” at all times. Regulatory authorities may contact the sponsor and request a particular document be provided to them for inspection. Therefore, the timely filing and organization of these documents is of utmost importance. There needs to be a consistent system employed such that documents can be located and provided for study team use as well as regulatory inspection in a timely manner.

January 16, 2017

Barnett International

Source Documentation: What is Adequate & Accurate?

1:00 PM - 3:00 PM Eastern

Lack of adequate and/or accurate source documentation has been noted as a common deficiency in inspection findings of Clinical Investigators. There is significant variability between stakeholder requirements regarding source documentation per study, including sponsor to sponsor, sponsor to site, etc. The creation and use of source document worksheets and the use of the Case Report Form (CRF) as the original source have raised a lot of industry debate. These issues and more regarding adequate and accurate source documentation to meet the requirements of regulatory agencies essential documentation standards will be presented and discussed.

January 17, 2017

Barnett International

Monitoring Plan Development

1:00 PM - 3:00 PM Eastern

Although monitoring plans are not defined or specifically required by FDA regulations or the ICH Guideline for Good Clinical Practice, both organizations endorse the use of this tool in a Quality Systems management approach to clinical research. The traditional approach to monitoring plan development has relied upon reinforcing SOP-mandated monitoring activities with little focus on project and/or protocol-specific monitoring needs. This web seminar provides participants with concepts and templates to set up a monitoring plan that supports unique project risks and links to valuable data regarding investigative site and Clinical Research Associate (CRA) performance. Suggestions for development of monitoring plans for a risk-based approach to monitoring are also provided in this session.

January 18, 2017

Barnett International

Re-Engineering the RFP and Bid Defense Meeting to Effectively Manage Risk and Quality

1:00 PM - 2:30 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.

January 18, 2017

Barnett International

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

3:00 PM - 4:30 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.

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