CenterWatch

Webinars

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

January

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 25 - March 29, 2017

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.

February

February 2, 2017

Barnett International

Strategies for Managing Difficult Clinical Research Sites

8:30 AM - 10:30 AM 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.

February 2, 2017

Barnett International

Use of Notes to File in Clinical Trial Essential Documentation

12:00 PM - 1:30 PM 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.

February 7, 2017

Barnett International

Cases in Advanced GCP: A Problem-Solving Practicum

9:00 AM - 12:00 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.

February 9, 2017

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.

February 10, 2017

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.

February 13, 2017

Barnett International

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

February 14, 2017

Barnett International

Adequate Sponsor Monitoring Systems in Anticipation of FDA Sponsor GCP Inspection

12:30 PM - 2:30 PM Easter

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.

February 15, 2017

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).

February 16, 2017

Barnett International

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance

1:00 PM - 3:00 PM Eastern

The most profound change in the updated ICH GCP E6 R2 is the new sponsor responsibility, Section 5.0, Quality Management. This section provides detail on implementing a system of quality management; critical process and data identification; risk identification; risk evaluation; risk control; risk communication; risk review; and risk reporting. Further, risk assessment and risk mitigation plans are required, regardless of whether Risk-Based Quality Management (RBQM) is being utilized by the sponsor. These requirements also address: Efficient clinical trial protocol design; data collection tools/procedures; and, collection of information that is essential to decision making. This web seminar takes an in-depth look at the updated guideline with respect to quality management, as well as the methodology of RBQM. How to apply these guidelines in a step-by-step process with strategies for effective implementation will be reviewed and an example provided.

February 16, 2017

Barnett International

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual

12:30 PM - 2:30 PM Eastern

As scrutiny of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research intensifies, companies are using their quality assurance resources to review internal (and vendor) systems to ensure compliance within a changing regulatory environment. A systematic application of the Compliance Program Guidance Manual (CPGM) permits identification of regulatory risks during qualification and in-process audits. This web seminar will review the FDA’s current guideline for conducting inspections and how to apply them to assess Quality Systems. Assessment of the SOPs that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will also be discussed.

February 16, 2017

Barnett International

30-Hour Clinical Project Management Fundamentals Certification Program

12:00 PM - 3:00 PM Eastern

In today’s outsourcing environment, the need for strong project management skills is greater than ever. This comprehensive hands-on 30-hour course is designed to provide the tools necessary to become a strong project manager in clinical research. Whether you are looking to become a clinical research project manager, you are already in an entry-level project manager role or you have become an “accidental” project manager by assignment, this program will provide you with project management skills development as well as the necessary tools and processes required to successfully manage projects in clinical research settings. The course includes an emphasis on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. Discussions, exercises, and tools are practically oriented with an emphasis given to practical application of key concepts and principles.

February 21, 2017

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.

February 21, 2017

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.”

February 22, 2017

Barnett International

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

11:00 AM - 12:30 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).

February 23, 2017

Barnett International

Use of Electronic Health Record Data in Clinical Investigations

9:30 AM - 11:30 AM Eastern

The FDA recognizes Electronic Health Records (EHRs) as data originators and in many cases, source documentation, which therefore subjects them to inspection. In its draft guidance for the Use of Electronic Health Record Data in Clinical Trials, the FDA expands upon prior guidance and provides its recommendations on the use of EHRs as source, and also outlines the responsibilities for ensuring quality and integrity of EHR data. As such, EHRs should be able to be obtained from multiple sources, they should be shareable, interoperable, and accessible to authorized parties. This web seminar will address recommendations for the use of EHRs as source data in clinical trials.

February 27, 2017

Barnett International

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies

12:00 PM - 1:30 PM Eastern

Non-compliance at research sites requires corrective action planning to address the deficiencies. The corrective action plan should include more than just the identification of the deficiency and intervention chosen to address the issue. Effective corrective action planning includes other important components that lead to promoting improved performance for future activities: Ultimately improved human subject protections and data integrity. Lack of these components can lead to repeated non-compliance and in some cases to rejection of corrective action plans by regulatory authorities.

February 28, 2017

Barnett International

CMS-Medicare Coverage Analysis, Budgeting and Billing Compliance

10:00 AM - 11:30 AM 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.

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