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.

March

March 3, 2017

Barnett International

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.

March 6, 2017

Barnett International

Monitoring Oncology Clinical Trials

12:30 PM - 2:30 PM Eastern

This web seminar will provide attendees with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed.

March 9, 2017

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

12:00 PM - 3:00 PM 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.

March 9, 2017

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.

March 10 - May 19, 2017

Barnett International

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

12:00 PM - 3:00 PM 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.

March 10, 2017

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.

March 13, 2017

Barnett International

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs

12:00 PM - 1:30 PM Eastern

This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.

March 14, 2017

Barnett International

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

1:00 PM - 2:30 PM 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.

March 14, 2017

Barnett International

FDA Drug Approval Process

12:30 PM - 3:30 PM Eastern

This web seminar provides an overview of what is required to take a new drug from research to market. We will begin by reviewing the contents of an IND, and then follow the process of an IND submission. From there, the contents and approval process of an NDA submission will be discussed. This web seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and help attendees become familiar with the regulatory landscape in which INDs and NDAs are developed and approved.

March 15, 2017

Barnett International

Establishing a Risk Management Framework for Clinical Trial Conduct and Oversight

11:00 AM - 12:30 PM Eastern

As many organizations move to, or contemplate, a risk-based approach to trial conduct and quality management, the published regulatory agency documents and industry think tank publications fall short in providing sponsors, CROs, and clinical vendors the framework—a comprehensive, systematic, structured approach to implementing risk management. This web seminar will provide an overview of a risk management reference model for use that has been adopted by other industries and is referenced in the FDA Guidance of 2013, “Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring.”

March 16, 2017

Barnett International

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites

12:00 PM - 2:30 PM Eastern

For the first time in 20 years, the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E6 Guideline has been significantly updated. The revisions are intended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. But, the changes have resounding effects on the conduct of clinical research by sponsors/CROs and investigators.

March 21, 2017

Barnett International

Preparation, Management, and Response to Inspections and Audits

10:00 AM - 2:00 PM Eastern

Faced with an impending audit or inspection, how do you prepare? If inspection results in findings, do you have the skills and tools to best respond to these issues to avoid further actions? This web seminar will provide an overview of what to expect and how to prepare for an audit or inspection. Real case scenarios in a workshop format will be used to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors. Steps for preparation, on-site auditing and follow-up actions will be explained. Interactive exercises will be incorporated utilizing FDA Warning Letters. Participants will learn how to perform root cause analysis (RCA) and prepare corrective and preventive actions (CAPAs).

March 22, 2017

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.

March 23, 2017

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.

March 24, 2017

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.

March 27, 2017

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.

March 28, 2017

Barnett International

Auditor Emotional Intelligence

1:00 PM - 3:00 PM Eastern

Audits are often viewed as transactional and factual – and rightly so! They are transactional (a process carried out) and must be factual, devoid of as much personal bias and emotion as possible. However, the power of advanced soft skills in enhancing both the transactional and factual aspects of an audit cannot be underestimated. We have all heard stories of painful audits with auditors who possessed little to no soft skills. The use of appropriate, advanced soft skills serves to reinforce a culture of quality with the auditee. The most important soft skill a quality professional can possess is emotional intelligence.

March 29, 2017

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).

March 30, 2017

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.

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