CenterWatch

Webinars

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

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.

January 18 - March 22, 2017

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.

January 19, 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).

January 19, 2017

Barnett International

Quality Risk Management in Clinical Trials and Pharmacovigilance

12:00 PM - 1:30 PM Eastern

The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

This web seminar is designed to provide a strong conceptual foundation of the principles of quality risk management with a clear focus on the application of these principles. We will address applying QRM to support decision-making throughout the clinical trial management and pharmacovigilance process, allocating limited resources effectively to areas of high risk, and preparing the participant to become an active contributor towards risk-based quality management at his/her organization.

January 20, 2017

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.

January 23, 2017

Barnett International

Final ICH GCP E6 R2: Impact on Clinical Data Management

9:30 AM - 11:00 AM Eastern

Clinical Data Management plays a significant role in the performance of clinical trials. ICH GCP E6 R2 reinforces the requirements in regards to electronic systems and the Standard Operating Procedures (SOPs) that govern processes specific to these systems. In this web seminar, a review of these requirements as well as an examination of the components of quality management are covered. Further, the role that risk has on the overall conduct of clinical trials will be discussed, particularly since this concept will be the standard way forward (rather than an option). We will also review recommended approaches, industry standards/best practices to achieve compliance with the requirements.

January 23, 2017

Barnett International

Data Management: Key Regulations Impacting the Role of the Clinical Data Manager

1:00 PM - 2:30 PM Eastern

In conducting clinical research, there are some specific regulations that directly impact the discipline of Clinical Data Management (CDM). 21 CFR Part 11 includes mandatory regulations that govern clinical trials data. It requires a system in which electronic records and signatures are trustworthy, reliable, and secure; electronic signatures that are equivalent to paper records and handwritten signatures executed on paper; a system that discerns invalid or altered records; and signatures that are linked to an electronic record. The “Guidance for Industry—Computerized Systems Used in Clinical Trials,” builds on the importance of information inclusion when utilizing computerized systems. In addition, the recently finalized “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” specifically mentions the role that Clinical Data Management is expected to have in assisting in a risk-based monitoring approach. In this web seminar, we will explore the information in these regulations/guidances that will further the understanding of their impact on our current way of working.

January 24, 2017

Barnett International

Writing Clinical Study Protocols

12:00 PM - 3:00 PM Eastern

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

Over the course of a development plan, new protocols, amendments, and concept sheets will be needed. Protocols for Phases 1, 2, 3 and 4 require different writing approaches and you must know what the agency expects at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process.

January 24, 2017

Barnett International

Data Management Plan Creation: Content and Rationale

1:00 PM - 2:30 PM Eastern

A well-designed Data Management Plan (DMP) provides a detailed description of how to handle data under any foreseeable circumstances and establishes processes for how to deal with unplanned issues. The DMP is study specific, is considered a “living document,” and is subject to audit; therefore, it is important to understand the content requirements and rationale for its creation. In this web seminar, we will focus on the importance of the creation of a DMP and the expected content that this document should contain. Attendees will be provided with a sample template for review.

January 25, 2017

Barnett International

SDTM and CDASH: What's the Connection?

1:00 PM - 2:30 PM Eastern

Currently, the FDA requires that clinical trial data be electronically submitted in the Clinical Data Interchange Standards Consortium (CDISC) format for consideration for a new drug/biological approval. A significant element in this submission is the Study Data Tabulation Model (SDTM). This web seminar will examine the information defining the concepts of the SDTM as presented in the documentation Version 1.4. The purpose of data standards, benefits of applying these standards, and the relationship between datasets and records will be examined. The relationship between the standard for data collection instruments — also known as Clinical Data Acquisition Standards Harmonization (CDASH) standards — and the standard data format in which the data will be presented will also be discussed.

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.

January 26, 2017

Barnett International

Writing the Clinical Study Report

12:00 PM - 3:00 PM Eastern

The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This web seminar presents the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidances to follow for reference.

January 27, 2017

Barnett International

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

11:00 AM - 1:30 PM Eastern

On April 24, 2014, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release indicating that the definition of a critical Good Clinical Practice (GCP) inspection finding had been changed. It now includes, "Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations." Recently, the European Medicines Agency (EMA) released a reflection paper on GCP compliance in relation to TMFs. Currently, the FDA has not released regulatory guidance that directly addresses TMF expectations. FDA’s regulations are general and require that sponsors and investigators maintain adequate and accurate records of any clinical investigations that are carried out. This web seminar will examine these expectations and discuss recent regulatory findings. We will also discuss strategies for implementing corrective and preventive actions (CAPAs) that result in successful outcomes to regulatory findings associated with TMF inspections.

January 30, 2017

Barnett International

Protocol Deviations: Documenting, Managing, and Reporting

1:00 PM - 3:00 PM 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.

January 31, 2017

Barnett International

Introduction to Clinical Research

1:00 PM - 2:30 PM Eastern

Have you ever wondered what clinical trials are and how they are conducted? This web seminar is designed to answer those basic questions. We will look at how drugs progress from discovery to testing in humans, and learn what it takes to obtain approval to treat a disease or condition. We will discuss the similarities and differences between drug and medical device development. Finally, we will review how Good Clinical Practice (GCP) is applied to clinical trials around the world and how it is designed to protect clinical trial participants and ensure that the information obtained during a clinical trial is accurate and reliable.

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.

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