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Webinars

August | September | October |

August

August 14 - October 16, 2014

Barnett International

30-Hour Clinical Project Management Fundamentals Certificate Program

5:00 PM - 8:00 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.

August 15 - October 24, 2014

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.

September

September 5, 2014 - November 7, 2014

Barnett International

10-Week Clinical Research Associate (CRA) On-Boarding Program

8:30 AM - 11:30 AM Eastern

The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA. The course provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biologic, and device trials. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both U.S. and global audiences. Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, and scenario review, as well as application-based homework assignments.

September 17, 2014

Barnett International

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components

12:00 PM - 2:30 PM Eastern

Current societal events have influenced the increased use of an electronic medical record (EMR), one being the promotion of a national electronic medical record. More and more research sites are using an EMR for all or part of their case histories for research subjects. The industry has defined the characteristics that source documents in any form must include, and 21 CFR Part 11 includes standards for electronic source data. Challenges in monitoring the original source document have been growing and unaddressed in many situations. The FDA’s final guidance document for 21 CFR Part 11 supports certain characteristics that EMRs should include, but many site electronic records do not meet the requirements. This web seminar will discuss assessment of EMRs, ideal monitoring vs. contingency planning, and risk management.

September 18, 2014

Barnett International

Risk-Based Site Monitoring

9:00 AM - 10:30 AM 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 18, 2014

Barnett International

State Laws Governing Clinical Trial Regulatory Compliance

9:30 AM - 11:00 AM Eastern

Although many clinical trial sponsors and investigators focus primarily on FDA regulations related to the conduct and design of clinical trials, their failure to comply with state laws and regulations may expose sponsors, investigators, IRBs, institutions, or individuals may call into question the potential integrity of clinical data. Today’s U.S.-based clinical trials must meet not just federal requirements, but an increasingly complex array of state-specific requirements, many of which are critical and foundational to clinical studies. The capacity to consent to experimental therapy has its foundational basis and is governed by state law.

September 18, 2014

Barnett International

Approaches to Address Challenges in Vendor Management

12:00 PM - 2:30 PM Eastern

Outsourcing in clinical development continues to grow and so do the challenges of ensuring quality outcomes. Managing a vendor vs. micro-managing a vendor will be discussed with some practices to improve the relationship. Recommendations for sponsor oversight practices are discussed with a review of helpful tools.

September 22, 2014

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.

September 22, 2014

Barnett International

Source Documentation: What is Adequate & Accurate

9:30 AM - 11:30 AM 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.

September 22, 2014

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 protocolspecific 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.

September 23, 2014

Barnett International

The FDA Medical Device Pre-Submission Package and FDA Meetings

12:30 PM - 3:30 PM Eastern

The FDA Medical Device Pre-Submission program is intended for companies to use in order to obtain FDA feedback on future applications prior to their submission. The applications include Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs), and Premarket Notifications (510(k)s). This program allows the FDA to provide advice to applicants who are developing clinical and nonclinical testing protocols which are submitted with the company’s application. The program also allows the FDA to work with applicants from medical device concept to market. This web seminar will provide learners with information about how to prepare for and conduct various FDA meetings, specifically addressing the types of applications that companies file with the FDA.

September 23, 2014

Barnett International

CRA Current Practice Update: Impact of the FDA BIMO Program

1:00 PM - 3:00 PM Eastern

The FDA announced in 2006 an initiative to modernize the regulation of clinical trials, including the BIMO inspections program. This includes conducting inspections and other assessments earlier in the development of a potential product to build quality into the clinical trial upfront rather than assessing it at trial completion. From this initiative, the FDA has generated new guidance and regulation that directly affect the performance of the sponsor monitor. The initiative is a dynamic process and this web seminar tracks the updates that directly affect monitoring. Examples of how to implement the agency requirements and recommendations into current practices and specific projects are also covered.

September 24, 2014

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.

September 24, 2014

Barnett International

Strategies for Protocol Operationalization and Adherence

1:00 PM - 2:30 PM Eastern

Protocols are rising in complexity, length, and numbers of procedures. Protocol training is trending toward webinars vs. live meetings where questions are more limited and less likely to be asked. With more to do and less time and instruction, taking on new and challenging protocols can be daunting. This web seminar will focus on some introductory steps to taking a protocol apart and making it operational and executable without deviations at a site. Topics to be addressed include how to get the most out of the initial protocol review, understanding and putting into practice the patient flow, and how to ensure protocol adherence in a busy, ever-changing site environment.

September 24, 2014

Barnett International

Principal Investigator Oversight and the Appropriate Delegation of Tasks

3:00 PM - 4:30 PM Eastern

Principal Investigators (PIs) are required to provide adequate oversight of all clinical research activities at the site, whether the activity is conducted by the PI, by study team members, or by applicable third parties. Adequate oversight encompasses many activities and obligations, such as ensuring regulatory compliance, staff training, and subject medical care. In this web seminar, we will discuss the regulatory requirements and guidance regarding adequate investigator oversight and appropriate delegation of study tasks, review documentation requirements, and determine strategies for appropriate delegation of tasks.

September 25, 2014

Barnett International

Best Practices for Hosting a Client Audit

9:30 AM - 11:00 AM Eastern

Hosting a client audit can be a stressful experience for all involved when there is a lack of preparation, communication, and understanding of expectations for the audit. As the audit host, there are ways to gain a sense of control in your work environment while providing the auditor(s) with the best audit experience possible. Meeting their audit needs while reducing unnecessary lost work time and increased stress by the company being audited can be accomplished by way of audit preparation efficiencies. In this web seminar, we will discuss preparation techniques for hosting a client audit including room staging, strategies for responding to audit requests, and the audit follow-up process. During the course, learners will walk thru the process for hosting a client audit, discuss the various roles and responsibilities, as well as review strategies for successful audit results.

September 25, 2014

Barnett International

Regulatory 101: Navigating the Background, Laws, and Pertinent Regulations

12:00 PM - 1:30 PM Eastern

Complex regulations govern the development, manufacture, and commercialization of biomedical products. This web seminar will help participants understand the U.S. regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, biologicals, and medical device products. Participants will gain high-level knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, and post-marketing requirements. This is an important course both for those entering the biomedical profession and for those already in the profession to learn more about the laws governing this industry.

September 26, 2014

Barnett International

Strategies for Developing Effective Training and Facilitation Skills in Clinical Research

9:30 AM - 11:00 AM Eastern

In clinical research, there is an on-going need to conduct training whether it is at the onset of a study, due to a change in staff or new staff, as a result of an amendment, or because of an identified noncompliance issue during a study. If our goal in training is to pass on knowledge and to ask learners to apply that information, we need to consider our approach in how to make this happen. It is important to consider how essential every communication is within research; the information shared can have a huge impact on study timelines, data integrity, and compliance.

September 29, 2014

Barnett International

Introduction to Statistics for Non-Statisticians

8:30 AM - 11:30 AM 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 29, 2014

Barnett International

Good Clinical Practice: Practical Application and Implementation

9:30 AM - 11:30 AM 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.

September 29, 2014

Barnett International

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

12:30 PM - 2:30 PM Eastern

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

September 29, 2014

Barnett International

CRC Role/Responsibilities Training

1:00 PM - 3:00 PM Eastern

The Clinical Research Coordinator (CRC) can be a key liaison between the investigator, subject, Institutional Review Board (IRB), and sponsor. The CRC assists the investigator to ensure that the clinical trial is successfully implemented and completed. This web seminar presents the core skills and activities performed by the CRC and the documentation requirements that come along with clinical trials.

September 30, 2014

Barnett International

Fraud in Clinical Research: An Overview

12:30 PM - 2:30 PM Eastern

Fraudulent activities in clinical research undermine clinical research professionals’ ability to meet their obligations for ensuring credible data is obtained from protected participants. This web seminar provides an overview of fraud in clinical research and its potential impact on the industry and the public’s health.

October

October 1, 2014

Barnett International

Adequate Sponsor Monitoring Systems in Anticipation of FDA Sponsor GCP Inspection

12:30 PM - 2:30 PM Eastern

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.

October 2, 2014

Barnett International

Critical Decision Points in Design and Conduct of Patient Registries

12:00 PM - 1:30 PM Eastern

Patient registries are based on principles of observational research and offer remarkable flexibility in design and applications. They have demonstrated value in both the biopharmaceutical and the medical device arenas. Patient registries are appealing to physician investigators, and can serve as a centerpiece or as an adjunct to a product’s late-phase scientific and promotional strategy.

October 2, 2014

Barnett International

Quality Systems: A Controlled Approach to GCP Compliance

12:30 PM - 2:30 PM Eastern

A Quality Systems approach to establishing and maintaining regulatory compliance allows sponsors to better leverage their resources and Clinical Investigators to meet their obligations for clinical research oversight. This web seminar will review the elements of a Quality System at the Clinical Investigator site and how it functions to proactively control site-level noncompliance.

October 3, 2014

Barnett International

Data Safety Monitoring Boards (DSMBs) for Clinical Trials

9:30 AM - 11:00 AM Eastern

This web seminar will describe what a Data Safety Monitoring Board (DSMB) — also known as a Data Monitoring Committee (DMC)—is, and how it’s constituted according to FDA and European Medicines Agency (EMA) requirements. We’ll cover the selection of the members and their duties and responsibilities, as well as when a DSMB/DMC is and is not needed. We’ll also take a look at the contents of a DSMB/DMC charter. Interim analyses (with and without statistical analyses) will be discussed, as well as looking at benefits and costs. DSMB/DMC actions and recommendations in terms of study change or termination will be reviewed. Problems, ethical issues, and potential conflict will be discussed, along with strategies for resolving them. Learners will come away with tips, war stories, and practical advice on making DSMB/DMCs work.

October 3, 2014

Barnett International

FDA Review of Integrated Safety Summaries (ISS) During the NDA Review

12:00 PM - 1:30 PM Eastern

The FDA has a detailed and complex set of instructions for its medical reviewers assigned to review the clinical (and non-clinical) safety sections of an NDA. They explain what is important and what is not important; what to look for; what to disbelieve and take with a grain of salt; and how to put together an analysis of the clinical safety section of an NDA submission. These instructions are complicated and “eye-opening” for the industry and those who prepare NDAs. All companies should be aware of the “ground rules” and what the FDA is expecting to see from companies. Some of the areas that companies labor over are systematically given little weight by the reviewer or even ignored. In this web seminar, we will go over the instructions the FDA follows in their safety reviews and assist learners to better handle safety analyses and NDA preparation.