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Webinars

July | August

June 6 - August 22, 2014 (Fridays)

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.

July

July 29, 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.

July 30, 2014

Barnett International

Developing Clinical Study Budgets for Sponsors

12:30 PM - 2:30 PM Eastern

In an environment where studies are becoming more challenging to execute and taking more resources and time than anticipated, it is key to develop a solid and flexible budget to allow for study execution challenges. In developing a budget it is critical to address all standard line items such as reimbursement for procedures, but how can the oversight and follow-up time be accurately calculated? How does Fair Market Value (FMV) criteria factor into budget development? What questions should be asked to determine additional, unwritten, study expectations? What are some key elements leading to delayed budget negotiation and approval? This web seminar will address the fundamentals of budget development and considerations for ensuring that budgets are developed fairly to ensure that sites are appropriately reimbursed for study expectations.

July 30, 2014

Barnett International

Strategies for Conducting Vendor Audits

1:00 PM - 2:30 PM Eastern

Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Vendors play a key role in accomplishing these mandates and it is the sponsor’s responsibility to ensure their vendors meet all regulatory specifications for the supplied materials, equipment, and/or services. During this web seminar, we will discuss types of vendor audits, various methods/media to conduct vendor audits, planning for the audit, and follow-up to vendor audits.

July 31, 2014

Barnett International

Risk-Proof Your Sites: Monitoring Strategies for Managing Risks

9:00 AM - 11:00 AM Eastern

The concepts and processes of risk management are well known and often used in clinical research project management. Yet, few clinical research monitors realize the value of applying these activities to site management. This web seminar starts with an overview of risk assessment and management. The learner is then guided through the application of these techniques through all phases of study conduct: Site selection and initiation, routine monitoring, and site close-out. The course focuses on identification of site strengths and weaknesses and implementing strategies to address weaknesses before they lead to deviations or noncompliance.

July 31, 2014

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).

August

August 1, 2014

Barnett International

Monitoring Phase I Clinical Trials

12:00 PM - 2:00 PM Eastern

Phase I trials require an additional monitoring skill set. The Clinical Research Associate (CRA) assessment focus changes in many monitoring practices, from the Informed Consent Form to data review of PK sampling. Most CRA trainings do not test or provide practicum for the unique focus of a Phase I trial. This web seminar will identify the differences in skills and review certain components of this type of monitoring. Tools to support the activities will be presented, as well as case studies to apply certain concepts.

August 4, 2014

Barnett International

Leading Teams in a Changing Clinical Research Environment

9:30 AM - 11:30 AM Eastern

Teams have become much more complex in the past 10 years. In the past, a team would be comprised of similar individuals in the same location driving on a fairly stable course towards its objectives. These tenets are no longer true. Trends are driving the need for more flexible, highly skilled teams.

August 4, 2014

Barnett International

The GCPs of Essential Documents

1:00 PM - 2:30 PM Eastern

Understanding the big picture of how essential study documents impact the approval and ethics of a clinical research trial often gets overlooked in the rush of document collection and requests. The foundation of this web seminar is the site study file, what the documents are, and why they are important as related to ICH GCP E6 Essential Documents and 21 CFR 50, 54, 56 and 312. This web seminar will also provide a reference point for why the paperwork is so critical within the process of a study.

August 5, 2014

Barnett International

CRO Partnership Management

9:30 AM - 11:00 AM Eastern

In an environment where we are outsourcing multiple tasks, it is valuable to understand the dynamics of relationship building and the application of practical management. Extensive knowledge and skill are required to manage large teams, especially when the majority of the team functions outside of your organization. This web seminar provides an overview of Contract Research Organization (CRO) partnership building, management, application of root cause analysis (RCA) and strategies for problem solving.

August 5, 2014

Barnett International

Navigating the Unusual Consent Process

1:00 PM - 2:30 PM Eastern

Informed consent is a challenging process with any clinical trial subject; ensuring understanding and agreement with a form detailing a medical study and filled with legal jargon can be time consuming and stressful. In addition, when we are faced with unusual consent situations, and the rules are not readily available, we run into questions regarding ethics and regulatory ramifications. This web seminar is designed to address some of the more unusual consent situations and address the regulations, guidances, and input from ethics committees on developing the consent document and managing the informed consent process. Considerations for use of the short form, legally authorized representatives, exceptions to the standard consent process, pediatric assent, and challenges with impaired subjects will be discussed.

August 11, 2014

Barnett International

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

9:30 AM - 11:00 AM 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.

August 11, 2014

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.

August 12, 2014

Barnett International

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

9:30 AM - 11:30 AM 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).

August 12, 2014

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.

August 12, 2014

Barnett International

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance

12:30 PM - 2:30 PM Eastern

As the use of electronic source documentation (eSource) increases, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, the FDA issued a draft guidance regarding the use of electronic source documentation, providing direction to sponsors, CROs, data management centers, and Clinical Investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. After a comment period, a new draft guidance was released in late 2012 focusing on identification and specification of authorized source data originators, the creation of data element identifiers to facilitate examination of the data audit trail, capture of source data into the eCRF, and Investigator responsibilities with respect to reviewing and retaining electronic data. This web seminar will review how the requirements for paper source documentation translate to the electronic source document as well as examine realworld examples of the FDA’s review of eSource.

August 13, 2014

Barnett International

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

1:00 PM - 2:30 PM Eastern

The regulations require that sponsors ensure the selection of qualified monitors and the proper monitoring of clinical investigations. However, sponsors are frequently cited by the FDA for failure to meet those requirements. These regulatory communications note that although monitors might have identified issues, they did not appreciate the significance of those findings. As a result, opportunities to promptly secure compliance might be missed.

August 14, 2014

Barnett International

Case Report Form Design, Strategy, and Standards Workshop

9:00 AM - 4:00 PM Eastern

According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): "…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention."

August 14, 2014

Barnett International

Understanding Global Requirements for Trial Registration and Disclosure of Results

9:30 AM - 11:00 AM Eastern

Since its inception in 2000, the clinical trials registry has served as a source of information for the general public, academia, and industry. In 2007, the U.S. Congress passed FDAAA, which required additional trial registration information, more types of trials to be registered, and the submission of summary results for applicable clinical trials. The following year, sponsors and Principal Investigators began submitting the results of clinical studies on ClinicalTrials.gov. Although submission of Adverse Event information was optional when the results database was released, it became required in September 2009.

August 14, 2014

Barnett International

Risk-Based Auditing: Effective Compliance Strategies

12:30 PM - 2:30 PM Eastern

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).

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.

August 15, 2014

Barnett International

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada

12:30 PM - 2:30 PM Eastern

As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. Regulatory agencies’ recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventive action plans are developed to secure compliance. This web seminar will examine the trends in recent regulatory communication and open discussion for review of acceptable versus unacceptable responses.

August 18, 2014

Barnett International

Data Management in the Electronic Data Capture Arena

9:30 AM - 11:00 AM Eastern

This web seminar will explore the evolution of Clinical Data Management from a paper Case Report Form (CRF) process to the “real time” data review capable in the world of electronic data capture (EDC). We will review the specific regulations governing EDC and electronic signature requirements. Participants will examine the changing role of the Clinical Data Manager (CDM) as the technology drives the process, thereby allowing today’s CDM to move forward in the discipline and ensure their place as a viable member of the clinical study team. The EDC technology is enabling the data management component of clinical trial activities to advance and it is important that the CDM is aware of the capabilities the applications have to offer.

August 18, 2014

Barnett International

ABCs of Clinical Research for Clinical Administrative Support Staff

12:30 PM - 3:00 PM 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.

August 19, 2014

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.

August 21, 2014

Barnett International

Case Report Form Design, Strategy, and Standards

9:30 AM - 11:30 AM 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.

August 22, 2014

Barnett International

Social Media in Clinical Research: Effective, Innovative, and Compliant Applications

1:00 PM - 3:00 PM Eastern

The use of social media in all aspects of the research enterprise has grown exponentially. Researchers from across disciplines and institutional types are finding innovative ways to facilitate research, from online recruitment mechanisms to informed consent portals. Concurrently, researchers and their ethics review boards have been grappling with ethical and regulatory challenges as technologies continue to change rapidly, resulting in a flurry of new questions: Can I use social media to find “lost to follow up” subjects? Can I join a support group to find subjects? What regulations exist around the use of social media? Just what is public information? This web seminar will provide an overview of Institutional Review Board (IRB) considerations of social media in research, including those major ethical challenges and data security issues that may arise with the use of social media for recruitment, consent processes, data collection, and data dissemination.