CenterWatch
CenterWatch
CenterWatch
CenterWatch
CenterWatch

Webinars

July | August |

July

July 16, 2015

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.

July 16, 2015

Barnett International

The Fundamentals of Clinical Research Project Management

12:00 PM - 1:30 PM Eastern

Participants will explore the principles of project management and apply project management tools to ensure the success of their clinical research projects. Participants will learn to develop a project charter, a work breakdown structure, a risk assessment and contingency plan, a process improvement plan, as well as how to lead without authority. Each participant will leave the session with tools and checklists to apply to their projects.

July 16, 2015

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.

July 16, 2015

Barnett International

Negotiation Skills for Clinical Research Professionals

3:00 PM - 4:30 PM Eastern

The ability to negotiate effectively is a core competency for all clinical research professionals. Yet many people find negotiating to be an intimidating experience. Take this interactive web seminar and dramatically improve your ability to negotiate in any situation. With specific examples and real world case studies drawn from clinical research, you will be able to immediately implement the skills you learn with ease. This web seminar will provide a rich learning experience in implementing negotiation best practices.

July 17, 2015

Barnett International

Writing Quality SOPs: Guidelines, Tools, and Templates for Easy SOP Creation

12:00 PM - 2:30 PM Eastern

Standard Operating Procedures (SOPs) are detailed written instructions that allow one to execute a process uniformly. Many SOPs are not well defined or well written, and actually fall short of providing the details needed for one to complete the process. In fact, many who are assigned the task of creating SOPs lack the basic understanding of what constitutes a well written SOP. Often SOPs appear to be no more than a brief Note to File, leaving gaps in the proper execution of the task delegated. Poorly written SOPs also leave organizations vulnerable in the event of an audit. In this web seminar, FDA Warning Letters will be reviewed to demonstrate the consequences of poorly written SOPs. This course offers guidance to those who recognize they need SOPs, or more detailed SOPs, but do not know how or where to start. Participants will be provided with guidelines and templates that ensure that new and updated SOPs are uniform and user-friendly.

July 20, 2015

Barnett International

Monitoring Visit Reports for Medical Device Studies

9:30 AM - 11:00 AM Eastern

In this web seminar, we will discuss how to write effective monitoring visit reports for medical device studies. Participants will learn the purpose for monitoring investigational sites and the importance of documenting the visit. We will examine the requirements for the documentation in the Code of Federal Regulations and International Conference on Harmonization Guidelines, and discuss how the report is used by various stakeholders. Tools will be provided to enable learners to scrutinize various sections of the report to better document what was accomplished on the visit. This documentation supports the adequate monitoring obligation expected by regulatory authorities.

July 20, 2015

Barnett International

Strategies for Managing Difficult Clinical Research Sites

12:00 PM - 2:00 PM 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.

July 20, 2015

Barnett International

Detecting Risk Signals in Protocols, Data, and Monitoring

1:00 PM - 2:30 PM Eastern

In an environment where remote monitoring and management techniques are becoming the daily practice, preventative measures need to be implemented to identify risks. You need to be able to identify protocol data thresholds and parameters for risks to establish management and escalation triggers. As data becomes available in real time, you should not be waiting to intervene until deviations become a “trend” before intervention is implemented; you need to know how to look for outliers and “red flags” on a daily basis. With the increasing use of CROs and vendors, it is essential that best practices are established for identifying risk signals in management and monitoring practices. In this web seminar, we will discuss how to detect risk signals in protocols, data, and monitoring based on risk-based quality management, industry guidances, and practical application.

July 20, 2015

Barnett International

Sponsor Responsibilities for Global Drug Studies

3:00 PM - 4:30 PM Eastern

This web seminar covers the sponsor’s responsibilities for the conduct of a global drug study. Participants will learn the 23 responsibilities assigned to a sponsor for a global clinical study based on the International Conference on Harmonization (ICH) requirements. These essential requirements for compliance to regulations are useful when dealing with the FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), and Health Canada (HC), among other global regulatory authorities. Focusing on the importance of documentation, participants will learn how to put these concepts into practice.

July 21, 2015

Barnett International

Cases in Advanced GCP: A Problem-Solving Practicum

12:00 PM - 3:00 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.

July 22, 2015

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.

July 22, 2015

Barnett International

Warning Letters: Applying Lessons Learned from Misbranding and Adulteration Noncompliance Findings

1:00 PM - 2:30 PM Eastern

In this web seminar, we will focus on common themes such as misbranding and adulteration found in warning letters issued by the FDA to pharmaceutical, medical device, and biotechnology companies. Specifically we will review the concepts of misbranding and adulteration in detail, and provide examples of where compliance issues commonly arise in these areas. We will discuss best practices for responding to warning letters, as well as strategies that can be implemented to help avoid them. Whether you are new to the warning letter experience or you are working on issues in response to one, you will find this web seminar useful.

July 23, 2015

Barnett International

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

8:30 AM - 11:00 AM 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 23, 2015

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.

July 23, 2015

Barnett International

Strategies for Developing Effective Training and Facilitation Skills in Clinical Research

1:00 PM - 2:30 PM 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. If information is not internalized by the learner, then the time spent discussing it is a waste and the consequences may be significant. In this web seminar, training and facilitation methodology, skills, and fundamentals will be discussed. We will focus on the practical application and tools needed to ensure that an audience is able to remember and apply the information shared.

July 24, 2015

Barnett International

Investigational Product Accountability Best Practices

9:30 AM - 11:00 AM Eastern

One of the top regulatory findings both in the U.S. and in global inspections is related to investigational product (IP) accountability. In this web seminar, we will discuss the common sources of error, recommend procedures and training techniques, and evaluate the differences in investigational and non-investigational products. Investigator and sponsor responsibilities will be described, as well as “best practices” for implementation of those responsibilities.

July 28, 2015

Barnett International

Sponsor Management of Investigator Non-Compliance

12:00 PM - 2:00 PM Eastern

Investigator non-compliance to the Statement of Investigator commitments has increased in many areas. One of the identified causes has been monitoring. Investigator compliance issues are great risks to product development success, but an even greater risk to sponsors is the lack of formal systems to manage compliance at research sites. With the promise of more sponsor inspections, the sponsor management of investigator noncompliance is an obligation that requires comprehensive management approaches that lead to control of investigational product, data integrity, and adequate documentation for regulatory inspection of sponsors monitoring programs and/or investigative sites. Seven steps in compliance management of research sites will be presented for the participants to assess their current practices for gaps and risks for preparing for potential regulatory inspection evaluating compliance management of research sites.

July 29 - September 30, 2015

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.

July 30, 2015

Barnett International

The IND in a CTD/eCTD Format

12:00 PM - 1:30 PM Eastern

The Common Technical Document (CTD) format is now the required format for all marketing applications in the U.S., EU, Japan, Canada, and Australia. Clinical Trial Applications (CTAs), the required format of INDs in most countries, are required to be in the CTD format. Currently, the U.S. does not require INDs to be in the CTD format, but rather the traditional format (per regulations in 21 CRF 312.23). However, since all marketing applications are required in the CTD format, it is more efficient to start the IND in the CTD format. If you use the traditional format, the IND and all amendment information must be converted to the CTD format prior to marketing application submission. This conversion time can impact the timeline for marketing application submission, so why not plan ahead for a successful marketing application and start the IND in the CTD format?

July 30, 2015

Barnett International

Medical Writing Fundamentals: How to Write Regulatory Documents

2:30 PM - 4:00 PM Eastern

Medical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve. This web seminar will give learners a broad overview of writing practices, formatting, working with tables and figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. In addition, real-life examples of strategies for generating a great document each time by understanding the what and why of the different documents will be presented.

August

August 3, 2015

Barnett International

FDA Medical Device Approval Process

9:30 AM - 11:00 AM Eastern

This web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH guidance — Investigational Device Exemption (IDE) and abbreviated IDE processes. This is done by reviewing sponsor and investigator obligations, along with the principles of Good Clinical Practice (GCP). Definitions used by sponsors and regulatory authorities for device development will be reviewed. Participants will become familiar with the regulatory decision-making process used by the FDA and learn to navigate the approval pathways to market.

August 3, 2015

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.

August 3, 2015

Barnett International

FDA's Role in Device Safety Inspections

3:00 PM - 4:30 PM Eastern

The primary role of the FDA or other regulatory authority is to protect public health and ensure that devices are safe and effective. This is done by systematically reviewing all data to ensure it is valid and obtained under proper conditions. The FDA has authority to conduct inspections according to the Code of Federal Regulations. This web seminar examines the types of inspections conducted by the FDA and the mechanics of the inspection of a device sponsor as well as an investigational site. Participants will learn the most common audit findings and possible regulatory actions. Several FDA Warning Letters will be reviewed to demonstrate the thoroughness of a regulatory review. Tips will be provided for the management of the inspection activities both during and after the inspection.

August 4, 2015

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 4, 2015

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.

August 5, 2015

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 course will also include handouts and discussion of the TMF Reference Model.

August 10, 2015

Barnett International

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

9:30 AM - 11:00 AM Eastern

Strategies for saving time and money, without compromising oversight and quality, are an ongoing challenge within the industry. In an age where technology is ever present from ordering medications online, consulting with a physician, and having “live” conversations in chat rooms about medical issues, the clinical research industry has been slow to maximize the use of technology. With sponsors/CROs implementing the FDA’s final guidance on a risk-based approach to monitoring, time on site is being reduced to one day visits and/or on-site visits are scheduled few and far between per monitoring plans. Better utilization of remote monitoring is critical to ensure sites are compliant and the data is accurate and consistent. During this web seminar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what “red flags” to look for that may indicate issues on site.

August 10, 2015

Barnett International

Implications of the FDA Guidance for a Risk-Based Approach to Monitoring

12:00 PM - 1:30 PM Eastern

The FDA’s Guidance for the Monitoring of Clinical Investigations (1988-2010) has been removed from the FDA list of guidance documents. Instead, the FDA has released an updated version of the Bioresearch Monitoring (BIMO) Compliance Program Guidance Manual for Sponsor/CRO and Monitoring. In August 2013, the agency issued a final guidance to reflect their expectations and recommendations related to monitoring investigation sites, monitoring systems, and investigative site oversight. In this web seminar, the content and the implications to sponsor monitoring and clinical investigation sites will be discussed.

August 11, 2015

Barnett International

CRO Selection Criteria, Evaluation, and Establishing the Relationship

1:00 PM - 2:30 PM Eastern

Outsourcing to Contract Research Organizations (CROs) to complete studies has become a foundation for pharmaceutical and device companies. With the lengthy drug development and approval process, it is nearly impossible to have complete study teams kept as full-time employees as the workload continually ebbs and flows. One of the challenges of outsourcing is selecting the right partner and then maintaining a team atmosphere where everyone takes ownership of the study. Key considerations when collaborating successfully with a CRO are selecting the right partner by knowing what questions to ask; establishing a foundation for the partnership with clear expectations, goals, and communication; and maintaining a sense of ownership in the work that has been outsourced. This web seminar will address the key criteria in selecting a partner, as well as review the necessary processes to foster positive relationships and allow for high quality performance of the CRO.

August 11, 2015

Barnett International

Essential Documentation in Clinical Trials at Research Sites

1:00 PM - 3:00 PM Eastern

Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance.

August 17, 2015

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 17, 2015

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 17 - September 28, 2015

Barnett International

30-Hour Clinical Project Management Fundamentals Certification Program

1:00 PM - 4:00 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 18, 2015

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.

August 19, 2015

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.

August 20, 2015

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 20 - October 29, 2015

Barnett International

30-Hour Clinical Research Auditing Certification Program

6:00 PM - 9:00 PM 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.