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Webinars

April | May |

April

April 1, 2015

Barnett International

Establishing a Vendor Management Program

1:00 PM - 2:30 PM Eastern

As vendor/contractor/subcontractor/supplier relationships and usage increase in use and complexity, vendor management is receiving more attention as a way for organizations to achieve a competitive advantage and make their outsourcing relationships part of their long-term success plan. However, while the benefits of vendor management programs have been widely reported, many organizations still lack the guidelines and tools to successfully implement such a program. This web seminar is designed to present techniques and best practices to establishing and monitoring a vendor management program. During the course, we will discuss the various roles and responsibilities, strategies to categorize and monitor vendors, and the benefits of a vendor management program.

April 1 - June 3, 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.

April 3, 2015

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.

April 6, 2015

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.

April 7, 2015

Barnett International

Monitoring Plan Development

8:30 AM - 10:30 AM 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.

April 7 - May 7, 2015

Barnett International

30-Hour Clinical Project Management Fundamentals Certificate Program

9:00 AM - 12:00 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.

April 7, 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.

April 7, 2015

Barnett International

Risk-Based Monitoring: The Data Management Connection

12:30 PM - 2:30 PM Eastern

The final guidance, “Guidance for Industry: Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring” was released in August 2013. To quote from the new guidance, “… monitoring refers to the methods used by sponsors of investigational studies, or CROs delegated responsibilities for the conduct of IND studies, to oversee the conduct of and reporting of data from clinical investigations, including appropriate Clinical Investigator supervision of study site staff and third party contractors.”

April 9, 2015

Barnett International

Writing and Maintaining the EU CTA (Clinical Trial Authorization)

12:00 PM - 3:00 PM Eastern

The Regulatory Affairs department must prepare documents that inform European Regulatory Agencies about the proposed development plan; submit a Clinical Trial Authorization (CTA) to initiate human clinical trials; answer questions about on-going investigations; and construct and submit any updates to the CTA in a concise and informative manner. Regulatory submissions are more than just writing – they encompass strategy, research, writing, organizing and leading a team, compiling, editing, publishing, and tracking of the information. When initiating a global clinical trial program, many moving parts need to be brought into harmony to ensure compliance and that timelines are met. Web seminar attendees will walk away with tools to help plan, write, and manage multiple CTAs with all their differing requirements.

April 9 - June 11, 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.

April 10, 2015

Barnett International

Phase I Study Management

12:00 PM - 1:30 PM Eastern

Because the early life of a compound is dependent on the data and analysis derived from Phase I Studies, it is imperative that these trials are managed and conducted with the highest quality and care. Therefore, well-honed project management skills that can address the unique issues associated with Phase I Studies are needed. This web seminar will examine the importance of Phase I Studies in drug development, the issues commonly associated with conducting a Phase I Study from a sponsor perspective and provide project management best practices specific to overseeing a Phase I Study.

April 13, 2015

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

8:30 AM - 11:30 AM 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.

April 13, 2015

Barnett International

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies

12:00 PM - 1:30 PM Eastern

Non-compliance at research sites requires corrective action planning to address the deficiencies. The corrective action plan should include more than just the identification of the deficiency and intervention chosen to address the issue. Effective corrective action planning includes other important components that lead to promoting improved performance for future activities: Ultimately improved human subject protections and data integrity. Lack of these components can lead to repeated non-compliance and in some cases to rejection of corrective action plans by regulatory authorities.

April 14, 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.

April 14, 2015

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.

April 15, 2015

Barnett International

Writing Clinical Study Reports for Diagnostic Studies

12:00 PM - 1:30 PM Eastern

Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate Clinical Study Reports (CSRs) for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these CSRs, the guidances to follow for reference, basic skills for understanding the data (i.e., false positives, false negatives, and percent agreement), and other diagnostics output and results, as well as coordination with the 510(k) submission.

April 15, 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.

April 15, 2015

Barnett International

Writing Protocols for Diagnostic Studies

2:30 PM - 4:00 PM Eastern

Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate protocols for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these protocols, how they differ from the standard pharma protocols, the guidances to follow for reference, and the regulatory environment surrounding sample collection and informed consents for de-linked samples.

April 16, 2015

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. 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.

April 16, 2015

Barnett International

Medical Writing Fundamentals: How to Write Regulatory Documents

9:30 AM - 11:00 AM 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.

April 16, 2015

Barnett International

Updates in Informed Consent Guidance

12:00 PM - 1:30 PM Eastern

Conducting the informed consent process is one of the most critical tasks to be completed by a research site. It is essential that a subject clearly understand the language in the consent form and that their rights, safety and welfare are not jeopardized in any way. In this web seminar, we will look at the essential language in the informed consent document through review of the FDA regulations and guidance documents, including the “Guidance on Exculpatory Language in Informed Consent” and additional regulatory updates and considerations.

April 16, 2015

Barnett International

The IND in a CTD/eCTD Format

2:30 PM - 4:00 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?

April 17, 2015

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.

April 21, 2015

Barnett International

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

9:30 AM - 11:00 AM 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.

April 21, 2015

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.

April 22, 2015

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.

April 23, 2015

Barnett International

Managing Observational Studies

12:00 PM - 1:30 PM Eastern

Observational studies in the biopharmaceutical and medical device industries encompass various designs and purposes, including post-approval safety studies, product or disease registries, pregnancy registries, medical chart reviews, and cohort studies. This web seminar offers practical approaches to the management of observational studies, focusing on issues and aspects that occur commonly, differ from clinical trial management, and are key to program success. Topics to be addressed include project oversight, ethics/Institutional Review Board (IRB) approvals, data quality management, site and subject recruitment and retention, and protocol adherence.

April 23, 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.

April 27, 2015

Barnett International

How to Write Effective Monitoring Reports and Communications Workshop

9:00 AM - 4:00 PM Eastern

Clinical Monitors (CRAs) must document many details of the happenings at investigational sites, including Confirmation Letters to sites, Monitoring Visit Reports, Follow-Up Letters to sites, Telephone Contact Reports, Email/Faxes to sites, and Queries and Notes to File (NTF). All of these become essential documents as they demonstrate the compliance of the monitor and, thus, the sponsor in the conduct of the clinical trial. These are all eligible for inspection by the regulatory authorities at any time both during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics, and devices. Effective writing skills are, therefore, extremely important so that we show the diligence and detail involved in effective monitoring.

April 27, 2015

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.

April 28, 2015

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.

April 28, 2015

Barnett International

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual

12:30 PM - 2:30 PM Eastern

As scrutiny of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research intensifies, companies are using their quality assurance resources to review internal (and vendor) systems to ensure compliance within a changing regulatory environment. A systematic application of the Compliance Program Guidance Manual (CPGM) permits identification of regulatory risks during qualification and in-process audits. This web seminar will review the FDA’s current guideline for conducting inspections and how to apply them to assess Quality Systems. Assessment of the SOPs that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will also be discussed.

April 29, 2015

Barnett International

Negotiation Skills for Clinical Research Professionals

12:00 PM - 1:30 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.

April 29, 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.

April 30, 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.

May

May 4, 2015

Barnett International

Informed Consent: Execution, Documentation, and Monitoring the Dynamic Process

12:00 PM - 2:30 PM Eastern

This web seminar presents the elements of the informed consent document and the components of the process. Industry specific scenarios are presented to reinforce important concepts, for example: Evaluating and documenting capacity to consent, voluntariness, when a HIPAA authorization is required, withdrawal of consent, and more. Discussions also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research.

May 5, 2015

Barnett International

Improving Readability of SOPs and Other Procedural Documents

12:15 PM - 2:15 PM Eastern

No one really likes reading SOPs. Whether this is a true “necessary evil” or not, this, in itself, makes it important that the associated pain is minimized. More often than not, the contents of the SOPs are simply “tossed” into a document with little ado. Such an approach perpetuates a vicious circle: First, the user, not being able to fully comprehend what they are reading, simply stops reading; then, authors, knowing the document won’t be read, don’t put effort into writing it. The by-product of these events is that compliance suffers.

May 6, 2015

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

12:00 PM - 2:00 PM Eastern

Investigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance.

May 6, 2015

Barnett International

Study Feasibility: Eliminating Low and Late Enrollment

12:30 PM - 2:30 PM Eastern

This web seminar is designed for sponsor/CRO personnel responsible for protocol design and development, country allocation, site selection, and study feasibility assessments. The current study feasibility assessment process is inefficient and is incapable of identifying the best investigative sites to conduct a clinical trial. Feasibility questionnaires and the current process are often not effective in predicting site success in implementing a given clinical trial. This session will explore novel approaches and technologies that can be used to significantly improve the feasibility assessment process at the protocol, country, and site level.

May 7, 2015

Barnett International

State Laws Governing Clinical Trial Regulatory Compliance

1:00 PM - 2:30 PM 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. In this web seminar, we will review many of these key areas, and discuss specific differences. Learners will be provided with examples from more than a dozen practical areas, including age of consent, capacity to consent, IRB and clinical protocol requirements, notification of state agencies, experimental drug dispensing requirements, HIV testing rules, genetic testing, and legal representatives.

May 11, 2015

Barnett International

SOP Writing: How to Create, Implement, and Maintain User-Friendly SOPs Workshop

9:00 AM - 4:00 PM Eastern

In the world of clinical research, it would be difficult to find someone who hasn’t heard of Standard Operating Procedures (SOPs). Yet there remains great mystery in how to create an SOP.

May 11, 2015

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.

May 12, 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.

May 13, 2015

Barnett International

Establishing a Risk Management Framework for Clinical Trial Conduct and Oversight

1:00 PM - 2:30 PM Eastern

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

May 13, 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.