The FDA recently released its much-anticipated Compliance Program Guidance Manual on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. This web seminar will review 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.

The 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.

As the number of clinical research trials conducted outside of the United States increases, the FDA has come under new scrutiny for its ability to monitor and inspect foreign clinical trials. This course will examine the changing landscape of clinical research and how the FDA is adapting its processes to address these challenges. This course will also provide models for site selection, site oversight, and preparing foreign clinical research sites for regulatory inspections. Participants will gain a greater understanding of current FDA inspection trends of foreign clinical research sites.

As the use of electronic source documentation (eSource) increases in clinical research, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, new draft guidance was released regarding the use of electronic source documentation, providing direction to sponsors, Contract Research Organizations (CROs), data management centers, and Clinical Investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. The new draft guidance focuses on the flow of data through those systems from input to analysis and “is intended to promote the capture of source data in electronic form.” This web seminar will review how the requirements for paper source documentation translate to the electronic source document as well as examine real-world examples of the FDA’s review of eSource.

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 recommendationsinto current practices and specific projects are also covered.

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.

After scrutiny from the Office of Inspector General and Congressional reports, the FDA has reexamined its procedures for disqualification of Clinical Investigators and dissemination of information surrounding its processes and determinations. As a result, the FDA has issued a proposed rule that would amend the federal regulations to expand the scope of disqualifications and make information on compliance and enforcement activities more accessible. This web seminar will review the recent changes, the reasons behind them, and what they mean for Clinical Investigators, sponsors, and IRBs.

The DHHS, the United States’ agency that houses both OHRP and the FDA, recently released its announcement for proposed rule changes to the regulations that govern the conduct of human subject research in an effort to streamline, modernize, and increase their effectiveness. Human subject protection regulations have not always kept pace with the evolution of clinical research. As a result, the regulatory requirements to which those involved in clinical research are held accountable are unclear, inconsistent, and outdated. This web seminar will review DHHS’ proposed changes to 45 CFR 46 and 21 CFR 50 and 56 and the factors driving the transformation. Specifically, recent guidance documents and legislation will be linked to better understand how the conduct of clinical research can be utilized to enhance compliance.

The requirements outlined in the federal regulations governing the disclosure of financial interests by Clinical Investigators permit sponsors and the FDA to assess the potential for bias in research by review of specific information. The integrity of data obtained from clinical research studies depends in large part on the ability to ensure that the data is free from bias or conflict of interest. Federal regulations require not only disclosure of this information, but development and implementation of plans to mitigate and manage any perceived or real conflict. This web seminar will focus on clinical research professionals’ responsibilities for disclosing, reporting, and managing potential conflicts that may impact the outcome of the study and the FDA’s review. Discussion will include review of sponsors’ due diligence requirements, regulatory authorities’ refined focus on financial information in clinical research, and the FDA’s actions and recommendations for ensuring requirements are met.

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.

Phase I trials require an additional monitoring skill set. The 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.

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.

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.

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.

The FDA’s Guideline 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, and most recently the agency released a draft 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.

This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.

The online 10-Week Clinical Research Associate (CRA) “on-boarding” training course is appropriate for individuals who have less than two years experience as a Clinical Research Associate. 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. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both US and global audiences. Core 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.

This course is built on Barnett’s deep in-person CRA training experience and is designed for “on-boarding” of individual new hires or entire teams. If you are a CRA manager or human resources professional responsible for the orientation and training of one new CRA or 100, this course provides a convenient, cost-effective, comprehensive, and interactive training method. You’ll have the peace of mind knowing that you are training your new hires to the highest industry standards.

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.

This course provides newcomers a detailed and thorough introduction of FDA regulations in the field of medical device safety. The course includes a comprehensive review of the requirements, current compliance approaches for professionals in the research and post-marketing areas, and opportunities to discuss the challenges facing those reporting and managing Adverse Events in the medical device industry.

Protection of human research subjects and data integrity are the two central tenets of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) worldwide. In this interactive web seminar you will learn how the U.S. Food and Drug Administration (FDA) and Health Canada have interpreted ICH GCP guidance. Case studies and other interactive techniques will be used to provide participants with a deeper understanding of clinical research requirements and best practices according to the FDA and Health Canada drug regulations. This web seminar will provide an in-depth focus on drug regulations.

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.

Although registries share some features with clinical development trials, they diverge in many important respects. Clinical, risk management, and product marketing teams can collaborate successfully to develop and implement patient registry programs. All team members should have a clear understanding of the design elements, the operational issues, and the strengths and limitations of registries.

This web seminar will focus on the most critical issues in the design and conduct of patient registries for biopharmaceutical and medical device applications. It will also cover the questions most frequently raised by clinical, risk management, and product marketing teams engaged in the development and implementation of registries.

The FDA released a significant update to the Compliance Program Guidance Manual (CPGM) chapter on Inspection of Sponsors, Contract Research Organizations (CROs), and Monitors (7348.810) in March 2011. This chapter is being revised to incorporate recommendations for improving communications among FDA staff before, during, and after an inspection, and to more clearly define the thresholds for initiating regulatory actions against non-compliant sponsors or CROs. In this web seminar, we will review the changes within the manual, and identify key areas of sponsor activities for audit readiness.

RECIST stands for Response Evaluation Criteria in Solid Tumors. The National Cancer Institute is the best resource for information, and defines RECIST criteria as “a voluntary, international standard, and not an NCI standard. They are based on a simplification of former methods (WHO, ECOG) and based on measurable disease, i.e., the presence of at least one measurable lesion.” RECIST criteria provide a way to standardize measurement of solid tumors worldwide for any clinical trials that include this data to define study endpoints.

RECIST defines and standardizes how and when subjects are seen to progress, respond or remain stable in terms of their metastatic disease burden during a course of therapy. When these criteria are not well understood at the site level or consistently followed during a trial, it can put the study endpoint data in jeopardy.

Web-based is a growing training approach in most industries, and the benefits of training a large group of people with minimum to no travel expenses has contributed to its growth. There are different definitions and approaches to web-based training, such as hosted and non-hosted events that are discussed during this web seminar. Web-based training requires an understanding of various educational and technical concepts and how to apply them for the best outcome. By attending this session, participants will walk away with ideas from educational and technical experts in the field on how to best use this platform of learning.

Investigator selection is one of the most critical tasks facing clinical research professionals in today’s compliance-driven environment. Yet the task is often performed with inadequate time and resources by individuals who are facing multiple competing projects and timelines. How can you better ensure the identification of the best qualified investigator candidates to ensure overall study success? This web seminar will assist participants in developing a strategy for an investigator selection process which includes the following: A detailed and study-specific investigator profile, a truly effective site feasibility questionnaire, leveraging existing staff members’ unique skill sets, and strategies for maximizing the value of site evaluation/selection visits.

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 both drug/biologic and device trials. This program is geared toward individuals seeking a new career or career change into clinical research, but who don’t know which job track to pursue. Case studies and industry best practices are presented to underscore 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.

Before the class starts, you will receive your class books and reference guides. During the live Interactive Web Seminar, you will be able to ask questions and provide feedback. You will be required to pass both a mid-term and a final in order to receive accreditation CEUs. Upon completion, training certificates will be provided to all participants and accreditation CEUs will be requested.