12:00 PM - 2:00 PM Eastern

Regulatory authority inspection trends are identifying a need for truly effective Good Clinical Practice (GCP) training. GCP training should ensure that clinical research stakeholders not only “know GCP” but know how to apply the principles of GCP in their work lives. The decision to develop and implement a GCP Training Program is a time-consuming and expensive project for any clinical research organization. How can you maximize the effectiveness of the training to ensure return on this investment in both financial and compliance terms? By designing GCP training with a focus on engaging adult learners, which is critical to ensuring both acceptance by the learners and the transfer of knowledge into everyday professional practice. This web seminar will identify key elements to consider throughout the phases of program development and design, training deployment, and post-course assessment.

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.

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 Notes to File, the questions to ask to determine if an NTF would be beneficial, and the components of a quality NTF, if being used.

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.

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.

1:00 PM - 3:00 PM Eastern

This web seminar addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between the FDA and sponsors to provide clear direction to support marketing of the medical device.

12:00 PM - 2:30 PM Eastern

Managing compliance in the research industry is vital to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, intervene, and then evaluate the effectiveness of the intervention. Without root cause analysis, interventions cannot be effectively identified and designed. Millions of dollars are wasted yearly on ineffective interventions. This web seminar will present the scientific concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research, the sponsor, CRO, site, and Institutional Review Board (IRB).

1:00 PM - 2:30 PM Eastern

To ensure compliance, regulatory authorities routinely conduct inspections of companies’ drug safety operations. To prepare for an inspection, you must perform a thorough drug safety and pharmacovigilance audit. An internal audit will assess your company’s compliance with applicable worldwide laws, regulations, and guidances. Indeed, regulatory inspectors will look for evidence that such an audit has taken place. This web seminar will provide participants with practical strategies for preparing for a safety inspection at their company via an internal audit.

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 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.

8:30 AM - 11:30 AM Eastern

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

12:00 PM - 2:30 PM Eastern

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

12:00 PM - 3:00 PM Eastern

The roles and responsibilities of the Principal Investigator (PI) are essential for quality data and regulatory compliant clinical trials, but the PI remains an under-trained position in the industry. Because of the critical role the PI plays during a clinical trial, there is debate within the industry of mandatory certification for the PI and/or site accreditation. Documentation of industry training is essential. This course reviews the clinical trial core competencies required for the principal investigator in accordance to the federal regulations, ICH GCP Guidelines, and industry best practices.

1:00 PM - 3:00 PM Eastern

This web seminar will provide attendees with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed.

8:30 AM - 10:30 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.

12:00 PM - 2:00 PM Eastern

Research sites’ performance in conducting clinical trials can be improved through formalized proactive planning and management. Research sponsors commonly develop a monitoring plan for each study protocol to address the unique needs of each project to promote monitoring excellence and flexibility for protocol changes. Research sites can develop a similar plan to support departmental policies and practices to meet the demands and differences between sponsor/CRO projects. This web seminar will present components of a Proactive Compliance Plan (PCP) for research sites use in promoting high performance management of multiple research studies to meet sponsor and regulatory requirements.

12:30 PM - 3:30 PM Eastern

This web seminar provides an excellent introduction to clinical research data management, focusing on processes and their rationale, making it ideal for the new data manager and other individuals who wish to learn basic clinical data management functions.

12:00 PM - 2:00 PM Eastern

Proper completion of the Statement of Investigator has been greatly debated. Many stakeholders differ in opinions on what is accurate and adequate in completing this form. For example, who should be listed as subinvestigators, do we need to complete a 1572 for certain projects, and so forth. This web seminar will review the 2010 FDA information sheet and answer many of the questions about how to properly complete the form. The course will also discuss what is still not clear even after the guidance and how to get the answers.

12:30 PM - 3:30 PM Eastern

Fueled by the encouragement from regulatory agencies in the U.S. and Europe, the art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last few years. Due to recent governmental initiatives such as the Pediatric Research Equity Act (PREA) in the U.S. and Pediatric Investigation Plans (PIPs) in Europe, pharmaceutical companies have been given clear pathways and incentives to develop drug indications and products for this important group of patients. This web seminar will examine these regulatory initiatives and discuss practical and effective development approaches and study designs.

8:30 AM - 11:00 AM Eastern

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.

12:00 PM - 2:30 PM Eastern

Monitoring a clinical trial is a required activity completed by sponsors of FDA regulated research that significantly affects the outcomes of product development and approval. Effective management of CRAs’ performance by sponsors is essential. Promoting improvement in overall and individual monitoring is also important. Performance Management and Improvement is a science involving logical processes and applications. This web seminar will present the concepts of the Human Performance Improvement (HPI) Model and apply it directly to the management of the CRA to promote improvements. The HPI CRA Management Model will be presented and applied via case scenarios for better understanding.

9:00 AM - 10:30 AM Eastern

The FDA requires investigators to complete and maintain adequate and accurate case histories for every research subject, including all pertinent information that will aid in reconstructing and evaluating the trial source data. In this web seminar, we will define what pertinent data is and what the requirements are for the maintenance of the case histories. We will also review the importance of understanding and implementing the ALCOA standard, which ensures that records are attributable, legible, contemporaneous, original, and accurate, whether they are paper or electronic.

1:00 PM - 3:00 PM Eastern

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.

9:00 AM - 11:00 AM Eastern

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.

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?

Currently, there is no guidance document to facilitate the transfer or mapping of information from the IND requirements contained in 21 CFR 312.23 to the CTD format. There is often a difference of opinion on where information should be stored. This web seminar will give an overview of the IND requirements and where they can most effectively "fit" into the CTD requirements for a streamlined FDA review and building of the IND into a marketing application.

2:30 PM - 4:00 PM Eastern

An integral part of any successful regulatory strategy is meeting with a regulatory agency, early and often, to reach concurrence on development plans. To ensure that your strategy is well communicated and that a successful meeting occurs, the process must be seamless. You need to know all the components of the FDA’s meeting requirements as well as the elements that are not requirements but make the process smoother. While some of the concepts are the same, the regulations and meeting content are different. What a company needs to discuss with the agency during a Pre-IND meeting is quite different than an End of Phase 1 or 2 meeting, and the needs for the Pre-NDA meeting are vastly different from the earlier meetings. All Phase 1-3 meeting types will be discussed and specific requirements will be reviewed.

12:00 PM - 2:00 PM Eastern

During monitoring visits one of the most important and impacting activities that a CRA performs is the source document verification of Adverse Events (AEs). The CRA is the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety regulatory and ICH definitions will be reviewed and applied to the monitoring process. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

12:00 PM - 2:00 PM Eastern

This web seminar presents an overview of the patient recruitment arena, and focuses on strategies for successful clinical trials including systematic protocol feasibility, pre-screening approaches, and insourcing and outsourcing options. Included in the program are discussions for handling tough populations and the ethics of participant recruitment in clinical trials.

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.

12:30 PM - 2:00 PM Eastern

Widely reported industry statistics suggest that some 86% of trials fail to meet their enrollment goals. Inevitably, one intervention that is often considered is whether or not to hold a study rejuvenation meeting or site engagement meeting as a means for re-motivating investigators to accelerate enrollment. This web seminar is designed to help clarify what is an effective rejuvenation meeting, what goes into the planning, how it should be structured, and what the expected outcome looks like. At the heart of the matter is diagnosing and troubleshooting the enrollment or site engagement issues, and applying some specific parameters around the decision-making to determine whether the time and resource investment to hold a rejuvenation meeting (or series of meetings) is warranted for the potential return on investment.

12:00 PM - 3:00 PM Eastern

During the course of clinical research, the Investigator’s Brochure (IB) is the data repository for an investigational product; effectively this is the product’s “label” during the investigational stage. The IB is a dynamic document which changes as the information changes. It is critical in clinical research as physicians and Institutional Review Boards (IRBs) refer to the IB on an ongoing basis to answer questions about Serious Adverse Events, Adverse Events, dosing, manufacturing, and clinical and nonclinical study results.

To facilitate the transfer of information, the IB must be concise, well-written, and provide a summary for a physician to quickly reference. While ICH E6 provides an outline of the requirements, how companies address these requirements and the degree of information provided differs. The required contents will be reviewed in this web seminar. Tips and techniques for effective writing, including pulling together the needed information, working with a team, and writing a summary will also be discussed.

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.