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Webinars

February | March |

March

March 2, 2015

Barnett International

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

9:30 AM - 11:30 AM Eastern

Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This web seminar will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).

March 2, 2015

Barnett International

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

12:30 PM - 2:30 PM Eastern

As the use of electronic source documentation (eSource) increases, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, the FDA issued a draft guidance regarding the use of eSource, providing direction on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. A final guidance was released in September 2013 focusing on identification and specification of authorized source data originators, the creation of data element identifiers to facilitate examination of the data audit trail, capture of source data into the eCRF, and Investigator responsibilities. 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.

March 3, 2015

Barnett International

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

8:30 AM - 11:30 AM 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.

March 3, 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.

March 3, 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.

March 4, 2015

Barnett International

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

1:00 PM - 2:30 PM Eastern

Partnerships with clinical vendors are critical to the success of the trial. Sponsors, as well as vendors who hire other vendors, require both performance and quality oversight. Whether your organization hires different vendors per protocol/program, or you’re in a preferred provider partnership model, you always encounter potential risks. This web seminar will provide a systematic, structured, proactive approach to risk management in outsourced clinical trials. We will discuss the internal and external factors for the organization to identify, assess, manage, and continuously monitor throughout the life of a project and/or partnership (e.g., protocol, investigational plan, regions, sites, vendors, and resources).

March 5, 2015

Barnett International

Introduction to Data Management

9:30 AM - 11:30 AM 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.

March 6, 2015

Barnett International

Investigational Product Accountability Best Practices

1:00 PM - 2:30 PM 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.

March 9, 2015

Barnett International

Data Management in the Electronic Data Capture Arena

1:00 PM - 2:30 PM Eastern

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

March 10, 2015

Barnett International

Quality Risk Management in Clinical Trials and Pharmacovigilance

9:00 AM - 10:30 AM Eastern

The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

March 10, 2015

Barnett International

Current FDA and EMA Inspection Findings: Lessons Learned

9:30 AM - 11:00 AM Eastern

Failure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples from the current top inspection findings, and discuss appropriate corrective and preventative actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future.

March 10, 2015

Barnett International

Ensuring Success Through Smarter Site Selection and Study Feasibility

1:00 PM - 2:30 PM Eastern

Site selection is a complex dance between sponsors and sites. The wrong choice can have serious consequences, impacting quality, time, and finances for both the sponsor and investigator. In this web seminar, the steps for site selection and study feasibility will be discussed. Sponsors will learn the most critical questions to ask an investigator and staff to ensure quality and timely data as well as appropriate enrollment. Sites will learn how they can be proactive in the selection process and how to ensure the study is feasible.

March 11, 2015

Barnett International

Building Relationships with Clinical Research Sites

1:00 PM - 2:30 PM Eastern

Relationships between sites and sponsors are often strained, and poor communication can interfere with having a productive study. Sites are contacted by multiple personnel during the study start-up process, and perhaps even during the study. By focusing on building relationships with the sites, the delays and errors in the startup and ongoing study process can be avoided. It is critical that the individuals working with the sites are in a position through training, knowledge, and support to positively reflect the sponsor and to ensure there is no gap in communication. This web seminar will focus on a variety of techniques for clinical study teams to use in building stronger relationships with the sites. Real-life scenarios and problem solving techniques will be discussed based on what can appear to be unreasonable monitor and sponsor requests to the site research staff.

March 11, 2015

Barnett International

EMA and FDA Inspections: Key Differences and Similarities

1:00 PM - 2:30 PM Eastern

The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) collaborated and performed official joint Good Clinical Practice (GCP) inspections of sponsors, CROs, and investigational sites between 2009 through 2011. Those collaborations have continued into 2014. In this web seminar, we will review the Report on the Pilot EMA-FDA GCP Initiative, and discuss the similarities and differences between EMA and FDA inspectors and inspection processes conducted over the last five years using recent examples of joint inspections. Clarification will also be provided for reporting of Serious Breaches in the UK along with a review of common inspection findings.

March 12, 2015

Barnett International

Data Management: Key Regulations Impacting the Role of the Clinical Data Manager

9:30 AM - 11:00 AM Eastern

In conducting clinical research, there are some specific regulations that directly impact the discipline of Clinical Data Management (CDM). 21 CFR Part 11 includes mandatory regulations that govern clinical trials data. It requires a system in which electronic records and signatures are trustworthy, reliable, and secure; electronic signatures that are equivalent to paper records and handwritten signatures executed on paper; a system that discerns invalid or altered records; and signatures that are linked to an electronic record. The “Guidance for Industry—Computerized Systems Used in Clinical Trials,” builds on the importance of information inclusion when utilizing computerized systems.

March 12, 2015

Barnett International

Leading Teams in a Changing Clinical Research Environment

12:30 PM - 2:30 PM Eastern

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

March 13 - May 29, 2015

Barnett International

10-Week Clinical Research Associate (CRA) On-Boarding Program

12:00 PM - 3:00 PM Eastern

The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA. The course provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biologic, and device trials. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both U.S. and global audiences. Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, and scenario review, as well as application-based homework assignments.

March 13, 2015

Barnett International

Study Initiation Strategies for Sponsors: Study and Site Start-Up

1:00 PM - 2:30 PM Eastern

Study start-up and initiation is one of the busiest times in the research study process. As sponsors and Contract Research Organizations (CROs) are faced with a tight timeline to get all sites up and running — critical elements of the training and communication process are often overlooked. This web seminar will focus on the steps that need to be taken to ensure start-up success at both the sponsor and site level, allow for proactive preparation, reduce the study learning curve, and eliminate study deviations and errors.

March 16, 2015

Barnett International

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

8:30 AM - 10:30 AM 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.

March 16, 2015

Barnett International

Preparing Clinical Research Sites for FDA Inspections

12:00 PM - 2:30 PM Eastern

This web seminar is designed for participants that are sponsors/CROs and research site representatives preparing for a research site FDA inspection. From audit readiness to action item resolution, each site faces its own unique challenges. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection.

March 17, 2015

Barnett International

Using Data to Identify Risk Indicators in Risk-Based Monitoring

9:30 AM - 11:00 AM Eastern

This web seminar will provide centralized monitoring techniques for prioritizing sites and patients in need of on-site monitoring and education. These techniques are useful when using either a risk-based monitoring approach or 100% Source Data Verification, and include both a priori “risk indicators” and dynamic error detection during study execution. Emphasis will be placed on how monitors, data managers, and statisticians can work together to prioritize the data at highest risk of causing problems and prevent errors in the database. Novel techniques for identifying fraudulent data will also be addressed. When monitors, data managers, and statisticians apply these techniques, they will be able to implement a successful risk-based monitoring plan that is practical and cost-effective, while improving the overall quality of the data.

March 17, 2015

Barnett International

Introduction to Clinical Research

1:00 PM - 2:30 PM Eastern

Have you ever wondered what clinical trials are and how they are conducted? This web seminar is designed to answer those basic questions. We will look at how drugs progress from discovery to testing in humans, and learn what it takes to obtain approval to treat a disease or condition. We will discuss the similarities and differences between drug and medical device development. Finally, we will review how Good Clinical Practice (GCP) is designed to protect clinical trial participants and ensure that the information obtained during a clinical trial is accurate and reliable.

March 18, 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.

March 19, 2015

Barnett International

Strategies for Ensuring Good Documentation Practices (GDP)

9:30 AM - 11:00 AM Eastern

Good Documentation Practice (GDP) in clinical research is a baseline expectation; however, there are no set guidelines around what comprises GDP in a Good Clinical Practice (GCP) environment. In this web seminar, we will look closely at the key features of GDP by first examining the question: What is a document? At its core, a document is information (meaningful data) and its supporting medium, which could be in the form of paper, CD, computer files, or microfilm. Documentation is a process which comprises multiple steps: Recording of data, review of documents, approval of documents, issuance and disposal of documents, retrieval of documents, and presentation of documents. In addition, this web seminar will examine the issues identified when documentation has been subject to agency review, and the steps that can be taken to ensure that your approach to clinical trial documentation demonstrates the quality processes that have been applied to your documentation efforts.

March 19, 2015

Barnett International

SDTM and CDASH: What's the Connection?

1:00 PM - 2:30 PM Eastern

Currently, the FDA requires that clinical trial data be electronically submitted in the Clinical Data Interchange Standards Consortium (CDISC) format for consideration for a new drug/biological approval. A significant element in this submission is the Study Data Tabulation Model (SDTM). This web seminar will examine the information defining the concepts of the SDTM as presented in the documentation Version 1.4. The purpose of data standards, benefits of applying these standards, and the relationship between datasets and records will be examined.

March 19, 2015

Barnett International

Protocol Deviations: Documenting, Managing, and Reporting

1:00 PM - 3:00 PM Eastern

According to both U.S. regulations and the ICH Good Clinical Practice: Consolidated Guideline, Clinical Investigators are required to conduct a clinical trial in compliance with the investigational plan/protocol. Protocol deviations should not be implemented without sponsor agreement and the prior approval/favorable opinion from the IRB/IEC, except when necessary to eliminate an immediate safety issue for research subjects. However, unapproved protocol deviations occur in every study and at every site.

March 20, 2015

Barnett International

Introduction to Statistics for Non-Statisticians

8:30 AM - 11:30 AM Eastern

This web seminar is intended for clinical research professionals who have little or no background in statistics. In it, we will cover the basic statistical concepts needed to understand the roles statistics play in health research. The topics addressed include types of variables, levels of measurement, descriptive statistics, precision, confidence intervals, and an introduction to hypothesis testing. This web seminar is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Emphasis will be placed on understanding statistical information and not on calculations or statistical formulae.

March 23, 2015

Barnett International

Key Components of Strategic Clinical Research Operational Planning

9:00 AM - 11:00 AM Eastern

This web seminar will examine the concepts and applied techniques for cost estimation (PERT analysis, bottom-up, top-down, etc.), budget development, risk management, and quality assurance for clinical research projects. Project management principles and methodology are provided with a special focus on planning, controlling, and coordinating individual and group efforts. Key topics include organization strategy and project selection, defining a project, developing a project plan, scheduling resources, risk analysis, work breakdown structures, project networks, process mapping, and building high performance teams. The needs of project managers who aren’t familiar or experienced with specific technical tasks involved in clinical trial management will also be discussed.

March 24, 2015

Barnett International

Quality by Design: A Lean Six Sigma Approach to Risk-Based Monitoring

9:30 AM - 11:00 AM Eastern

Monitoring consumes 30-60% of an operational budget for clinical trials or clinical programs. To sustain growth and reinvest in innovation, sponsors must find viable alternatives to reduce the resource burn, as well as create efficient and effective solutions to increase regulatory compliance, data integrity, and patient safety. By utilizing the combined toolboxes of Lean Six Sigma (LSS) + Quality by Design (QbD), sponsors can continue to invest in innovative products while producing customer-centric/efficient operational processes that are highly adaptable, constantly reproducible, and consume fewer resources. LSS + QbD provides CRAs and other risk-based monitoring staff with an arsenal of analytical tools to conduct fewer on site monitoring visits yet monitor the site more effectively and in real-time.

March 24, 2015

Barnett International

Regulatory Intelligence

12:00 PM - 1:30 PM Eastern

The constantly changing regulatory environment necessitates keeping abreast of current information from a variety of sources. Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc. There is more to RI than keeping up with the latest regulations and guidelines. Regulatory precedence, industry practices, regulatory agency opinions, and competitor information are just a few of the valuable sources of information that can help regulatory affairs professionals to develop successful regulatory strategies.

March 25, 2015

Barnett International

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

1:00 PM - 3:00 PM Eastern

The use of social media in all aspects of the research enterprise has grown exponentially. Researchers from across disciplines and institutional types are finding innovative ways to facilitate research, from online recruitment mechanisms to informed consent portals. Concurrently, researchers and their ethics review boards have been grappling with ethical and regulatory challenges as technologies continue to change rapidly, resulting in a flurry of new questions: Can I use social media to find “lost to follow up” subjects? Can I join a support group to find subjects? What regulations exist around the use of social media? Just what is public information?

March 26, 2015

Barnett International

Auditor Emotional Intelligence

9:00 AM - 11:00 AM Eastern

Audits are often viewed as transactional and factual – and rightly so! They are transactional (a process carried out) and must be factual, devoid of as much personal bias and emotion as possible. However, the power of advanced soft skills in enhancing both the transactional and factual aspects of an audit cannot be underestimated. We have all heard stories of painful audits with auditors who possessed little to no soft skills. The use of appropriate, advanced soft skills serves to reinforce a culture of quality with the auditee. The most important soft skill a quality professional can possess is emotional intelligence.

March 26, 2015

Barnett International

Critical Decision Points in Design and Conduct of Patient Registries

12:00 PM - 1:30 PM Eastern

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.

March 27, 2015

Barnett International

Case Narrative Writing for Reporting Adverse Events

9:30 AM - 11:00 AM Eastern

A narrative is a short document that is required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to briefly describe the events in the life of a patient. These narratives are required when a patient enrolled in a study, after taking the study medication or approved drugs (post-marketing), has discontinued the study because of an adverse event, had one or more serious adverse events, or died. FDA, EMA, and International Conference on Harmonization (ICH) guidance documents call for the submission of a study subject’s experience in narrative form for those who meet these specific criteria. This web seminar will provide a set of guidelines, instructions, and templates for the writing of clinical and post-marketing case narratives for reporting adverse events.

March 30, 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).

March 31, 2015

Barnett International

Good Clinical Practice (GCP) for Medical Devices: ICH GCP and ISO 14155

9:30 AM - 11:00 AM Eastern

Both ICH E6 and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use ICH as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

March 31, 2015

Barnett International

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

12:30 PM - 2:30 PM Eastern

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at 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.