Webinar Replay: We are going to run an Investigator-Initiated Trial!?!? What do we do?

This session will communicate effective, simple checklists and best practices for study start up, patient recruitment, tracking of study progress, training and technology resources, and study close out and reconciliation. Webinar Replay expires on June 26, 2020.

Webinar Replay: Designing, Operationalizing and Maintaining a Comprehensive Assessment Driven Clinical Research Orientation

This session will provide tools and define efforts to create and operationalize a comprehensive, competency based, systematic Clinical Research Workforce Development program. Webinar Replay expires on June 12, 2020.

• Basic, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, , Trainer

Ethics and Human Subject Protection: A Refresher Course

When in need of a comprehensive refresher, this on-demand eLearning course provides a consolidated overview on the history and importance of ethical conduct in clinical trials involving human subjects.

Webinar Replay: ResearchMatch.org: Empowering the Researcher/Serving the Participant

Join us to learn about ResearchMatch, the national recruitment platform that brings together people who are interested in research, with the research community. Webinar Replay expires May 22, 2020.

Webinar Replay: Single IRB: Getting Ahead of the Curve at a Non-Traditional Academic Medical Institution

In early 2018, Ochsner Health System’s HRPP and the Ochsner Cancer Institute embarked on a journey to discover the best way to use a preferred external IRB. This webinar will discuss their experience. Webinar replay expires May 8, 2020.

Webinar Replay: Who Is the Clinical Scientist and What Do They Do?

Explore the scope of the clinical scientist role, how it differs from traditional study or data management roles, and what skills or experience may be relevant. Webinar Replay expires April 24, 2020.

Webinar Replay: What You Need to Know from the 2018 FDA Imaging Guidance

This course will focus on the FDA Guidance released in April 2018. The course will review the sections of the guidance document and provide you with an overall take home awareness of the current FDA feeling on using imaging in clinical trials. Webinar Replay expires March 27, 2020.

• Basic
• Investigator,

Investigator Responsibilities

Learn the various responsibilities of clinical investigators based on FDA Regulations, ICH Guidance Documents, and international standards.

Webinar Replay: Investigator Oversight and Engagement: Creating a Culture of Oversight

Based on the FDA Guidance for Industry: Investigator Responsibilities- Protecting the Rights, Safety, and Welfare of Study Subjects, the presenter will review the guidance document and discuss ideas of creating a culture of awareness in promoting Investigator oversight and engagement at the clinical research site. Webinar Replay expires February 27, 2020.

Webinar Replay: Clinical Trial Billing Basics

This session will explore the basics of billing compliance for clinical trials. Webinar Replay expires February 13, 2020.

Webinar Replay: Tech-Enabled Trials: An Overview of How Technology is Transforming Clinical Trial Operations

In this educational webinar, we will be discussing where the industry stands on the technology adoption curve, industry drivers for the adoption of technology, designing a crawl>walk>run methodology when introducing technology, and a case study of “before and after” at a site. Webinar Replay expires January 23, 2020.

Webinar Replay: GDPR Implementation in Clinical Trials

This 60-minutes session is aimed at providing an overview of the General Data Protection Regulation (GDPR) and translating its specific requirements into a clinical trial environment. Webinar Replay expires January 16, 2020

Webinar Replay: Best of ACRP 2018: Key Privacy and Security Considerations Before, During and After a Study

The session will discuss the privacy and information security concerns that can occur from the time a protocol is drafted through the completion of the study. Webinar Replay expires November 8, 2019.

Webinar Replay: Best of ACRP 2018: Writing, Monitoring and Documenting Protocol Deviations: Practical Tips

Master your understanding of protocol deviations, one of the most common problems identified in FDA inspections and the main reason for the rejection of data from a site or study. Webinar Replay expires November 6, 2019.

Webinar Replay: Best of ACRP 2018: The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance

This session takes a practical approach to risk-based monitoring. Clinical monitors, project managers, and risk managers learn how to maximize their monitoring resources to have the greatest impact on quality and compliance. This Webinar Replay expires November 1, 2019.

Webinar: Steps to Overcome Information Overload in Clinical Research

July 16, 2019, 12:00-1:00 pm – Veeva Systems will discuss the industry perspective on data sharing and collaboration in clinical research, the use of metrics to optimize performance, and strategies that reduce information overload and simplify how sites, sponsors, and CROs work together throughout the clinical trial process.

Webinar: Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance

July 31, 2019, 12:00-1:00 pm – This session will cover identifying, assessing, and reporting adverse events (AEs) for medical device studies at the site level.

Webinar: Multi-Center Investigator-Initiated Trial Guidance: The Best Practices of an Actual Multi-Center IIT

August 14, 2019, 12:00-1:00 pm – This presentation will focus on lessons learned from a recent observational study of 6 clinical research sites over the course of three years.

Webinar Replay: Attaining the Perfect Balance: Objective Protocol Feasibility Scoring

Increasing clinical trial complexity with leaner budgets demand the clinical trial site be more agile than ever. Sites must balance needs to effectively staff trials and distribute workload between team members or justify increasing staff to support growing demands. Webinar replay expires on October 24, 2019.

Webinar Replay: How Can Real World Data Improve the Early Clinical Development Process?

We will review in detail the types of Real World Data (RWD) sources available in the US, Europe and Asia, both proprietary and government-sourced, that can be leveraged to inform trial design and execution. Webinar replay expires on October 3, 2019.

Webinar Replay: Is Your Website Making or Breaking Your Business? How to Improve Your Research Site’s Website and Online Presence

A research site’s website is key to establishing a positive first impression on both patients and sponsors. A website presents an opportunity to convey experience and set a reputable and professional tone. Webinar Replay expires September 19, 2019.

Webinar Replay: INDs and the eCTD Submission Mandate

This program will introduce attendees to the FDA mandate for all submissions (including commercial INDs) to be provided in the eCTD (electronic Common Technical Document) format. This webinar replay expires September 12, 2019.

• Advanced

Improving Recruitment, Accrual, and Retention in Clinical Trials

Explore best practices to improve recruitment and retention with a focus on operational efficiency, cultural competency, and patient centricity. Included tools will help you assess how to better communicate with potential participants and begin a critical reflection of your own skills and organizational practices.

• Advanced

Trial Feasibility and Selection: Their Impact on Accrual

Selecting the right trial for your clinical research site is key to the success of your accrual for the trial. This eLearning course will discuss how the menu or portfolio of studies offered at a site has an important impact on accrual and how research professionals can become part of the process.

Webinar Replay: Simplified and Harmonized Studies in the EU

Explore the requirements and best practices for conducting clinical trials in the EU. This webinar replay expires August 22, 2019.

Webinar Replay: Consorting with Consortiums: Multi-Centered Trial Management

Research Consortiums provide opportunities for investigator initiated multi-centered clinical trials. This webinar will consist of a panel of experts providing best practices and the pitfalls of these types of trials from both the lead site and site coordinator perspective. This webinar replay expires August 15, 2019.

Webinar Replay: Therapeutic Frontiers of Clinical Research

There are many reasons for the design and conduction of clinical trials. The most recognizable objective of clinical trials is to collect and analyze data to demonstrate safety and efficacy to either gain or maintain regulatory approval for use. Webinar Replay expires July 25, 2019.

Webinar Replay: Waiving or Altering Consent for Minimal Risk Trials

FDA regulations and the Common Rule share the same definition for “minimal risk,” but while the Common Rule allows a waiver of informed consent for minimal risk research if specific criteria are met current FDA regulations do not. Webinar Replay expires July 11, 2019.

• Basic

Webinar Replay: How to Enter the Clinical Research Field

There are many paths for entering and navigating clinical research careers. This webinar provides guidance that can help jump start your efforts to become a professional in the field.

• Basic
• CRC, CRN, Investigator, PR, RM

Implementing a Patient-Centered Informed Consent Process

Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language. This eLearning course will provide essential tools for those directly involved in informed consent discussions.

• Intermediate
• CRC, CRN, Investigator, PR, RM

Using Metrics to Improve Subject Recruitment and Retention

Overcome challenges in subject recruitment and retention by learning how to leverage the metrics critical to success. This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring.

• Basic
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Introduction to Good Clinical Practice

Learn the globally recognized standard for conducting ethical and scientifically sound research and to “speak” the universal language of clinical research. This eLearning course is an excellent starting point for anyone wanting to begin work in clinical research and a great refresher for those who have been in the role for some time.

• Basic
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Introduction to Clinical Trials

Fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals. This free eLearning course details how medical products are developed, how volunteer patients are protected, and key roles in the development, research, review, and approval of medical products.

• Advanced, Intermediate

Site Quality Management Tools: SOPs, Metrics and Training

Master quality-related processes and procedures required to ensure trial compliance. This eLearning course is a comprehensive training program that prepares you for the next step of setting up a quality management system– essential information for site personnel involved in quality management and improvement.

• Advanced, Basic, Intermediate
• BCO, CDC, CRC, CRN, CRS, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

Reduce your anxiety by being prepared for clinical trial inspections. This eLearning course takes you through the full cycle of a regulatory authority GCP inspection and answers key questions including: Why, when and where are regulatory inspections performed? Who can be inspected? And more.

• Advanced, Basic, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety

Efficiently identify and report safety events in your clinical trials. This eLearning course, appropriate for all clinical research professionals, guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.

• Advanced, Basic, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Webinar Replay: ICH GCP E6 (R2) – An Overview

This free recorded webinar reviews recent changes to Good Clinical Practice guidelines, including those affecting investigator responsibilities, sponsor responsibilities, essential documents, and more.

• Basic

ACRP Certification Exam Preparation eLearning Course

Prepare for an ACRP Certification with this comprehensive guide. This eLearning course will help you become familiar with the exam format, tackle example questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP Certification.

• Basic, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, DM, Investigator, MA, MD, MRS, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review

Expand your knowledge and skills in study protocol design and review. This e-Learning course covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments.

• Advanced, Basic, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Theory to Practice: Operationalize Your Clinical Study Protocol

Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials.

• Advanced, Basic, Intermediate
• Investigator

Risk-Based Monitoring: The Essentials for Investigators

As an investigator, do you know what risk-based monitoring (RBM) means to you and your trial staff? This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach? It also examines the impact on investigators specifically, including new approaches to data management, study budget and contract considerations.

• Advanced, Basic, Intermediate
• CRC, DM, PR, QCS, RM, RTA, Trainer

Risk-Based Monitoring: The Essentials for CRCs

Become an expert on quality and risk-management strategies and procedures. This eLearning course answers the fundamental questions: What is risk-based monitoring (RBM) and how is it different from the standard monitoring approach? It then examines the impact on CRCs specifically, including new approaches to data management, study budget and contract considerations.

• Advanced, Basic, Intermediate
• DM, MCRA

Risk-Based Monitoring: The Essentials for CRAs

Examine risk-based monitoring’s (RBM) impact on CRAs and the risk management considerations required to implement an effective risk-based monitoring program. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?

• Basic
• BCO, CRC, CRN, DMCTO, Executive, FA, Investigator, MCRA, PMs, RM, RTA, SSSU, Trainer

Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense

Learn the key phases of the budget process and critical components required for consideration, including preparation and study protocol review, study start-up Costs and more. This eLearning course is ideal for both site and sponsor personnel who are tasked with building site budgets and reaching agreeable terms.

• Advanced, Basic, Intermediate
• BCO, CRC, CRN, CRS, DMCTO, Executive, FA, Investigator, MCRA, PMs, RM, SSSU, Trainer

Managing Billing Compliance Risks: Navigating Medicare in Clinical Trials

Keep your trials in compliance by effectively managing Medicare billing compliance risks. This eLearning course will teach you to assess, prevent and address noncompliance risks to ensure compliance with Medicare rules for coverage of clinical trial-related costs in the U.S.

• Advanced, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Key Skills for Ensuring Quality Control through Risk-Based Decision Making

Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives. This eLearning course covers key aspects related to risks in clinical trials, including: identification, analysis, planning, communication, change management and much more.

• Advanced, Intermediate
• CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

ICH Gap Analysis

Assess your and your team’s training needs quickly by conducting an ICH gap analysis. This eLearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines.

• Advanced, Intermediate
• CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

GCP Test-Out Challenge: Demonstrate Your Mastery of GCP

A new take on GCP training! This eLearning course, presented in a game format, assesses your GCP knowledge and ability to analyze and apply GCP principles. This course is recommended for individuals with prior training and experience with ICH GCP.

• Advanced, Intermediate
• Investigator

GCP for the Experienced Investigator: Reducing Risks and Avoiding Common Inspection Findings

Improve study coordination, reduce risk of inspection findings, attract more clinical trials to your site and increase your value as a staff member with this advanced GCP knowledge. This eLearning course examines common inspection findings and proven strategies to avoid them through correct application of the GCP guidelines.

• Advanced, Intermediate
• CDC, DM, Pharmacist, QCS, RM, RTA, Trainer

GCP for the Experienced CRC: Partnering with Your Investigator to Reduce Risk and Avoid Common Inspection Findings

Improve study coordination, reduce risk of inspection findings, attract more clinical trials to your Investigator’s research site and increase your value as a site staff member with this advanced GCP eLearning course.

• Advanced, Intermediate
• DMCTO, Executive, MCRA, PMs, Trainer

GCP for the Experienced CRA: Improving Monitoring Efficiency and Effectiveness

Increase your value as a monitor and take your knowledge and application of ICH E6 GCP to the next level. This advanced eLearning course breaks GCP into four categories to enable recall, application and efficient monitoring practices in real-world challenges.

• Advanced, Basic, Intermediate
• Investigator, MCRA, PMs

Form FDA 1572: Get it Right the First Time

The Statement of Investigator (Form FDA 1572) doesn’t have to be complicated – let us help you get it right the first time. This eLearning course answers the questions of why, when and how to complete the FDA 1572 to make everyone’s jobs easier.

• Basic
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Ethics and Human Subject Protection: A Comprehensive Introduction

Explore the ethical considerations facing clinical research professionals and learn to put the rules into practice to ensure human subject safety and well-being. This eLearning course provides in-depth training on the importance of ethical conduct in clinical trials involving human subjects.

• Advanced, Basic, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

The Drug Development Process: Improving Trial Feasibility and Exploring Your Growth Potential

Develop a better understanding of the overall drug development process and how each study fits into the “big picture” of the development life cycle. This eLearning course puts into practice the ICH E8 guidance document General Considerations for Clinical Trials.

• Advanced, Basic, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA

Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance. This eLearning course will teach you risk management strategies to avoid inaccurate trial data, regulatory non-compliance and more.

• Advanced, Basic, Intermediate
• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Trainer

eResearch: Managing Clinical Trials in an Electronic Environment

Learn how to set up and manage electronic clinical research documents in compliance with U.S. and EU regulations, and current trends from both the site and sponsor perspectives. This eLearning course examines the challenges of working with electronic documents and how to overcome them.