ISO 14155 and FDA Requirements – Trials Conducted at the Research Site
December 5, 2023–Join this live webinar program as we delve into medical devices and investigational medical devices.
1
Contact Hours
Building Your Team Through Transformational Leadership in Clinical Research
December 7, 2023–This live webinar will challenge attendees to self-reflect on their own leadership practices and how those may be in need of transformation.
1
Contact Hours
Efficiency Unleashed: Optimizing Clinical Research Onboarding and Education
December 13, 2023–Clinical trial professionals with an interest or role in the onboarding and education of new staff are encouraged to attend this live webinar and learn valuable best practices from the steps taken, barriers encountered, and resources available during one clinical trial site’s journey toward realizing its goal for optimal efficiency.
1
Contact Hours
Unlearn to Learn: The Evolution of Clinical Research/Trial Training
This session discussed the current way clinical trial training is implemented and ways that it could potentially be done more effectively and efficiently by industry stakeholders.
1
Contact Hours
A Review of Medical Record Data Extraction and Adverse Event Reporting
This informative session explores some of the tools of the clinical research trade including data extraction and adverse event reporting.
1
Contact Hours
Broadening Your Approach to Trial Diversity on a Global Scale
This live webinar explored diversity through a global lens by tapping into the perspectives of industry leaders who addressed how we can broaden access to a wide range of underrepresented groups, including those who possess attributes linked to troubling and challenging health disparities.
1
Contact Hours
Merck Journeys: Elevating your Career within Clinical Research
This webinar offered a unique opportunity to learn about the rewarding career paths in CSSM. Experienced professionals from Merck shared insights into the innovative clinical research strategies, and discussed how your transferable skills can be leveraged in this field.
0
Contact Hours
ACRP Annual Membership Meeting
ACRP and The Academy leadership joined together to explore highlights of the past year and see what was planned for 2024. Attendees heard how ACRP is working for them and the clinical research profession.
0
Contact Hours
Investigator-Initiated Trial Tips and Tricks
This webinar highlighted best practices in various areas of clinical research management of investigator-initiated trials (IITs) and detailed how to navigate common challenges. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with NIH Regulations.
1
Contact Hours
Good Clinical Practice (GCP) Simulation Renewal
The New Standard in GCP Training. This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).
2
Contact Hours
Home Study: August 2023
Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.
3
Contact Hours
- Entry Level, Intermediate, Senior
- 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 Decentralized Clinical Trials (DCTs)
Gain the foundational knowledge clinical research professionals need to implement digital health components in clinical trials.
1.5
Contact Hours
Investigational Drug Services Pharmacists: What They Wish You Knew
How the Investigational Drug Services (IDS) Pharmacy utilized by your clinical trials team works shouldn’t be a mystery, when it can instead be one of your biggest allies in research. This webinar provides “insider insights” from an IDS pharmacist on facts you should have at hand about IDS services when sponsors are considering your site for studies, or are sending monitors to keep track of ongoing projects.
1
Contact Hours
How Do IRBs Review Virtual Trial Technology?
How will institutional review boards (IRBs) review study protocols involving the ever-increasing array of mobile health (mHealth) technologies and virtual trial apps on the market? This webinar helps clinical research professionals to understand the regulations and how the oversight of virtual trials might differ from what they have traditionally been used to.
1
Contact Hours
Home Study: June 2023
Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.
3
Contact Hours
ACRP 2023 Full Program – Replay
A replay package of 62 on-demand session recordings and presentation slides from the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. It includes content from the five educational tracks, the Signature Series sessions, Rapid-Fire session, and techXpo sessions, presented by a variety of clinical research service providers. Replay sessions will expire on May 31, 2026.
24
Contact Hours
ACRP 2023 Workforce Development – Replay
This package is a replay of 8 on-demand session recordings and presentation slides from the Workforce Development Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Understand the workforce landscape and gain strategies to build smarter teams.
11
Contact Hours
ACRP 2023 Technology & Future Trends – Replay
This package is a replay of 7 on-demand session recordings and presentation slides from the Technology & Future Trends Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Gain strategies to optimize technology and move your studies into the future.
7
Contact Hours
ACRP 2023 Leadership & Career Growth – Replay
This package is a replay of 10 on-demand session recordings and presentation slides from the Leadership & Career Growth Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Get the insights you need to advance your career and grow as a leader.
11
Contact Hours
ACRP 2023 Regulatory Trends & Compliance – Replay
This package is a replay of 10 on-demand session recordings and presentation slides from the Regulatory Trends & Compliance Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Hear tips and strategies to mitigate risk and keep your studies in compliance.
11
Contact Hours
ACRP 2023 Study Management & Conduct – Replay
This package is a replay of 17 on-demand session recordings and presentation slides from the Study Management & Conduct Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Learn practical, proven ways to maximize study and site performance.
18
Contact Hours
Home Study: April 2023
Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.
3
Contact Hours
2022 Site Perceptions Industry Survey Results: Actionable Insights for Sites, Sponsors, and CROs
Site leaders often feel their voices are not heard during the planning and conduct of sponsored clinical trials, while sponsors and contract research organization representatives feel at odds struggling to enhance relationships with those same sites. This webinar focuses on the results of an industry survey conducted by the Tufts Center for the Study of Drug Development on site perceptions, preparedness, and experiences with new clinical research execution solutions, and offers lessons learned on how you can improve site sustainability and lead more effective collaborations.
1
Contact Hours
I Need a Mentor: Where Do I Start?
Career success shouldn’t be measured solely by how far one is able to climb the organizational ladder, especially when reaching career goals depends on so much more than mere effort. In an environment where achievement may rely less on “what you know” than on “who you know,” identifying the right individuals to be part of your knowledge bank and support squad can become crucial.
1
Contact Hours
Building a More Equitable Future Together by Driving Inclusion in Clinical Trials
This webinar targets professionals across the clinical trial ecosystem with best practices learned about taking collective action to drive improvements focused on diversity, equity, and inclusion (DEI) issues. You will learn about building trust within historically underrepresented racial and ethnic minority communities, making clinical trials inclusive by design, and fostering partnership to address DEI-related issues in an integrated and sustainable manner.
0
Contact Hours
Building Clinical Trial Diversity Action Plans for the Future, Now
Dive into the key elements of a diversity action plan for Phase III clinical trials, as explained in the latest recommendations and requirements from the U.S. Food and Drug Administration (FDA), including considerations of race, ethnicity, age, sex, gender, geographic location, and socioeconomic status. Learn how these diversity action plans contribute to the study site’s delivery of meaningful data on drug safety and efficacy from to sponsors.
1
Contact Hours
Home Study: February 2023
Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.
3
Contact Hours
Home Study: December 2022
Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.
3
Contact Hours
A Review of ICH E8 (R1) General Considerations for Clinical Trials
The ICH E8(R1) Guideline on General Considerations for Clinical Studies from the International Council for Harmonization guides the clinical development lifecycle for experimental therapies, including quality requirements for clinical study designs and data sources. Principles and practices for the conduct of clinical trials tied to this guideline, already in effect in such regions as the U.S., Canada, and Europe and forthcoming elsewhere, will be reviewed.
1
Contact Hours
Achieving Global Health Equity Through More Diverse and Inclusive Trials
Ensuring a more equitable and accessible healthcare system starts with the healthcare professionals engaged for pre-drug launch and marketing, with the site investigators recruited by sponsors to run clinical trials, and with the location and availability of the study in terms of diverse and underrepresented populations of potential participants. Here’s a historic overview of what has been lacking in clinical trials when it comes to diversity and inclusion, how federal guidelines are beginning to turn the conversation within big pharma toward health equity, and more.
0
Contact Hours
2022 ACRP/Academy Annual Membership Meeting
Join ACRP/Academy leadership to explore highlights of ACRP’s year and what’s planned for 2023 in the areas of membership, certification, and finances.
0
Contact Hours
Home Study: October 2022
Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.
3
Contact Hours
Ensuring Quality in Fast Enrolling Trials
Are new trials coming at you with break-neck speed? This webinar reviews a case study from a fast-enrolling trial and offers strategies for maintaining high quality standards and recognizing and mitigating the risks of accelerated enrollment.
0
Contact Hours
In the DCT Journey, Every Cloud Has a Silver Lining
This webinar focuses on some of the advantages and takeaways learned so far from the introduction, implementation, and adoption of decentralized clinical trials (DCTs). Panelists explore how they operationalized best practices in the areas of budgeting, contract language, remote monitoring practices, virtual visits, and more.
1
Contact Hours
ICH E9: A Review and a Look Into the Addendum (R1)
Dive into an overview of both the ICH E9 Guideline on Statistical Principles for Clinical Trials from the International Council for Harmonization and the ICH E9(R1) Addendum, exploring how clinical trials are based on statistical principles and how treatment effects are measured.
1
Contact Hours
Understanding the Role of DMCs and EACs in Research Oversight
Take a deep dive into the roles and functions of Data Monitoring Committees/Data Safety Monitoring Boards (DMCs/DSMBs) and Endpoint Adjudication Committees/Clinical Events Committees (EACs/CECs) in the lifecycle of clinical trials. These committees are increasingly tasked with providing independent, expert evaluations of clinical trial events and unbiased adjudications to determine if the definitions of certain clinical trial events have been met.
1
Contact Hours
Everything You Need to Know About Holding an IND
This webinar provides a review of the purpose of and expectations set for holding an Investigational New Drug (IND) application through the U.S. Food and Drug Administration, explores common IND-related errors and how to avoid them, and outlines related requirements found in 21 CFR 312 of the Code of Federal Regulations for IND maintenance.
1
Contact Hours
Deconstruct Your Clinical Trial to Plan a Positive Outcome: Effective Planning and Communication Strategies
This webinar examines the communication of intent and expectations to stakeholders in clinical trials to minimize risk and gain fluidity in operations, along with key elements behind planning a clinical trial and best practices for budgeting a study.
0
Contact Hours
Streamline Your Clinical Research Organization’s Processes with End-to-End Promotions
Presenting a discussion on how consolidating the processes involved in the phases of drug discovery, pre-clinical research, clinical trials, and post-approval expectations on a single platform drives efficiencies, margin improvements, and real-time collaborations internally and externally. The result is better top- and bottom-line financial performance and consistency in process outcomes during trial execution.
0
Contact Hours
Best of ACRP 2022
The “Best of ACRP 2022” package offers recordings from 25 of the most popular sessions from our most recent in-person event, along with seven techXpo sessions, presented by a variety of clinical research service providers.
26
Contact Hours
Eliminating Barriers to Careers in Clinical Research
A perfect storm of negative trends is putting immense pressure on entry-level hiring, retention, and overall satisfaction and growth in the clinical research workforce. This webinar focuses on recognizing and overcoming the challenges that are unnecessary barriers to greater participation in the workforce by promising talent from a range of backgrounds and experiences.
0
Contact Hours
- Entry Level, Intermediate, Senior
- 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 New Work Life Balance in Clinical Research
There’s no denying that “work as usual” has gone out the window in recent years–in the clinical research workforce as well as in most other settings. This webinar explores strategies for juggling a career in clinical research and your personal life in the “new normal,” including in the arenas of excelling at time management in the office and at home, reaching an ideal work/life balance, and acquiring tools to help make your goals a reality.
1
Contact Hours
Virtual ACRP 2021 Full Program Replay
ACRP 2021 programming delivers practical strategies, best practices, and creative solutions needed to improve clinical trial quality.
26
Contact Hours
Virtual ACRP 2021 Innovation in the Era of COVID Track Replay
Unlock your potential by learning innovative new ways clinical research is being conducted in response to COVID-19. This online, interactive program addresses telemedicine, remote monitoring, team management, study start-up and more in the era of COVID.
6
Contact Hours
Virtual ACRP 2021 Regulatory Trends & Compliance Track Replay
Mitigate risk and improve regulatory compliance with insider advice from FDA officials and industry experts. This online, interactive program features FDA officials and industry experts addressing CDER BIMO compliance and enforcement, FDA inspections, ClinicalTrials.gov requirements, and more.
9
Contact Hours
Investigative Site Diversity: Tufts CSDD Study on Staff Diversity at Clinical Research Sites
In this webinar, the Tufts Center for the Study of Drug Development team shares survey results on staff diversity at clinical research sites, with an emphasis on the impact diversity has on site performance and its practical implications, the major factors noted for diversity-related success and their associated barriers, and the relationship between site diversity and patient diversity.
1
Contact Hours
The Push for Technology: A Discussion of Implementation Struggles, Strategies, and Lessons Learned
This webinar features a panel discussion on how the pandemic pushed the implementation of new technologies for clinical trials, with a site-centric focus on the struggles overcome and lessons learned, along with the impact on the workforce and how we all may want to prepare for the future.
1
Contact Hours
Best Practices for Communicating Benefit, Risk, and Uncertainty in Medical Device Clinical Trials
This webinar focuses on how research participants cannot make an informed decision to participate in a clinical trial without clear communications from the research professionals supporting the trial. Evidence-based practices are covered to help you conduct patient education and informed consent tied to the benefits, risks, uncertainties, and patient preferences for using new medical technologies.
1
Contact Hours
Using Agile Strategies to Solve Challenges in Research Operations
This webinar looks at how being agile in research settings is becoming a key performance indicator that partners and sponsors are seeking and expecting from sites, with a focus on techniques and strategies you can use to address and solve administrative and operational challenges at a faster rate via pragmatic and thoughtful “big swings of bold.”
1
Contact Hours
Virtual ACRP 2021 Operational Efficiencies Track Replay
Boost efficiency in clinical trial management and execution with practical strategies for sites, sponsors, and CROs. This online, interactive program addresses collaboration, protocol feasibility, decentralized trials, remote monitoring, and more.
11
Contact Hours
Clinical Research Staffing Reprioritizations and Resourcing Strategies
This webinar presents lessons learned from a survey on the impacts of the pandemic on staffing at research sites, and discusses implications for the future of clinical research workflows from the current shift to remote operations. When should you look for help or change your staffing approach?
0
Contact Hours
The Future of DCTs: Are You Prepared?
This webinar is tailored for research professionals in sponsor, contract research organization, and study site settings who wonder how to embrace the challenges and benefits of decentralized clinical trials (DCTs), and includes a practical guide for what DCTs really are, how there is no going back, and how it is up to the research professional to adapt to change.
1
Contact Hours
Research Ready: Leveraging Technology in the New Research Landscape
Join Advarra experts in a discussion on how to leverage technology in the new research landscape
0
Contact Hours
Working with Site-Based Paperless Solutions and Ensuring Audit Readiness
Join RealTime experts for an overview of site-based electronic systems that the research industry is rapidly adopting.
0
Contact Hours
Achieving Regulatory Compliance via Collaboration: Technology and Site Perspectives
Join experts from WCG Velos and the University of Kansas Medical Center to learn top practices and processes sites follow to meet compliance standards.
0
Contact Hours
Communication Strategies for Conflict Resolution in Clinical Research Teams
This webinar examines group dynamics, team function, and how conflicts arise within the research team, and considers how specific communication behaviors can foster effective conflict resolution that facilitates team growth.
1
Contact Hours
Career Paths in Clinical Research: Sharing the Journey and Providing Insight
Join a panel of clinical research professionals as they discuss their career paths into and through the clinical research industry, consider the future of their roles, and share advice with those wanting to join the industry. You will gain an understanding of the different research roles, areas that are ripe for career growth and development, and how you can prepare to thrive amidst future trends.
1
Contact Hours
Let’s Talk Patient Recruitment: Strategies, Tools, Communication
This webinar reviews two participant recruitment strategies with guests who have helped increase efficiencies and increase recruitment into clinical trials. Be prepared to walk away with some new tips and tricks that you may be able to implement into your recruitment strategy as well.
1
Contact Hours
Clinical Trial Diversity: Strategies to Support Patients, Sites, and Sponsors
This webinar focuses on ideas for educational outreach to promote the purposes and value of clinical research within organizations and communities, and considers what measures sponsors and sites can take to engage diverse patients in their clinical trials.
1
Contact Hours
Monitoring Investigator-Initiated Trials
This webinar offers organizations valuable knowledge regarding how to create a process for internally monitoring the quality and safety of investigator-initiated trials. Templates, workflows, and other tools are shared so that learners may adapt the proposed program to their own institutional needs.
1
Contact Hours
Improving Technology Proficiency in Clinical Research
This webinar considers how sites are shifting away from sponsor-provided systems into technology that meets their business needs. As the options for technology solutions continue to grow, research sites must develop a true technology strategy and develop proficiencies in selecting, implementing, maintaining, and connecting their technology.
1
Contact Hours
How to Build Advanced Workflows with an Integrated Technology Environment
Join Florence Healthcare to learn how to harness the power of best-in-class software while avoiding digital fatigue, duplication, and wasted time.
0
Contact Hours
Quality Improvements as a Result of Paperless Site-Based Systems
Join RealTime CTMS to examine how paperless sites and site networks are driving quality and improved timelines for the clinical research industry.
0
Contact Hours
Exit the Feature Battle: How to Think Long Term and Prepare Your Site for the Future of Technology in Clinical Research
Join Veeva Systems to explore the key qualities and features sites need to look for in their technology partners to increase their connectivity with sponsors and patients.
0
Contact Hours
Research and Expanded Access in Pandemic Times
This webinar provides an overview of the mechanisms through which, in pandemic conditions, experimental COVID-19 therapies and diagnostics were made available to patients and providers before clinical trials had established whether those products were safe and effective. Also considered are how this state of affairs affected researchers’ ability to generate substantial evidence of product effectiveness through high-quality trials and the U.S. Food and Drug Administration’s deliberations over potential COVID-19 vaccines.
1
Contact Hours
Good Clinical Practice (GCP) Simulation
The New Standard in GCP Training. This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).
2
Contact Hours
eSource: Why This is the Platform of the Future
Join experts from Clinical Research IO to explore how several independent trends in research will make eSource a platform technology for sites.
0
Contact Hours
The Impact of Brexit and COVID-19 on Clinical Research Data Processing in the EU/UK
Join The DPO Centre for this exploration of data protection challenges relating to the handling of sensitive personal data of EU and UK trial participants and how COVID-19 has bought data protection to the forefront of people’s minds.
0
Contact Hours
Continuing Organizational SOP Needs to Maintain Compliance (Session I)
This is the first of two webinars offering a deep dive into transforming operational effectiveness by utilizing three key areas in drafting your clinical research standard operating procedures (SOPs) so they are specific, meaningful, and productive for your unique research organization. The stages of the SOP life cycle will be explored beyond merely drafting procedures to include training and enforcement for them as well.
1
Contact Hours
Transforming SOP Infrastructure for COVID Times (Session II)
This second of two webinars on best practices in crafting standard operating procedures (SOPs) for clinical trials applies the concept of emotional quotient-based design thinking to appropriately draft SOPs that include all potential stakeholders. Also considered will be common blind spots within basic compliance mechanisms and the keys for drafting more adaptive SOPs to serve as reference tools and training materials for preparing your organization for new ways of conducting clinical trials.
1
Contact Hours
SARS-Cov-2, the Law, and You
In this webinar, the Association of Clinical Research Professionals and the Society for Clinical Research Sites offer a collaborative discussion on how new laws and regulations arising from the COVID-19 pandemic conditions affect small clinical research sites.
0
Contact Hours
COVID-19 Technology Mad-Dash, What Worked and What Didn’t?
This webinar addresses the challenges of transforming clinical research operations with technology built during the upheavals research sites underwent in the midst of COVID-19 disruptions. You will gain a better understanding of the technology evolution experienced by the clinical research enterprise, how best to future-proof operations to avoid future disruptions such as this, and tips for operating your site with a view of both short- and long-term goals.
1
Contact Hours
Innovative Approach of Using EHR Data to Improve the Speed, Efficiency, Quality and Costs of Conducting Clinical Trials
This webinar describes how a research site’s electronic health record (EHR) data can be used to precisely identify potential subjects from its patient population, thus reducing recruitment and screening efforts and accelerating time to completion of enrollment. Involved are the use of eConsent to enroll patients from their homes, the collection and use of relevant real-world data extracted from the EHR in ways that eliminate certain study visits and manual data entry, and the use of eSource for cutting the need for source data verification.
1
Contact Hours
Practical Tips for Career Development
This webinar describes techniques for developing yourself as a better leader, as well as tools for developing a strong team that fosters open communication and respect of different personality styles. It provides practical tips for developing career ladders for individuals who wish to grow, hints on how to be flexible in terms of your team’s work environments and scheduling, and lessons learned on how to interact with external teams in order to facilitate strong inter-departmental communications and work flows.
1
Contact Hours
Building Relationships With Healthcare Professionals and Community Groups to Increase Enrollment
This webinar focuses on best practices for building and maintaining relationships with healthcare professionals and community groups to increase study enrollment, particularly among diverse patient populations. You will learn how to manage productive physician and community networks that result in highly qualified patient referrals through real-world examples of successful site efforts, and from recommendations on practical adjustments sites can make to their existing strategies to maximize their efforts without overburdening their schedules.
1
Contact Hours
Diversity of Research Personnel: Knowing Who We Are to Know Who We Serve
This webinar highlights how lack of diversity in the recruitment of study subjects impacts the generalizability of research findings, and how evaluating diversity among your research team members will inform study design and recruitment strategies. In turn, this will increase diversity among recruited subjects and make research findings more broadly applicable to wider populations.
1
Contact Hours
Informed Consent Simulation
This interactive, simulation-powered training program helps ensure informed consent is obtained by the right subject, with the right forms, by the right people, through the right process, at the right time, and with the right documentation.
2.0
Contact Hours
ACRP Clinical Research Knowledge Assessment™ (CRKA)
Whether you’re an emerging professional looking to demonstrate your foundational knowledge to prospective employers or an organizational leader looking for an efficient, effective way to vet new hires, ACRP’s new Entry-Level Knowledge Assessment (ELKA) is for you.
0
Contact Hours
Certified Quality Manager Training
Increase your influence and expand your career opportunities by validating your commitment to quality. The Quality Management Institute and ACRP have partnered in a program of education for individual professionalism and the quality management of clinical research sites.
0
Contact Hours
- Entry Level, Intermediate, Senior
- BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer
Clinical Trial Monitoring Basics
Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?
1.5
Contact Hours
- Entry Level, 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.
1.5
Contact Hours
- Entry Level
- Investigator,
Investigator Responsibilities
Learn the various responsibilities of clinical investigators based on FDA Regulations, ICH Guidance Documents, and international standards.
0
Contact Hours
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.
1.5
Contact Hours
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.
1.5
Contact Hours
- Entry Level
- 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.
1.5
Contact Hours
- 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.
1.5
Contact Hours
- Entry Level
- 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.
0
Contact Hours
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.
1.5
Contact Hours
- Entry Level, Intermediate, Senior
- 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.
1.5
Contact Hours
- Entry Level, Intermediate, Senior
- 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.
1.5
Contact Hours
- Entry Level, 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.
1.5
Contact Hours
- Entry Level, Intermediate, Senior
- 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
Statistical Principles for Clinical Trials: Overview of ICH E9
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.
1.5
Contact Hours
- Entry Level
- 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
An essential course for all clinical research professionals involved in the clinical trial agreement and/or budget process for industry-initiated trials.
1.5
Contact Hours
- Intermediate, Senior
- 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.
1.5
Contact Hours
- Intermediate, Senior
- 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.
2
Contact Hours
- Entry Level, Intermediate, Senior
- 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.
1.5
Contact Hours
- Entry Level
- 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.
5
Contact Hours
- Entry Level, Intermediate, Senior
- 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: ICH E8(R1) General Considerations for Clinical Trials
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.
1.5
Contact Hours
- Entry Level, Intermediate, Senior
- 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.
1.5
Contact Hours
- Entry Level, Intermediate, Senior
- 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.
1.5
Contact Hours