Clinical Research Professional Courses

Program Description: Intermediate- Learner Level

This program, comprised of five courses, features industry and academic experts discussing the role and impact of technological advancements in the medical device industry.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (5.5 Total Contact Hours).

Courses:

1. What is Digital/AI/Machine Learning? How is it Used?
2. Clinical Virtual Reality: Seven Ways that Virtual Reality Will Change the World of Mental Healthcare!
3. Regulatory Framework for the Digital World
4. Use of AI in Drug Development
5. Cybersecurity

Program Description: Intermediate- Learner Level

Principal Investigators and regulatory professionals must stay abreast of legal requirements and compliance strategies when conducting clinical trials.  This symposium offers perspectives from attorneys and regulatory experts to discuss U.S. and international regulations for pharmaceutical, biologic and medical device organizations, as well as sponsored and investigator-sponsored trials.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 6-course program and earn a badge (6.5 Total Contact Hours).

Courses:

1. Investigator Responsibilities: Industry Sponsored Trials
2. Investigator Responsibilities: Investigator Initiated
3. Clinical Trials Contracts
4. Legal Considerations of Compassionate Use
5. Liability and Indemnification
6. Privacy and HIPAA: Concerns in Global Clinical Trials

Program Description: Beginner- Learner Level

Demonstrating the safety and effectiveness of new medical devices is a critical part of the medical product development process and requires significant resources to accomplish. This program provides perspectives from physicians and medical device experts to discuss the complex regulatory process of various medical device classifications, U.S. and international requirements, trial management, and pediatric needs within the framework of Good Clinical Practices. At the end of this program, participants will understand the various types of medical device classification and regulatory requirements, and gain knowledge of coordinating, monitoring, and managing a medical device clinical trial.

Complete a course(s) and earn a continuing education certificate. Additionally, complete 5 of 7 courses in this program and earn a badge (4-7 Total Contact Hours).

Courses:

1. History, Terms, Definitions & Regulatory Requirements
2. IRB Reviews on Medical Device Trials
3. Quality at the Data Level
4. Medical Device Feasibility Clinical Trials - A Medical Case Study
5. Advanced International Trials with Medical Devices
6. Auditing of Medical Device Trials
7. Gaps & Opportunities in Pediatric Medical Device Trials

Program Description: Intermediate/Advanced - Learner Level

Clinical trial data is critical to evaluating a medical product’s efficacy and safety and must be of sufficient quality and reliability to ensure valid analyses. The clinical trials enterprise has historically linked the gathering of more data with trial quality, ‘more is better”. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but also that data must be entered, reviewed, scrutinized, queried, and validated multiple times during the life cycle of a trial. This concept of over-collection and analysis is so entrenched, it is considered risky by investigators not to collect ever-increasing volumes of data and metadata. Growing evidence suggests a myopic focus on the accuracy of each data point, regardless of its criticality, adds little value (if anything) to trial quality and safety and, in fact, adds to a trial's significant expense and effort. This has prompted interest in more tailored approaches that are informed by trial design and how trial conduct influences quality. This program introduces Quality by Design (QbD) as a systematic approach to medical product development to ensure trial quality by applying analytical and risk-management methodologies to the design, development, and manufacturing of products.

Complete a course(s) and earn a continuing education certificate. Additionally, complete 5 of 5 courses in this program and earn a badge (5.5 Total Contact Hours).

Courses:

1. What Do We Mean by Quality by Design
2. Clinical Trials Transformative Initiative (CTTI): Approach to Quality by Design
3. Developing Quality by Design tools for Clinical Researchers
4. Integrating Quality by Design into Team Science & Project Management for Research Success
5. Applying Design for Six Sigma

Program Description: Intermediate/Advanced - Learner Level

This program provides an overview of real-world data (RWD) and real-world evidence (RWE). Collected through the routine delivery of health care, RWD and RWE are potentially powerful tools for enhancing the quality and efficiency of clinical trials and precision medicine.  Traditionally, data from randomized clinical trial have been viewed as the gold standard in drug development.  Over the last decade, new sources of data and innovative technologies have accelerated the shift toward individualized care and precision medicine, whereby providers can develop treatment plans targeted to specific patient needs and improved outcomes.  Made possible by the number of U.S. Food and Drug Administration acts and developments, regulators and pharmaceutical developers have begun to view real-world data (RWD)/real-world evidence (RWE) as a more efficient way to evaluate drug approval and label expansion decisions. In this program, the concepts and development of RWD/RWE will be explored, including its usefulness in rare diseases, insights, and challenges in data validity, and how RWD/RWE can accelerate clinical trials and the integration of precision medicine within standardized care.

Complete a course(s) and earn a continuing education certificate. Additionally, complete all 5 courses in this program and earn a badge (5.25 Total Contact Hours).

Courses:

1. Patient Centered Drug Development: History, Terms, & Definitions
2. Patient-focused Drug Development: Patients & Patient Advocacy Organizations
3. Introduction to Rare Diseases & Orphan Drugs
4. From Data to Information to Knowledge
5. Case Study: From Discovery to Practice & Survivorship

Program Description: Beginner/Intermediate - Learner Level 

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other drug related issues. To accurately assess the risk of potential harms, the FDA and other regulatory agencies developed broad sets of regulations and procedures that govern how researchers, and the biomedical industry must gather, analyze, and report adverse events. This program explores the fundamentals of pharmacovigilance for drugs, medical devices and biologics including adverse event reporting and regulatory requirements, risks management, and case studies demonstrating practical approaches to adverse event reporting.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 6-course program and earn a badge (4.75 Total Contact Hours).

Courses:

1. Regulatory Requirements
2. Safety Reporting in Investigator-Initiated Trials
3. Safety Reporting from Other Sources
4. Safety Reporting in Industry-Sponsored Trials and Case Studies – Part 1
5. Safety Reporting in Industry-Sponsored Trials and Case Studies – Part 2
6. Adverse Event Reporting

Program Description: Beginner/Intermediate/Advanced - Learner Level

Inspired by current events unfolding worldwide, this program provides in-depth discussions on diversity, inclusion, and equality in human subjects research, and the importance of representation in clinical trials, especially in the time of COVID-19. Disease pattern, clinical presentation and therapeutic response can vary dramatically based on several factors including race, ethnicity, genetics, comorbidities, socioeconomic status, gender, etc.  Clinical trials are necessary in the advancement of new therapies. While many individuals decide to participate, racial and ethnic minorities remain consistently underrepresented. It is vital to understand the significance of diversity in clinical trials, the barriers and facilitators to participation, the importance of community engagement, and education about clinical trials to ensure representation of clinical trials results relevant to diverse populations.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 6-course program and earn a badge (5.0 Total Contact Hours).

Courses:

1. What Do We Mean by Diversity in Clinical Trials?
2. FDA Initiatives to Address Diversity in Clinical Trials
3. Clinical Trials Participation: Understanding the Needs and Importance of Diverse Populations
4. Diversity, Equity, and Inclusion in Clinical Research
5. Population on the Fringe of Clinical Trial Enrollment
6. Ensuring Participant Diversity and Engagement during COVID-19

Program Description: Beginner - Learner Level

Clinical trials play a pivotal role in evaluating new interventions to prevent or treat disease in humans. The regulatory environment and strategy drive the development of drug and medical devices including design of clinical trials/programs. Topics include principles and methodologies used in study design, implementation, and analysis of clinical trials, ethical issues from medical device development, and an overview of the FDA’s evolution to become the nation’s leading authority for regulatory oversight. All study design elements including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III and Phase IV studies will also be explored.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (5.35 Total Contact Hours).

Courses:

1. Key Regulatory Terminology in Clinical Trial Design
2. Evolution of FDA’s View of a Well-Designed Clinical Trial
3. Classical and Novel Designs Used in Regulatory Approvals
4. Unique Designs for Medical Device Trials
5. Case Studies and Future Trends

Program Description: Beginner/Intermediate/Advanced - Learner Level

There are thousands of job opportunities in clinical research. For those seeking an initial career in this field or switching professions, how does one “get their foot in the door”? In this program, experts from the medical device industry and academic medical institutions will provide comprehensive insights into various clinical research fields, and necessary core competencies for professional growth and pathway advancement. At the end of this program, participants will gain perspectives and insights in various clinical research fields, and the required skill sets, background experiences, education, and resume building skills to acquire positions as a clinical research professional.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (4.25 Total Contact Hours).

Courses:

1. From Academics to Industry – A Physician Research Perspective
2. Clinical Supply Chain Management: Dude, Where’s My Patient Benefit?
3. Understanding Clinical Research Management at Academic Institutions  
4. Roads to the Human Subjects Protection Program (OPRS and IRB)
5. Knocking on HR’s Door: Do you have what it takes to be a CRP?

Program Description: Beginner - Learner Level

This 4-part program builds learner knowledge and expertise in the interpretation of Clinical and Translational Research (CTR) literature using written and supplemental materials, videos, interactive graphics, and self-assessment.

• Part 1: Understanding the Translational Science Research Ecosystem
• Part 2: Basic Concepts Defining the Analytic Approach to Research
• Part 3: Elements of Clinical and Translational Research Studies
• Part 4: Clinical and Translational Research Study Design Types

Complete the 4-part program and earn a continuing education certificate. (6.0 Total Contact Hours).

Development of this program was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award number UL1TR002378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Courses/Program: 

1. Introduction to Clinical and Translational Research

Program Description: Beginner - Learner Level

This 6-course program explores the regulatory, scientific, and logistical considerations in clinical trials involving emerging technologies, cutting-edge devices, immunotherapies, gene therapies, and stem cell therapies.

Rapid advances in science over the past decade have provided new technologies to innovate, manufacture and assess novel medical products, and to the discovery of life changing cures. Regulators have a key role in providing guidance to industry to ensure safe and effective use of these new scientific advances. In this program, scientific achievements will be highlighted along with their real-world impact. Consideration will be given to regulatory and logistical operations, and successes and consequences of failure.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 6-course program and earn a badge (6.25 Total Contact Hours).

Courses:

1. Regulatory Considerations
2. Gene Therapy Trials and Tribulations 
3. Clinical Trials for Stem Cell Therapies
4. Clinical Trial Enabling Technologies – Decentralized Clinical Trials
5. Immunotherapy Trials
6. Cutting Edge Technologies and Humanitarian Devices

Program Description: Intermediate/Advanced - Learner Level

This 5-course program features industry and academic experts discussing the integral role of statistics in medical product development, specifically in clinical trial design. This program provides a foundational understanding of statistical topics related to clinical research in an interactive forum. Statistical principles such as power, multiplicity, and P-values remain critical in designing successful clinical trials. Statistical techniques determine the number of patients needed for a study to meet a pre-set clinical endpoint and to generate meaningful results. While analyses can reveal mathematically significant, this does not always equate to clinical or medical value.

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (4.1 Total Contact Hours).

Courses:

1. Basic Statistical Principles: Validity and Sample Size
2. Designing Medical Devices
3. Pediatric Trials
4. CTSI Clinical Study Design Types
5. Gender, Race, and Ethnicity in Clinical Trials

Program Description: Intermediate/Advanced - Learner Level

This program is comprised of five courses featuring industry experts discussing the role of genomics in medical product development, a rapidly evolving field of science with new technologies and emerging applications.

Genomics science continues to play a major role in generating new knowledge in the basic research arena. How these learnings translate into product development involves the integration of genomics data, including pharmacogenomics and “Big Data,” and data extraction for mathematical models, such as drug-disease-trial models, into the regulatory decision-making process. This program will introduce and examine these topics in an interactive forum with an emphasis on innovation and translation. This course is designed to increase understanding of regulatory framework and policies for FDA regulated genomics products. 

Complete a course(s) and earn a continuing education certificate. Additionally, complete this 5-course program and earn a badge (5.75 Total Contact Hours).

Courses:

1. Genomics and Regulations
2. Genomics and Personalized Medicine
3. Pharmacogenomics Considerations for Clinical Research and Implementation
4. Big Data and Genomics
5. Applied Genomics and Target Identification