Clinical Trials Design and Management

This course reviews the nuts-and-bolts of effective clinical trial design and the basic anatomy of a clinical trial. Topics include trial designs by stage in drug/device development; the various types of trial designs and when they apply; defining the hypothesis and study objectives; defining clinically meaningful safety and efficacy endpoints and study procedures; selecting the study population and determining sample size; scientific/ethical considerations; and data analyses and statistical considerations.

Common issues and concerns associated with drug safety surveillance within clinical trials are the focus of this course. Topics include the defining and identifying of adverse experiences, verifying drug safety, regulations regarding surveillance of investigational and marketed products, safety reporting requirements, analyzing study results to determine safety, and required actions in the event of safety issues. Useful from both site and sponsor perspectives.

See the Site from the Sponsor's perspective: important for both monitors and coordinators. Topics include responsibilities of sponsors and investigators; qualifying investigators; regulatory document review; study initiation; routine monitoring tools, documents, and techniques; closeout visits; site management; and handling difficult situations.

This is a hands-on interactive live course, demystifies advanced site management and monitoring of clinical trials. Learn how to deal with difficult sites, problem solve and work with multiple priorities and projects, and identify and work with serious safety issues. Detecting fraudulent data is a strong focus, along with communication and time management exercises. Career opportunities in clinical research along with recommendations for drafting resumes and next steps will also be covered. Enroll in this course after completing all required courses plus 12 elective units, and be ready to...

Concepts of cancer treatment and management will be communicated to the student through a series of web-based sessions, with a sharp focus on the terminology, pathology, diagnostics, disease management. Intended for individuals with educational backgrounds in biological sciences at the associates, bachelor or masters level. Nurses, research assistants, data managers and others who are involved in oncology research or would like to become involved in this area of research and development would benefit from this course. Included: an overview of cancer biology, diagnosis and specific types of...

This course presents the statistics essentials for the non-statistician involved in clinical trials. Topics include study designs, hypothesis testing, sample size calculations, assumptions, controls, endpoints, data management principles, data presentations and analysis plans, methods for analysis, and conclusions.

No clinical trial can begin until a protocol has been written, and no clinical trial is complete until the final report is assembled, signed, and submitted to the FDA. Good documentation for clinical trials must be clear and scientifically sound, and it must conform to instructions. This course provides an overview of key regulatory documents; their central purpose and content; and the regulations and/or procedures that govern them. Students will also have the opportunity to review, write, and discuss different aspects of regulatory documents. The course is intended for individuals who want...

Monitoring oncology clinical trials requires advanced skills, including understanding and maintaining complete regulatory documents; protocol & data integrity; patient safety; and the successful completion of the clinical trial within the sponsor’s/CRO’s and medical site’s goals, all within the framework of good clinical practices (GCPs). Students are exposed to key regulatory documents, IND safety reports, MedWatch reports, various IRB submissions/requirements, and federal guidelines. Also covered: responsibilities of clinical research personnel; correlation of concomitant medications;...

This course reviews the breadth of U.S. and international regulations associated with the development of drugs, biologics, medical devices, and diagnostics. Topics include a review of regulatory agencies and the role/responsibilities of each; pathways for regulatory applications; important differences between development processes in the U.S. and those of other countries; and the impact of regulatory approval processes on corporate strategy.

Gain a comprehensive understanding in FDA compliance with current good manufacturing practices (cGMPs), as regulated and guided by national and international agencies for the pharmaceutical and industry. The course will emphasize the US FDA cGMPs and briefly touch on differences between the other regional markets in the rest of the world. In addition to pharmaceutical applications, nutritional supplements will also be discussed since this industry is held to standards very similar to therapeutics. The goal of this course is to teach you how to apply the knowledge gained about GMP...

This course provides a step-by-step outline of internal and external audits as well as ongoing actions that should be taken to prepare for an audit. Topics include types of audits; the audit process (sites, sponsors, CROs); planning/preparing for an audit; rules of behavior during and after the audit; and dealing with the results.

By addressing fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Practice regulations, this course will show how GLP's affect the conduct of non-clinical laboratory research, QA audit programs and FDA inspections. You will gain an in-depth understanding of specific critical GLP requirements such as the role of the QAU, study director, test and control articles. Preparation for FDA GLP inspections and current inspection trends, basic elements of GLP documentation, and considerations for lab facilities, equipment, and animals are covered.

It has become increasingly more important to use solid project management principles when managing clinical trials. This course teaches the basic skills of project management derived from PMI principles but with focus on clinical trials. Plenty of situational examples will be provided in order to maximize understanding and clarity. Topics include a brief history of the Project Management Institute (PMI), key terms and definitions, detailed review of process groups, knowledge areas and their linkage to project management process groups, multiple tools and templates that can be utilized...

This course is designed to assist clinical trials sponsors to design data capture methods, and to organize and manage clinical trial data collected from one or more investigative sites. Topics include data flow from site to sponsor; case report form (CRF) design, database structures; database management systems including validation, backup, security and electronic data capture (EDC) systems; data capture techniques, data transfer and uploads; data quality methods including data entry, data review and programmatic checking, CRF-to-database audit procedures; analysis-ready database...

This course is intended to help a clinical study sponsor recruit the appropriate sites and investigators for the study. Topics include sources of information on sites and investigators; approaching and evaluating the potential investigator and the potential site; and understanding the application of good clinical practices.

This course provides the clinical study sponsor strategies for working with a clinical research organization (CRO) to conduct the study. Topics include assessing internal capabilities and limitations, evaluating and selecting an appropriate CRO partner, transferring responsibilities to the CRO, costs and benefits of a CRO relationship, delineating expectations, and managing the relationship.