There will be a $60 fee upon acceptance into the program
A basic overview of medical terminology is essential to many fields within healthcare-related industries. Using an anatomy and physiology systems approach, this textbook-based course reviews common terms associated with healthcare delivery and medical record-keeping, as well as medical research and development. Upon completion, students are better prepared to work in healthcare or biomedical environments. Students complete the course within the 4 week section in which they are enrolled.
This keystone course examines the drug development process and history of clinical trials. Topics include sources of new drugs & devices; the process of discovery; how a discovery becomes a drug or device; the definition, phases, and purposes of both pharmacological and clinical development; the history of drug/device regulation and effects of historical events on regulatory oversight; investigative new drug applications; and premarket approval applications.
This essential course offers an ethical framework for human subjects regulations, introduces regulatory issues in clinical trials, and reviews concern for human subjects protection in drug/device trials. A mock IRB meeting applies the principles learned.
Topics include the definition and identification of good clinical practices (GCPs); how GCPs affect the conduct of clinical trials; regulating agencies and applicable regulations from the Code of Federal Regulations and ICH guidelines; state regulations; obligations of investigators, sponsors, monitors, and IRBs; compliance and accountability during clinical trials; protocol violations and deviations; consequence of falsification of data and/or patient records; and the blacklist. Device regulations also covered.
14 units are required
This advanced-level course reviews the science that forms the basis for effective clinical trial design. Topics include classifying and describing trial design by stage in drug/device development; types of trial designs; defining the hypothesis and study objectives; safety information and DSMBs; determining the population and sample size; study procedures; identifying and selecting clinically meaningful endpoints; scientific/ethical considerations; and statistical validity of design, execution, analysis, and reporting.
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.
Common issues and concerns associated with drug safety surveillance within the clinical trial are the focus of this course. Topics include the defining and identifying 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 start your career in clinical research.
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. In this course, participants will discuss and practice the basic principles of clear medical writing and study the rules governing effective clinical trial documentation. Prerequisites: Medical Terminology, Drug Development Process, and GCP courses, or proven mastery of content.
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 cancer, as well as basic principles, treatment modalities and potential effect of those treatment modalities.
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; tumor assessments; assessing and grading toxicities; cancer-specific SAE; & SAE reporting.
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.
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.
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 regulations to institutions that are either trying to develop clinical trial materials or commercial product for human or veterinary treatment to assure compliance. Teaching the foundation of current Good Manufacturing Practices and similar legislative edicts in other countries that are applied to Chemistry Manufacturing and Controls (CMC) in the biotechnology, pharmaceutical and nutritional supplement industries should provide that knowledge base.
Understand the FDA's basic Good Manufacturing Practices regulations
Understand the historical evolution of current Good Manufacturing Practices
Understand the regulatory structure of other countries that follow GMPs
Understand the application of guidance documents to the GMPs (ICH and FDA)
Develop a basic Quality Management System to manage GMPs
Use risk management tools in developing a compliance strategy
Respond with solutions to practical case studies as a learning tool.
Examine the elements involved in implementing and monitoring a clinical study from the sponsor's point of view. Topics include finalizing the study materials; site selection; staffing and training; strategies for communicating with sites, regulators, and others; cost management; site initiation; enrollment options; data management set-up and testing; monitoring procedures and training; auditing; safety monitoring; reports; and the Data and Safety Monitoring Board (DSMB).
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 procedures; patient confidentiality; and ICH Guidelines (21 CFR
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.
Learn to assist the clinical study site in recruiting appropriate patients for a clinical trials study, including oncology trials. Topics include targeting the appropriate study population; resources for identifying potential patients, using web tools and products; marketing and advertising strategies and tactics; ethical considerations and FDA/ICH guidelines; and retaining study patients.
As new clinical studies are designed and managed, each study should begin in a well-organized, well-planned manner. This online course assists the clinical study site in preparation for a new clinical study. Topics include identifying the research team, roles and responsibilities of the study coordinator vs. investigators, preparing for a prestudy site visit, review of study protocol, preparing the IRB application, setting up study files and the regulatory binder, and site initiation.
Designed to illuminate the financial management of a trial from the sponsor perspective, this survey course includes prioritization of spending, costs involved in conducting a clinical trial (costs incurred by the trial sponsor), how to set up a per-site budget, how to determine a total trial cost, and how to control & limit all of the above.
This course is designed for the physician who wants to enter the clinical trials arena. Topics include: the benefits and responsibilities of conducting clinical trials, choosing an appropriate trial for your practice, recruiting and enrolling participants, and ensuring data integrity.
This course examines the economic factors that must be considered when pursuing the development of a drug/device. Topics include the definition of health economics; points in the development process at which economics must be considered; alternative study designs; determining costs; choice of comparator therapy; and economic analysis procedures; and decision making.
The student consults with the instructional advisor to identify and secure an appropriate preceptorship assignment, fulfilling at least 20 hours of work associated with that assignment, writing a paper that summarizes their experience and learning, and reviewing their findings with both the instructor and the sponsor.
Advanced Nuts and Bolts Monitoring of Clinical Trials is a hands-on interactive live course that demystifies advanced site management and monitoring of clinical trials. Learn various data collection methods (e.g., remote data entry, facsimile, or de-coupled case report forms) including data queries and cleaning. Students will learn how to deal with difficult sites, problem solve, work with multiple priorities & projects, and identify & work with serious safety issues. Detecting fraudulent data is a strong focus, along with communication and time management exercises. Enroll in this course after completing all required courses plus 12 elective units, and be ready to start your career in clinical research.
Please review the prerequisite information above for specific details.
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Healthcare & Behavioral Sciences. Call 858-534-9261 or Email: email@example.com
Please see the application for specific admission requirements for this program. Although a college degree or professional experience in the field are not required, applicants with such experience may receive preference for admission when program capacity is limited.
Those pursuing the Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRA) credentials through ACRP, or the Clinical Research Professional (CCRP) credentials through SoCRA, can fulfill educational requirements by completing this program. For information about ACRP certification, please go to http://www.acrpnet.org. For more information about SoCRA certification, please go to http://socra.org.
Scripps Office for the Protection of Research Subjects
Aerotek Scientific LLC
UCSD Health Sciences Research Compliance Program
JD, CHRC, CHC, CCRA
Clinical and Translational Research Institute (CTRI), UCSD
Naval Medical Center, San Diego
Rady Childrens Hospital SD
Universidad de California, San Diego - ExtensiÃ³n
MedVenture Consultants, Inc.
There will be a $60 fee upon
acceptance into the program
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