Clinical Trials Essentials: An Intensive One-Week Course


Well-planned and well-executed clinical trials are the cornerstones of effective drug and medical device development. Offered in an accelerated format and taught by leaders in the biopharmaceutical industry, this course provides a unique opportunity for professionals from all disciplines to learn about the many facets of clinical trials--the complex process that ensures the safety and effectiveness of medical products.

Prerequisites:


No prerequisites


Medical Writing


All biopharmaceutical companies must produce scientific reports and summary documents for regulatory agencies. Good documentation should be not only scientifically sound, but also clear, effective and concise. This course provides the practical skills needed to write effective documents for the healthcare industry. You'll gain practice through hands-on exercises and group projects based on documentation used in pharmaceutical development.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X413.(3) 11/2/2018 06:00 PM SANTA CLARA 750 David A West View Enroll

Data Privacy and Security for Healthcare and Biosciences


Many companies in the healthcare and bioscience industries utilize Protected Health Information (PHI) or Personally Identifiable Information (PII) to develop and test products such as medical devices and mobile applications, or to perform other services, including data analysis, on their customer’s healthcare related data. This course examines the important data privacy and security issues that govern these industries.

Prerequisites:


No prerequisites


Preparing for FDA Inspections and Conducting Sponsor Audits


In the regulated pharmaceutical and biotech medical device industries, inspections by government agencies are often a prerequisite for new product-marketing approvals. Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. As the FDA and other regulatory authorities increase the frequency of inspections, it is imperative that everyone involved in the development of new therapies be familiar with government inspection processes and their role during these inspections.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Medical / Clinical Terminology


A basic understanding of medical and clinical terminology is essential in clinical trials design and management. This interactive workshop, for individuals with no background in medical/clinical terminology or for those who would like a refresher, reviews common terms associated with medical research and development and clinical trials. Participants review both the meaning of each term and how it is applied within a practical context.
This workshop is a prerequisite for the Clinical Trials Design and Management Certificate program.




(2928)

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X800.(3) 9/15/2018 09:00 AM SANTA CLARA 325 Maria Filippou-Frye View Enroll

Clinical Data Management


High-quality clinical data are at the heart of a successful clinical trial. If the data are not complete or do not reflect the actual reported results, the analysis and the conclusions drawn from that analysis may not be reliable. This course provides clinical trial personnel a solid understanding of the steps involved in clinical data management from study site data collection through data extraction for analysis.

Prerequisites:


No prerequisites


Clinical Statistics for Non-Statisticians


Clinical studies succeed or fail on the strength of their statistics. This course takes a practical approach to address the fundamental statistical concepts essential for non-statisticians involved in clinical research. Through lectures, discussions and in-class exercises, the instructor explores clinical study designs, hypothesis testing, sample size calculations, assumptions, controls, endpoints, data-management principles, data presentations and analysis plans, methods of analysis, and conclusions.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X403.(2) 7/9/2018 06:00 PM SANTA CLARA 750 Donald (Don) Y Young View Enroll

Clinical Trials Site Monitoring I


This course presents the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The course covers expectations of the FDA, the sponsor, and the site. The process of site selection, budgeting, initiation visits, source documentation, regulatory documentation, and adverse event reporting are additional topics covered.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X404.(3) 10/13/2018 09:00 AM SANTA CLARA 750 Savita O. Sinha View Enroll

Good Clinical Practices


Clinical research is governed by a set of broad regulatory requirements, industry standards and recommendations. Interpreting and implementing these “best practice” standards presents a challenge for all the stakeholders involved in human research. This course explores the framework and principles of Good Clinical Practice (GCP) as it relates to the roles and responsibilities of various stakeholders like the FDA, Investigator, Sponsor, IRB and the study subject.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X411.(3) 10/3/2018 06:00 PM SANTA CLARA 800 Narinder Singh View Enroll

Medical Devices: Regulatory Strategies and Marketing Pathways


Medical devices are different from drugs and biologics in their regulation and paths to market. Effective clinical trials design and management for devices requires a solid understanding of these issues. This course defines medical devices and explains routes to market, regulatory pathways, successful investigational device exemption (IDE) and PMA submissions to the FDA.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X412.(2) 7/10/2018 06:00 PM SANTA CLARA 675 Clarisa A Tate View Enroll

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