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 Research: The Study Site Perspective


The conduct of clinical research requires effective working relationships between the study sites that execute clinical trials and the sponsors that design the trials and provide product for testing. This course offers practical insight into the clinical research process from the viewpoint of the study site. Lectures and class exercises explore the roles, responsibilities, interactions, and concerns of study site personnel and highlight important differences in perspective between clinical study sites and industry sponsors.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Clinical Trials Site Monitoring II


This course explores a range of approaches to monitoring clinical sites, the development of monitoring plans, and some of the more challenging aspects of monitoring clinical trials. Remote data entry, compliance audits, regulatory issues that arise in compliance audits, fraud and misconduct are also addressed. This course is designed for clinical research associates (CRAs) or those planning to become a CRA, clinical trial managers and clinical operations managers.


Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.




(2687)

Prerequisites:


Offering code Offering title
CTDM.X404 Clinical Trials Site Monitoring I

Contracting with Contract Research Organizations (CROs)


Pharmaceutical and biotechnology companies are more and more frequently using the services of contract research organizations (CROs) to access expertise or technology not available in-house for key clinical services in an effort to most effectively use limited resources. This course covers the identification, selection, and management of CROs in the performance of clinical projects.

Prerequisites:


No prerequisites


Document Preparation: Protocols, Reports, Summaries


Clinical trial documentation must be clear, scientifically sound, conform to regulations and established standard operating procedures, and follow regulatory guidelines. Despite pressure to start the trial "yesterday," a clinical trial cannot begin without a study protocol in place. Many other documents are needed before and during the trial, and the trial does not end until a final report has been submitted. Documentation of the trial often continues with articles in the biomedical literature.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X408.(1) 4/7/2018 08:30 AM SANTA CLARA 580 Romi Behbehanian View Enroll

Electronic Data Capture for Clinical Trials


A major trend among life science organizations has been the recent shift from manual, paper-based clinical data collection processes to the predominant use of electronic systems that expedite the availability of accurate clinical trial data. This course examines some of the key issues surrounding the industry's adoption of Electronic Data Capture (EDC) and gives students the opportunity to use EDC software on classroom computers during simulated clinical trials.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X410.(1) 2/23/2018 06:00 PM SANTA CLARA 580 Jeffrey H. E. Sonas View Enroll

Biology of Cancer


Understanding the molecular and cellular basis of cancer is essential for the development of new therapeutic strategies and diagnostic tools. This course explores the basic biology of cancer, including the key cellular processes and players, whose alteration leads to uncontrolled cell proliferation. Topics include the pathology and genetic basis of cancer, the immune system, and the role of infectious agents and environmental carcinogens in the disease process. You'll also discuss emerging therapies and strategies for cancer prevention.

Prerequisites:


Offering code Offering title
BTEC.X403 Cellular Biology

Viruses, Vaccines and Gene Therapy


The recent outbreaks of Zika and Ebola viruses and an increase in the rates of certain viral infections reflect the profound impact viruses have on human health worldwide. Students in the course study past viral pandemics—influenza, smallpox, and polio—and how they have altered human history. They survey how viruses replicate in human hosts and spread in human populations. Students also learn how recent developments in molecular biology and genetics have been instrumental to the biopharmaceutical industry in developing antiviral drugs and viral vaccines.

Prerequisites:


No prerequisites


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.(2) 2/3/2018 09:00 AM SANTA CLARA 325 Maria Filippou-Frye View Enroll

Regulation of Medical Devices and Diagnostics


What's the origin story of a medical device? Medical devices encompass a broad array of products, ranging from the tongue depressor to surgically implanted stents and pacemakers. This course provides individuals from all backgrounds with a solid grounding in the laws, regulations and institutions that underlie the process of medical device and diagnostic product development and marketing.


The instructor first defines medical devices, provides an overview of the medical device industry and the historical roots of medical device regulation.

Prerequisites:


Offering code Offering title
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X404.(1) 1/16/2018 06:00 PM SANTA CLARA 825 Clarisa A Tate View Enroll

Pages