Clinical Trials Ppt
CLINICALTRIALS DESIGN&MANAGEMENTPROGRAMPresented by:Karen Nelson Villanueva – Program LeadLajja Shah – CEL Assistant
DISCLAIMER You will be participating in an SF State event where audio and video is beingrecorded. By participating in this event, you consent to audio recording, videorecording and its/their release, publication, exhibition, or reproduction to beused for news, web casts, promotional purposes, telecasts, advertising on websites, or for any other purpose(s) that SF State, its vendors, partners, affiliatesand/or representatives deems fit to use. You release SF State, its officers andemployees, and each and all persons involved from any liability connectedwith the taking, recording, digitizing, or publication of interviews,photographs, computer images, video and/or or sound recordings. You have been fully informed of your consent, waiver of liability, and releasebefore participating in this SF State Event.
PROGRAM OVERVIEWEver-evolving governmentregulations are putting a newfocus on clinical trials in thepharmaceuticals, biologics, andbiotechnology deviceindustries.This program helps youbecome a successful memberin clinical research operations.Ideal fit for career changersand enhancersYou will gain a foundationalunderstanding of the field toimproving your overall duals who pursue thiscertificate are professionals,often with advanced degrees,working in science, health care,technology or management
LEARNING OUTCOMESThe Clinical Trials Design & ManagementProgram Certificate prepares students tobecome clinical research associates orcoordinators.Our curriculum covers core concepts, includingregulatory affairs, biostatistics, clinical trialsdesign, data management and safetymonitoring. The sequence of courses gives youskills that biotechnology and pharmaceuticalindustry employers are looking for.
WHY ENROLL WITH US?Taught by activeprofessionalsConvenientonline programYour own pace,up to 3 years 4,790 forcertificate
COURSE REQUIREMENTSRequires access to laptopand internet connectionFamiliarity with iLearnComfortable with onlinelearning environmentWebcam & micrecommended
CERTIFICATE REQUIREMENTSCourse #Required CourseIT 9357Overview of Clinical Development1.8IT 9358IT 9387IT 9388IT 9359IT 9386IT 9531Good Clinical Practices (GCP)Clinical Trials MonitoringClinical Trials DesignClinical Data ManagementBiostatisticsIntroduction to Regulatory Affairs (US)1.81.81.81.81.81.2IT 9539IT 9351IT 9354IT 9392Safety MonitoringClinical Project Management IClinical Project Management IICase Report Form DesignORCompliance Audits/FDA Inspections1.21.81.80.6IT 9391CEU0.6Once you have completed ALLthe necessary coursework,submit the Certificate ofCompletion Request Form:https://cel.sfsu.edu/certificaterequest
GET STARTEDü All students will need an SF State ID & Password to enable registration and Payment atCollege of Extended Learning. Use Quick Admit to obtain and SFSU ID and Passwordhttps://cel.sfsu.edu/register/quickadmitü Overview of Clinical Development and Good Clinical Practices are prerequisites to all otherclasses. Please contact us directly if you have any other questions.ü To access the online class, visit http://ilearn.sfsu.edu to log in after registration andpayment using SF State ID and password.
WAYS TO REGISTERIN PERSONREGISTRATIONComplete the Registration ments/register/regform.pdfDrop off the form at MainCampus or Downtown CampusONLINERegister & pay onlinewith gatewayinstructionsONLINE – STAFF ASSISTComplete the onlineregistration form, and you willbe contact within 24 HONECall (415-405-7700)Hours: Monday – Friday,9AM-5PM. Please haveyour SFSU ID and ClassNumbers ready
FACULTYRon LillieDirector – Drug Safety DataAnalytics @ Exelixis, Inc.Siu Po SitVP – Clinical Affairs @Penumbra Inc.Tenea NelsonToxicologist @ GenentechThomas TremblaySr. Director – Clinical Operations@ a local sf companyPeter ShabePresident @ AdvanceResearch Associates, Inc.Bethany Van VeenConsultant for Bay Areapharmaceutical companiesFabio De MartinoSr. Manager – Global Quality @GenentechWajiha AliSr. CRA @ AssemblyBiosciences, IncAbigail WaiteAssociate Director @BioMarin PharmaceuticalTo learn more about each faculty and theirbackground, please visit:https://cel.sfsu.edu/clinicalonline/faculty
THANKYOUKaren Nelson Villanueva,MPA, PhDProgram Leadpronouns: she, her, hersknv@sfsu.edu(415) 817-4324
IT9358 Good Clinical Practices (GCP) 1.8 IT9387 Clinical Trials Monitoring 1.8 IT9388 Clinical Trials Design 1.8 IT9359 Clinical Data Management 1.8 IT9386 Biostatistics 1.8 IT9531 Introduction to Regulatory Affairs (US) 1.2 IT9539 Safety Monitoring 1.2 IT9351 Clinical Project Management I 1.8 IT9354 Clinical Project Management II 1.8
Ebbinghaus’s Forgetting Curve For example, if Ebbinghaus took 12 trials to learn a list and 9 trials to relearn it several days later, his savings score for that elapsed time would be 25 percent (12 trials – 9 trials 3 trials; 3 trials 12 trials 0.25, or 25 percent). Using savings as his measure,
50 practice-changing clinical trials whose results were announced between 2014 and December 2020. The trials are presented under the CTEP-supported clinical trials program in which they were conducted. Studies Conducted by the National Clinical Trials Network (NCTN) o RxPonder (SWOG S1007)—The Rx for Positive Node, Endocrine Responsive Breast
Clinical Trials and CAM Introduction Clinical trials are an important part of medical research. They help scientists find better ways to prevent, detect, and treat diseases and medical conditions. This fact sheet provides an introduction to clinical trials in general and also to trials involving compl
6.1 . Clinical Trials Experience . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
Clinical Trials in the Piedmont Triad Clinical Trials for Top Chronic Diseases in the Piedmont Triad Chronic Disease All Clinical Trials Clinical Trials Still Recruiting Asthma 57 10 Cancer 359 53 Diabetes 220 22 Heart Disease 114 14 Mental Illness 112 7 Stroke 40 11 Total 902 117 Source: www.clinicaltrials.gov
CLINICAL TRIALS INTERVIEW QUESTIONS 1.Describe the phases of clinical trials? Ans:- These are the following four phases of the clinical trials: Phase 1: Test a new drug or treatment to a small group of people (20-80) to evaluate its safety.File Size: 1MBPage Count: 124
22.01.2015 Brussels, Belgium Clinical trials management Typical challenges Even among ‘regular’ FP7 projects: 50% of grants were not completed in time & had to be extended through an amendment Clinical trials are known to be particularly complex literature: up to 85% of clinical trials in general are not completed in time most common reasons for delays: site
Plan and monitor animal diet and nutrition LANAnC46 Plan and monitor animal diet and nutrition 1 Overview This standard covers planning and monitoring the diet and nutrition for animals in your care. You will need to identify the nutritional requirements of the animals and develop feeding plans containing all the necessary information for those responsible for feeding the animals. You will .
