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)188.8.131.52.81.81.2IT 9539IT 9351IT 9354IT 9392Safety MonitoringClinical Project Management IClinical Project Management IICase Report Form DesignORCompliance Audits/FDA Inspections184.108.40.206.6IT 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, email@example.com(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
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
African Americans and Clinical Research If you have ever taken a pill or been treated for an illness, you have seen the benefit of clinical trials. Each year, thousands of African Americans take part in clinical trials to help find ways to prevent, treat, and cure illness. Clinical trials help African Americans and all people enjoy better health.
Conduct hands on review of clinical trials related claims and relate the review to the clinical trial billing rules . audit Review claims submitted on clinical trials that were denied and understand why 3 . “Clinical Trials Policy
UNIVERSITY MEDICINE B E R L I N KKS* / ZKS** - History 1990ies and ICH GCP: Increasing complexity for clinical trials and decreasing numbers of non-commercial clinical trails Insufficient quality of clinical trials results (data and timelines) Insufficient knowledge of methods for clinical trials in the academic community With
The Salem Witch Trials N. Carr G. Elliott B. Forletta D. Mark 11th December 2016 Abstract The Salem Witch Trials were a series of trials and executions which took place in the Puritan town of Salem, Massachusetts between 1692 and 1693. These trials were based on accusations of witch-craft, a
tissue stem cells. According to ClinicalTrials.gov, more than 680 clinical trials using MSCs are registered for cell therapy of many fields including liver diseases (more than 40 trials) and inflammatory bowel diseases (more than 20 trials).
Show PPT 1-1 as you refer participants to Page 1 in Module 1 of their Participant Guides. Introduce the module by saying that before they learn the specifics of electrical safety, you want to make sure everyone has a common understanding of electrical basics. This module will cover the basics. PPT 1-2 through PPT 1-4 Show PPT 1-2 through PPT 1 .
and PFOS concentration of 8.1 ppt, ranging from 5.3 to 12.2 ppt. Results from the Schuylkill River water treatment plant intakes exhibited an average combined PFOA and PFOS concentration of 12.1 ppt and 9.7 ppt, respectively, ranging from 6.8 to 16.2 ppt.
Supply Chain Risk Management Council established to oversee the program . PPT, PPT template, toolkit, PPT toolkit, corporate template, corporate PPT template, PowerPoint template, Juniper PPT template Created Date: 12/13/2017 9:32:19 AM .File Size: 874KBPage Count: 22
Guidelines for Phase I clinical trials 2018 edition 1 Developing a new medicine 7 1.1 First-in-Human trial (Phase I exploratory trial) 9 1.2 Subsequent parts/studies (clinical pharmacology trials) 9 2 Regulations 10 3 MHRA 12 3.1 Clinical Trial Authorisation (CTA) app
Reviewing Clinical Trials: A Guide for the Ethics Committee Editors Johan PE Karlberg and Marjorie A Speers Clinical Trials Centre, The University of Hong Kong Hong Kong SAR, PR China . Clinical Equipoise_ 32 Superiority, Non-inferiority and
Clinical Trials Accurate patient recruitment forecasts are critical to the clinical trial planning process. Here, our recommendations on ways to remain on target and avoid huge losses in terms of time, effort and investment. Executive Summary. Clinical trials are typically the most crucial part of a
with API 650’s level of risk of tank failure. Likewise, the rules in the external pressure appendix will be consistent with the basic part of API 650 with regard to loading conditions and combinations. Thus, starting with a specified design external pressure, roof live or snow load, and wind pressure (or velocity), the total roof design pressure is calculated as the greater of DL (Lr or S .