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  • Other Resources
    Programs Child Maltreatment Programs International Services Support Groups Services Search All Find a Doctor Patients Visitors Your Child s Hospital Stay Pay Your Bill Financial Assistance Medical Records Health Information Exchanges MyChart About Us Who We Are Newsroom Patient Stories Research Get Involved Events Publications Health Safety Health Library Ask Your Nurse Videos Safety Store at Rady Children s Rethink Your Drink Injury Prevention Growing Up Columns Locations Main Campus Satellite Locations Emergency Urgent Care Medical Professionals Office of Human Subjects Protection Other Resources Office of Human Subjects Protection Other Resources Medical Professionals CareLink Pediatric Grand Rounds Psychiatry Grand Rounds Research Conferences Professors Rounds Continuing Medical Education Graduate Medical Education GME Emergency Medicine Rotation Office of Human Subjects Protection Institutional Review Board Human Subjects Training Applications and Forms Meetings and Schedules Other Resources Help Education Development Peds Focus Rady Children s Physician Management Services Other Resources Need access to other resources Below are some links you may find useful Office for Human Research Protections Frequent Questions Belmont Report Decision Charts Guidelines on Expedited Review Procedures Tips on Informed Consent IRB Guidebook Office of Research Integrity FDA Forms FDA Information Sheets Center Watch Rady Children s Hospital San Diego 3020 Children

    Original URL path: http://www.rchsd.org/medical-professionals/office-of-human-subjects-protection/other-resources/ (2015-03-26)
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  • Help
    2008 Record Review Form if applicable and the Research Plan Details When do I have to turn in my review materials As soon as you have completed preparing your materials You will need to turn in three complete sets of information to the Office of Research Administration to start the review process There are IRB deadlines for submissions However if you wait until the IRB deadline to actually turn in your materials it is very unlikely that your study will be through the content and consent review in time to that specific meeting Do I have to come to the IRB meeting It is the policy of the Rady Children s IRB that the Principal Investigator does not have to be present at the IRB meeting unless there are substantive or controversial issues involved the IRB membership requests that the PI attend or the Principal Investigator chooses to attend the meeting Is there an IRB fee to have my study reviewed Yes there is a 1 500 fee for IRB review This is a one time fee that covers your study for three years If your study continues into a fourth year a 400 fee will be charged when you apply for your fourth year continuation approval What happens after the study is turned in After you have your IRB application ready you would submit the original plus nine sets to the Office for Human Subjects Protection Send an email to research rchsd org if you have any questions and or if you think your study may qualify for expedited review Details Where do I get information about the IRB policy and updates The IRB policy manual is current not available online The Office of Human Subjects Protection sends a notification via IRB Newsletter whenever there is any changes to the IRB policy and procedures The Newsletter is also posted online Renew or Close your Study How do I renew my study approval The Office of Human Subjects Protection sends out a letter of notification when a study approval period is nearing its end This letter will include a Study Status report form for you to complete and return along with a Study Summary report Please note that the letter of notification sent out by the Office of Human Subjects Protection is a courtesy reminder and should not substitute for the researcher s own internal tracking of expiration dates It is ultimately the investigator s responsibility to ensure that the continuing review request for the study is submitted to IRB on or before the study s expiration date Important information about the study renewal It is very important for investigators to plan ahead to meet required continuing review dates The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval Therefore continuing review and re approval of research must occur on or before the date when IRB approval expires To prevent lapse in continuing review a continuing review request must

    Original URL path: http://www.rchsd.org/medical-professionals/office-of-human-subjects-protection/help/ (2015-03-26)
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  • Course Descriptions
    Community Programs Child Maltreatment Programs International Services Support Groups Services Search All Find a Doctor Patients Visitors Your Child s Hospital Stay Pay Your Bill Financial Assistance Medical Records Health Information Exchanges MyChart About Us Who We Are Newsroom Patient Stories Research Get Involved Events Publications Health Safety Health Library Ask Your Nurse Videos Safety Store at Rady Children s Rethink Your Drink Injury Prevention Growing Up Columns Locations Main Campus Satellite Locations Emergency Urgent Care Medical Professionals Education Development Course Descriptions Education Development Course Descriptions Medical Professionals CareLink Pediatric Grand Rounds Psychiatry Grand Rounds Research Conferences Professors Rounds Continuing Medical Education Graduate Medical Education GME Emergency Medicine Rotation Office of Human Subjects Protection Education Development Course Descriptions Peds Focus Rady Children s Physician Management Services Course Descriptions Most courses offer CE contact hours through the Board of Registered Nursing or the Board of Behavioral Sciences Dates and times scheduled may change without notice Please contact Education and Development at 858 966 5941 or cjwalker rchsd org to confirm class dates Emergency Nurse Pediatric Course ENPC Neonatal Critical Care Course Neonatal Resuscitation Program NRP Neonatal Resuscitation Program Instructor Course PALS STABLE Rady Children s Hospital San Diego 3020 Children s

    Original URL path: http://www.rchsd.org/medical-professionals/education-development/course-descriptions/ (2015-03-26)
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  • February 2013
    Children s Rethink Your Drink Injury Prevention Growing Up Columns Locations Main Campus Satellite Locations Emergency Urgent Care Medical Professionals Peds Focus February 2013 Peds Focus February 2013 Medical Professionals CareLink Pediatric Grand Rounds Psychiatry Grand Rounds Research Conferences Professors Rounds Continuing Medical Education Graduate Medical Education GME Emergency Medicine Rotation Office of Human Subjects Protection Education Development Peds Focus February 2013 March 2012 November 2011 Rady Children s Physician

    Original URL path: http://www.rchsd.org/medical-professionals/peds-focus-newsletter/february-2013/ (2015-03-26)
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  • March 2012
    Giving P 858 576 1700 Programs Services Community Programs Child Maltreatment Programs International Services Support Groups Services Search All Find a Doctor Patients Visitors Your Child s Hospital Stay Pay Your Bill Financial Assistance Medical Records Health Information Exchanges MyChart About Us Who We Are Newsroom Patient Stories Research Get Involved Events Publications Health Safety Health Library Ask Your Nurse Videos Safety Store at Rady Children s Rethink Your Drink Injury Prevention Growing Up Columns Locations Main Campus Satellite Locations Emergency Urgent Care Medical Professionals Peds Focus March 2012 Peds Focus March 2012 Medical Professionals CareLink Pediatric Grand Rounds Psychiatry Grand Rounds Research Conferences Professors Rounds Continuing Medical Education Graduate Medical Education GME Emergency Medicine Rotation Office of Human Subjects Protection Education Development Peds Focus February 2013 March 2012 November 2011 Rady Children s Physician Management Services March 2012 The March 2012 issue of Peds Focus features cutting edge research in neurology oncology and pulmonary respiratory medicine Click here to view PDF Neurology featuring Joseph Gleeson M D Oncology featuring Donald Durden M D Ph D Pulmonary Respiratory Medicine featuring Gabriel G Haddad M D Rady Children s Hospital San Diego 3020 Children s Way San Diego CA 92123 Main

    Original URL path: http://www.rchsd.org/medical-professionals/peds-focus-newsletter/march-2012/ (2015-03-26)
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  • November 2011
    at Rady Children s Rethink Your Drink Injury Prevention Growing Up Columns Locations Main Campus Satellite Locations Emergency Urgent Care Medical Professionals Peds Focus November 2011 Peds Focus November 2011 Medical Professionals CareLink Pediatric Grand Rounds Psychiatry Grand Rounds Research Conferences Professors Rounds Continuing Medical Education Graduate Medical Education GME Emergency Medicine Rotation Office of Human Subjects Protection Education Development Peds Focus February 2013 March 2012 November 2011 Rady Children

    Original URL path: http://www.rchsd.org/medical-professionals/peds-focus-newsletter/november-2011/ (2015-03-26)
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  • FAQs
    have a condition or symptom or may be undergoing a procedure that may qualify him or her to participate in a study When your child is seen in the clinic or doctor s office or while your child is staying in the Hospital a doctor nurse or other staff member may ask you if you and your child would be interested in participating in a research study You will be given an explanation of what the study is about and what will be expected of you and your child Your child may need to take a medication and be available for examinations or special tests or you may need to fill out a questionnaire or keep a journal Why should my child participate in a clinical trial When your child participates in a clinical trial study the information obtained helps researchers understand about new treatments This understanding may lead to new or more effective treatments that could benefit others with the same condition This treatment may help your child or offer treatment choices that would not otherwise be available How do I decide It is important to ask questions Your doctor or study coordinator will give you detailed information about the study It may also help to talk to a family member your doctor or your child s pediatrician Your study doctor or coordinator will review a form called the informed consent with you This form contains important information about the study The consent explains why the study is being done what will happen during the study and the benefits and risks of participation What happens if my child or I don t want to be in the study If you or your child decides that you do not want to be in the study your child will still be

    Original URL path: http://www.rchsd.org/research/clinical-trials/faqs/ (2015-03-26)
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  • Center for Pediatric Clinical Research
    Clinical Research Upcoming Events Projects Office Financial Conflicts of Interest Office of Grants and Contracts UC San Diego School of Medicine Center for Pediatric Clinical Research Mission Statement The Mission of the Center for Pediatric Clinical Research is To provide children safe effective ethical and reliable evaluation of pharmaceuticals and devices in a caring environment To provide investigators with an efficient infrastructure committed research staff and operational expertise to recruit perform and manage clinical trials To provide sponsors with quality data in compliance with applicable federal regulations in a timely and cost effective manner To provide research team members an environment to grow and excel in their field through educational networking and training opportunities Program Assets Centralized clinical trials office and services Access to large diverse pediatric population and active database Rady Children s provides care to more than 155 000 children annually More than 222 000 outpatient and specialty clinic visits annually Patients are ethnic diverse and range in age from neonate to 18 years More than 700 children enrolled in clinical trials High enrollment and retention rate More than 35 pediatric subspecialties San Diego s largest pediatric specialty medical group Specializing in medical and surgical care of neonatal pediatric and adolescent and maternal fetal patient More than 90 pediatric specialty physician investigators Board certified or board eligible in their specialties Experienced clinical trial investigators in anesthesiology allergy immunology cardiology cardiovascular surgery craniofacial surgery dermatology gastroenterology genetics endocrinology hematology oncology infectious diseases intensive care neonatology nephrology neurology ophthalmology orthopedics otolaryngology pathology psychiatry rheumatology trauma and urology Multiple research settings Outpatient inpatient and community research settings including 28 satellite locations throughout the county Long standing proven partnerships Collaboration with University of California San Diego Member of Pediatric Pharmacology Research Unit network PPRU Member of Children s Oncology Group network COG

    Original URL path: http://www.rchsd.org/research/research-administration/center-for-pediatric-clinical-research/ (2015-03-26)
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