The Clinical Trials Office - The Children's Hospital of Philadelphia ...

About UsThe Children'sHospital ofPhiladelphiaestablished the CTOin 1999 as part ofthe institution'semphasis on clinicalresearch. Sincethat time, the CTOhas experiencedrapid growth andnow offers a widearray of servicesto the Hospital andresearch community.The CTO advances the quality and quantityof clinical research at Children's Hospital andits associated network. Specifically, the CTOsupports research at the Hospital by developingand completing submissions to the Hospital'sIRB; assisting in the preparation of IND andIDE application submissions to the FDA;conducting clinical research studies underthe guidance of principal investigators; anddeveloping budgets and providing researchtraining for investigators, study coordinatorsand administrative staff.The CTO works in partnership withinvestigators to ensure the protection of humansubjects in accordance with GCP, federal, stateand/or local regulations and the requirementsof the study sponsor.CTO AdministrationLisa A. Speicher, Ph.D.Director, Clinical Trials OfficeNirmala Thevathasan, MPH, CCRCAssociate Director, Clinical Trials OfficeFor more information on the CTO or anyof our services, please visit our Web site athttp://stokes.chop.edu/programs/cto/index.phpor contact us at the address or phone number below.The Clinical Trials OfficeThe Children's Hospital of Philadelphia34th Street and Civic Center BoulevardPhiladelphia, PA 19104-4399267-426-0270The Clinical Trials OfficeExcellence in the Administration andManagement of Pediatric Clinical Studies

The Clinical Trials Office(CTO) at The Children’sHospital of Philadelphiais a centralized officethat provides resourcesand assistance to clinicalresearch investigators,enabling them to carryout clinical research in amanner consistent with theHospital’s goals — excellent patient care, top-qualityeducation, and innovative research. The CTO servesas the central focal point for clinical research activityat Children's Hospital and provides leadership,collegiality, and guidance to all study coordinatorsand other personnel. The CTO provides a variety ofservices that benefit both novice and experiencedclinical researchers. With expertise in implementing,conducting, and monitoring clinical trials, the CTOensures the excellence and compliance of clinicalresearch trials.The Value of DiversityThe CTO employsprofessionals withdiverse backgroundsand various levels ofeducation and experience.Our staff is composedof registered nurses,respiratory therapists,dieticians and other healthcare professionals. Staffmembers hold advanced degrees in a variety ofdisciplines including psychology, public health,business, education and clinical research. This broadrange of experience and knowledge provides a solidfoundation for a quality- and compliance-drivenclinical research program.Overview of ServicesnAssign experienced clinical research staff to workcollaboratively with principal investigators andstudy teams to initiate and facilitate qualityresearch and datam Study coordinators are available on a full-time,part-time or fee-for-service basism Clinical project managers and clinical researchassociates (monitors) are also availablenFacilitate study feasibility and study placementdecisionsnParticipate in the most current clinical research oncommon and rare pediatric diseases and conditionsnProvide expertise in all phases of drug trials, devicetrials, data collection studies and interview-basedstudiesnProvide operational and regulatory support forinvestigator-initiated and industry-sponsoredstudies that may require an Investigational NewDrug (IND) or Investigational Device Exemption(IDE) applicationnAssist with Institutional Review Board (IRB) andother regulatory submissionsnDevelop protocolsnServe as an initial liaison with pharmaceuticalcompaniesnTrain new and seasoned coordinatorsnEnsure trials are conducted following GoodClinical Practice (GCP) guidelines, Food and DrugAdministration (FDA) regulatory guidelines, andInternational Committee for Harmonization (ICH)guidelinesThe CTO frequently assists industry sponsorsand academic centers by identifying potential siteinvestigators at Children's Hospital. An investigatorwho would like to conduct a clinical trial or has beencontacted by an industry sponsor or academic centerto conduct a clinical trial should contact the CTOfor assistance.The CTO supports projects funded by a varietyof sources including, but not limited to, NationalInstitutes of Health, industry sponsors, foundations,organizations, and research networks.TrainingAll CTO clinical research coordinators and monitorsundergo an extensive clinical research orientationprogram. Training at the CTO includes:nHuman research subject protectionnGCP guidelinesnFDA and ICH guidelinesnEthics and the role of the IRBnInformed consent processnConfirmation of subject eligibilitynProtocol adherencenEnrollment goalsnResearch registration and billing compliancenAdverse event reportingnPreceptor and shadowing opportunitiesnMandatory continuingeducationIn order to maintain ahigh level of qualityfor our staff and theirresearch studies, the CTOencourages all eligiblecoordinators to sit forthe Clinical ResearchCoordinator Certificationexamination, administeredby the Associationof Clinical ResearchProfessionals (ACRP).ACRP is a nationallyrecognized organizationthat promotes effectiveclinical research.