WORKSHEET: Clinical Trial Registration



WORKSHEET: Clinical Trial RegistrationPurposeThis worksheet is intended to help researchers register their clinical trials by listing the specific data elements required for each module of the registration process at . This allows the person who will do the registration to see in advance what specific information will be required, before going into the PRS system. Tips for successful registration are provided at How to Register a Clinical Trial. See PRS Protocol Registration Data Element Definitions for the definition of each element.To StartLog into the PRS system at , using the UWashington organization, your user name and password. Select Create New Record. When you are doneUpdate the Record Verification Date in the Study Status module, to reflect the data you did the update. Click on COMPLETED at the top of the form. This sends an email notice to the Responsible Party (PI) that the record is ready for the Approval and Release actions. 1 – Study identificationUnique protocol IDUse the UW IRB number assigned to your study.Brief titleAcronym for studyOfficial titleSecondary IDsSecondary ID type Select one:NIH grant/contract award numberOther grant/funding numberRegistry identifier (from a clinical trial registry)EudraCT # from European Medicine Agency Clinical Trials DatabaseOther identifierDescriptionStudy type Select one:InterventionalObservationalObservational with Patient RegistryExpanded access2 – Study StatusRecord verification dateOverall recruitment status Select one:Not yet recruitingRecruiting (whether or not any have been enrolled)Enrolling by invitationActive, not recruitingCompetedSuspendedTerminatedWithdrawnWhy study stoppedStudy start datePrimary completion dateStudy completion date3 – Sponsors / collaboratorsResponsible Party, by official title Select one:Sponsor (entity that initiates the study) Principal InvestigatorSponsor-investigator (PI-initiated-and-conducted)For UW research: this is the Principal InvestigatorInvestigator InformationInvestigator nameInvestigator official titleInvestigator affiliationName of Sponsor OrganizationFor UW research: this is the University of WashingtonCollaborators4 – OversightStudies a FDA-regulated DeviceDevice not approved or cleared by FDA Select one:YesNoPost prior to FDA approval or clearance Select one:YesNoPediatric post-market surveillance of a device Select one:YesNoStudies a FDA-regulated drug Select one:YesNoInvestigational new drug (IND) / investigational device exemption (IDE) Select one:YesNoFDA Center Select one:CDER (drugs)CBER (biologics)CDRH (devices)IND/IDE numberIND serial numberAvailability of expanded access Select one:YesNoUnknownExpanded access record NCT numberProduct manufactured in and exported from the U.S. Select one:YesNoeHuman subjects protection review board (IRB) status Select one:Request for approval not yet submittedSubmitted and pendingSubmitted and approvedExemption grantedSubmitted and deniedSubmission not requiredBoard approval numberUse the IRB number assigned to your study. Board nameIf the UW IRB: University of Washington Institutional Review BoardBoard affiliationIf the UW IRB: University of WashingtonBoard contact: PhoneIf the UW IRB: 206.543.0098Board contact: Phone extensionIf the UW IRB: noneBoard contact: EmailIf the UW IRB: hsdinfo@uw.edu Board contact: AddressIf the UW IRB:Human Subjects DivisionBox 359470University of WashingtonSeattle, WA 98195-9470 USAData monitoring committee Select one:YesNoPlan to share IPD (individual participant data) Select one:YesNoUndecidedPlan descriptionFDA-regulated intervention Select one:YesNoSection 801 clinical trial Select one:YesNo5 – Study DescriptionBrief summaryDetailed description6 – Conditions and keywordsPrimary disease or condition being studied in the trial, or the focus of the studyKeywords7 – Study DesignInterventional study designPrimary purpose Select one:TreatmentPreventionDiagnosticSupportive careScreeningHealth services researchBasic scienceDevice feasibilityOtherStudy phase Select only one:N/A (e.g., device trials, behavioral intervention)Early Phase 1 (formerly called Phase 0)Phase 1Phase 1/Phase 2Phase 2Phase 2/Phase 3Phase 3Phase 4Intervention model Select one:Single groupParallelCross-overFactorialSequentialModel descriptionNumber of armsMasking Select all that apply:No maskingRoles, if maskingParticipantCare providerInvestigatorOutcomes assessorMasking descriptionsAllocation Select one:RandomizedNonrandomizedNot applicable (single arm trial)EnrollmentObservational study designObservational study model Select one:CohortCase-controlCase-onlyCase-crossoverEcologic or community studiesFamily-basedOtherTime perspective Select one:ProspectiveRetrospectiveCross-sectionalOtherBio-specimen retention Select one:None retainedSamples with DNA are retainedSamples without DNA are retainedBio-specimen descriptionEnrollmentTarget follow-up durationNumber of groups/cohorts8 – Arms, groups, and interventionsArm information, entered for each arm of an interventional studyArm titleArm type Select:ExperimentalActive comparatorPlacebo comparatorSham comparatorNo interventionOtherArm descriptionArm/intervention cross-referenceGroups/cohort information, entered for each group/cohortGroup/cohort labelGroup/cohort descriptionIntervention/exposure, entered for each intervention/exposure associated with an arm or groupIntervention type Select one:Drug (including any placebo)Device (including any sham)Biological/vaccineProcedure/surgeryRadiationBehavioralGenetic (including gene transfer, stem cell, recombinant DNA)Dietary supplementCombination productDiagnostic testOtherIntervention name(s)Other intervention name(s)Intervention description9 – Outcome measuresPrimary outcome measure informationTitleDescriptionTime FrameSecondary outcome measure informationTitleDescriptionTime FrameOther pre-specified outcome measuresTitleDescriptionTime frame10 - EligibilitySex/genderSex Select one:MaleFemaleAllGender Select one:Yes: eligibility is based on genderNo: eligibility is not based on genderGender eligibility descriptionAge limitsMinimum ageUnit of time Select one:YearMonthsWeeksDaysHoursMinutesN/A (No limit)Maximum ageUnit of time Select one:YearMonthsWeeksDaysHoursMinutesN/A (No limit)Other eligibility criteriaAccepts healthy volunteers Select one:YesNoEligibility criteriaStudy population descriptionSampling method Select one:Probability sampleNon-probability sample11 – Contacts, locations, and investigator informationCentral contact personFirst nameMiddle initialLast name or official titleDegreePhonePhone extensionEmailCentral contact backupFirst nameMiddle initialLast name or official titleDegreePhonePhone extensionEmailOverall study officialsFirst nameMiddle initialLast nameDegreeOrganizational affiliationOfficial’s role Select one:Study ChairStudy DirectorStudy Principal InvestigatorFacility information (for each participating facility)Facility nameCityState/provinceZIP/postal codeCountryIndividual site status (for each site) Select one for each site:Not yet recruitingRecruiting (whether or not any participants have been enrolled)Active, not recruitingCompletedSuspendedTerminatedWithdrawnFacility contact (for each participating facility)First nameMiddle initialLast name or official titleDegreePhonePhone extensionEmailFacility contact backupFirst nameMiddle initialLast nameDegreeRoleSelect one:Site Principal InvestigatorSite Sub-Investigator12 – ReferencesCitationsPubMed identifierCitationResults referenceLinksURLDescriptionAvailable study data/documents (provide this information for each)Type Select:Individual participant data setStudy protocolStatistical analysis planInformed consent formClinical study reportAnalytic codeOtherURLIdentifierCommentsResponsible Party Contact InformationName of individualOfficial titlePhysical addressName of organizational affiliationStreet addressCityState/provinceZIP/postal codeCountryMailing addressName of organizational affiliationStreet addressCityState/provinceZIP/postal codeCountryPhone and emailPhonePhone extensionEmail ................
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