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CONTRACEPTIVE CLINICAL TRIALS NETWORK, CLINICAL EVALUATION OF LARC METHODS TO DETERMINE COMPARATIVE EFFECTIVENESS, ACCEPTABILITY, AND SAFETY.

CONTRACEPTIVE CLINICAL TRIALS NETWORK, CLINICAL EVALUATION OF LARC METHODS TO DETERMINE COMPARATIVE EFFECTIVENESS, ACCEPTABILITY, AND SAFETY.
避孕临床试验网络,对 LARC 方法进行临床评估以确定比较有效性、可接受性和安全性。
批准号:
10551058
负责人:
Dart Clint
金额:
$170.88万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
已结题
起止时间:
2018-07-23 至 2023-07-22
关键词:
AgeBenefits and RisksBiologicalCCL20 geneCase Report FormClinicalClinical ResearchClinical TrialsClinical Trials Data Monitoring CommitteesClinical Trials NetworkCollectionComputersConduct Clinical TrialsConfidentiality of Patient InformationContraceptive AgentsContraceptive methodsContractorContractsCounselingDataData AnalysesData CollectionData Management ResourcesDatabasesDevelopmentDevice ApprovalDevicesDrug ApprovalElectronic MailElementsEnrollmentEvaluable DiseaseEvaluationFood and Drug Administration Drug ApprovalFrequenciesGeographic LocationsGood Clinical PracticeGuidelinesIndividualInstitutional Review BoardsInternationalInvestigational New Drug ApplicationManufacturer NameMasksMeasurementMedicalMethodsMonitorMonitoring Clinical TrialsNational Institute of Child Health and Human DevelopmentNon obeseObesityParticipantPatientsPerformancePharmaceutical PreparationsPhasePreparationPrincipal InvestigatorProceduresProtocols documentationRandomizedReadabilityRegulationRelative RisksReportingResearch PersonnelSafetyScheduleSecureSerious Adverse EventServicesSiteSpecific qualifier valueStatistical Data InterpretationSystemTask PerformancesTelephoneTravelUnited States Food and Drug AdministrationUpdateVisitWomanWorkarmbaseclinical research sitecomparativecomparative effectivenesscontraceptive efficacydiariesfollow-upinnovationlaboratory facilitymedication safetymeetingsmembermulti-site trialnovel therapeuticspatient populationproduct developmentprotocol developmentquality assurancerecruitreproductiveresearch clinical testingsymposiumtechnical reportweb site

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中文摘要
翻译
提供统计和临床协调以及临床试验监测,包括与方案制定、数据收集、数据库准备、数据分析和编制选定女性避孕产品临床试验的临床研究报告相关的服务和支持。 本任务指令的目的是获得有效和可靠的数据,以确定用于肥胖和非肥胖育龄妇女的药物和器械的避孕有效性和安全性。除了临床评价和监测外,主要工作还包括数据库准备、数据分析、与获批方案相关的最终临床研究报告的准备,以及比较四项试验中评价的不同LARC方法的综合比较最终临床研究报告的准备。
英文摘要
To provide statistical and clinical coordination as well as monitoring of clinical trials, including services and support related to protocol development, data collection, database preparation, data analysis and preparation of clinical study reports of clinical trials of selected products for contraception in women. The objective of this Task Order is to obtain valid and reliable data to determine the contraceptive efficacy and safety of drugs and devices for use in obese and non-obese women of reproductive age. In addition to clinical evaluation and monitoring, the main work consists of database preparation, data analysis, preparation of the final Clinical Study Reports associated with the approved protocols, and preparation of a comprehensive Comparative Final Clinical Study Report comparing the different LARC methods evaluated in the four trials.
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CONTRACEPTIVE CLINICAL TRIALS NETWORK, CLINICAL EVALUATION OF LARC METHODS TO DETERMINE COMPARATIVE EFFECTIVENESS, ACCEPTABILITY, AND SAFETY.
  • 批准号:
    10788175
  • 项目类别:
  • 资助金额:
    $43.33万
  • 财政年份:
    2018
  • 负责人:
    Dart Clint
  • 依托单位:
CONTRACEPTIVE CLINICAL TRIALS NETWORK, CLINICAL EVALUATION OF LARC METHODS TO DETERMINE COMPARATIVE EFFECTIVENESS, ACCEPTABILITY, AND SAFETY.
  • 批准号:
    10412886
  • 项目类别:
  • 资助金额:
    $235.34万
  • 财政年份:
    2018
  • 负责人:
    Dart Clint
  • 依托单位:
海外基金