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OBSSR 战略计划 2025–2029
BSSR 对于促进健康和预防疾病尤其有价值，因为研究表明，美国的慢性病负担和全因死亡率可能主要归因于可预防的高危行为，例如缺乏身体活动、久坐不动、饮食不良以及吸烟和饮酒。0 上标 1. 参考脚注 1。上标 2. 参考脚注 2。此外，将 BSSR 纳入广泛的 NIH 研究事业有助于解决健康差距、促进健康公平，并确保干预措施具有文化敏感性并能满足不同人群的需求。BSSR 在产生可靠的科学知识并将这些知识转化为有益于所有人健康的实际应用方面发挥着关键作用。
数据和安全监控计划-Cedars -Sinai
Acronyms/Abbreviations Definition AD-CR Associate Director for Clinical Research AE Adverse Event BSSR Biostatistics Shared Resource CAPA Corrective and Preventative Action Plan CCTO Cancer Clinical Trials Office COI Conflict of Interest CRC Clinical Research Coordinator CRLC Clinical Research Leadership Committee CSCC Cedars-Sinai Cancer Center CSMC Cedars-Sinai Medical Center CTMS Clinical Trial Management System DHHS Department of Health and Human Services DLT Dose Limiting Toxicity DRG Disease Research Group DSMB Data Safety Monitoring Board DSMC Data and Safety Monitoring Committee DSMP Data and Safety Monitoring Plan FDA Food and Drug Administration IDE Investigational Device Exemption IND Investigational New Drug IIT Investigator-Initiated Trial IRB Institutional Review Board LOI Letter of Intent MTD Maximum Tolerated Dose NCI National Cancer Institute NCTN National Cancer Trials Network NIH National Institutes of Health ORCQI Office of Research Compliance & Quality Improvement PI Principal Investigator PRMC Protocol Review and Monitoring Committee PRMS Protocol Review and Monitoring System QA Quality Assurance QMC Quality Management Core RNI Reportable New Information SAE Serious Adverse Event SOP Standard Operating Procedures SPIN Sponsor-Initiated Support Unit SUSAR Suspected Unexpected Serious Adverse Reactions UPIRSO Unanticipated Problem Involving Risks to Subjects or Others