The Environmental Polymorphisms Registry - Operational

环境多态性登记处 - 运行

• 批准号: 9171962
• 负责人: RICHARD COHN
• 金额: $ 6.75万
• 依托单位: SOCIAL AND SCIENTIFIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-10 至 2015-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9171962
• 关键词: Amendment; Blood; Blood specimen; Collection; Contractor; DNA; Data; Data Analyses; Data Collection; Databases; Development; Disease; Equipment; Genetic Polymorphism; Genotype; Health; Housing; Institutional Review Boards; Letters; Maintenance; Manuscripts; National Institute of Environmental Health Sciences; Newsletter; North Carolina; Participant; Phenotype; Preparation; Process; Progress Reports; Protocols documentation; Questionnaires; Recommendation; Recontacts; Recruitment Activity; Registries; Reporting; Research Personnel; Specimen; State Interests; Writing; base; cohort; data mining; design; follow-up; interest; protocol violation

The purpose of this SP is to continue activities for the Environmental Polymorphism Registry (EPR). The EPR has over 15,000 active participants recruited throughout North Carolina who have each donated blood for DNA isolation and genotyping. In addition, close to 9,000 participants have phenotypic data available through a health and exposure questionnaire. Originally the EPR SPs designed to be a “phenotype by genotype” cohort where once participants with genotypes of interest have been identified, investigators can apply for re-identification of the specimens and ask the same participants to participate in follow-up phenotyping studies. However, recently Investigators may also select participants to participate in follow-up studies based upon exposure or disease states of interest. Operational activities include recruiting subjects, recontacting and tracing all EPR subjects once a year, support development and maintenance of the EPR database, conducting data analyses and data mining to support EPR activities and the preparation of manuscripts, entering prior written data into the database, and supporting EPR genotyping and EPR phenotyping studies. Especially important is maintaining IRB compliance. Interacting with the IRB, obtaining IRB approval for protocols, and biospecimen collection. This includes developing and amending the study protocol and other associated documents (ICF, subject introduction letter, scripts, etc) that are required for IRB approval. Contractor may be required to revise study documents based on the recommendations of IRB, and aid with amendments, renewals, protocol violations and deviations and other IRB submissions.

该SP的目的是继续进行环境多态性注册表（EPR）的活动。 EPR在整个北卡罗来纳州招募了15,000多名活跃参与者，他们各自捐赠了血液以进行DNA隔离和基因分型。此外，近9,000名参与者可以通过健康和暴露调查表获得表型数据。最初，EPR SPS设计为“基因型的表型”队列，其中一旦确定了具有感兴趣基因型的参与者，研究人员可以申请重新识别该物种，并要求相同的参与者参与后续表型研究。但是，最近研究人员还可以选择参与者根据暴露或感兴趣的疾病状态参加后续研究。 操作活动包括每年招募主题，重新连接和追踪所有EPR主题，支持EPR数据库的开发和维护，进行数据分析和数据挖掘以支持EPR活动以及手稿的准备，并将先验的书面数据输入数据库，并支持EPR基因分类和EPR近似概况研究。与IRB相互作用，获得IRB批准的协议，并收集生物循环。这包括制定和修改IRB批准所需的研究协议和其他相关文档（ICF，主题介绍信，脚本等）。承包商可能需要根据IRB的建议进行修改研究文件，并协助修正，续签，违反规程和出发以及其他IRB提交的提交文件。