The Environmental Polymorphisms Registry - Operational

这一战略文件的目的是继续开展环境多态登记处的活动。EPR在整个北卡罗来纳州招募了超过15,000名活跃的参与者，他们每个人都献血进行DNA分离和基因分型。此外，近9000名参与者通过健康和暴露问卷获得了表型数据。最初的EPR SPS被设计为“按基因表型”的队列，一旦确定了具有感兴趣的基因类型的参与者，研究人员就可以申请重新鉴定样本，并要求相同的参与者参与后续的表型研究。然而，最近，研究人员也可能根据暴露或感兴趣的疾病状态选择参与者参与后续研究。 业务活动包括招募受试者，每年重新联系和跟踪所有EPR受试者，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活动和手稿的准备，将以前的书面数据输入数据库，以及支持EPR基因分型和EPR表型研究。特别重要的是保持IRB的遵从性。与IRB互动，获得IRB对方案的批准，以及生物检疫采集。这包括制定和修改研究方案以及IRB批准所需的其他相关文件(ICF、主题介绍信、脚本等)。承包商可能被要求根据IRB的建议修改研究文件，并协助修改、更新、违反和偏离协议以及其他IRB提交的文件。

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.