The Environmental Polymorphisms Registry - Operational

本SP的目的是继续开展环境多态性注册（EPR）的活动。EPR在北卡罗莱纳州招募了超过15,000名活跃参与者，他们每人捐献血液用于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EPR SPs被设计为“基因型表型”队列，一旦确定了感兴趣的基因型参与者，研究人员可以申请重新鉴定标本，并要求相同的参与者参加后续的表型研究。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加随访研究。

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.