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.
