Throughout years one and two, Dr. Susan Scientist will be responsible for recruiting 120 study subjects from the State University Autism Center and collecting all Health-Related Quality of Life (HRQoL) data from this site. Dr. Scientist will also be responsible for monitoring the quality of the HRQoL data in accordance with the attached protocol and for reporting the data collected to Dr. Peter Physician of Massachusetts General Hospital following a schedule to be mutually determined by the end of year one.
Beginning in year three and continuing for the next six months, Dr. Scientist will create a parent focus group at the State University Autism Center and lead a series of meetings with this group. She will analyze the focus group data and, working with co-Investigators at MGH, will take the lead in drafting an enhanced autism-specific HRQoL tool. Dr. Scientist will be responsible for psychometric testing of this new tool at all collaborating sites and for analyzing and reporting these data to Dr. Physician by the middle of year four.
Throughout the course of the project, Dr. Scientist and her team will work with co-Investigators at MGH and all study sites to plan for and participate in the project’s Advisory Committee meetings, in addition to participating in monthly conference calls to discuss progress and providing written reports to Dr.
Physician on an annual basis for inclusion in the annual progress report and final report to the sponsor.
Dr. Scientist and her team will also work with Dr. Physician on the preparation of conference presentations and manuscripts reporting on the study.
The Kendall Square Scientific Institute is a recognized international leader in bringing the power of genomics to medicine, and, since it’s founding in 1990, has been a leader in developing automated methods for data production and analysis and managing these in a high throughput production environment.
Dr. Paul Physician will be the PI of the project at KSSI and will be responsible for performing a whole genome analysis scan (WSAS) using over 650,000 single nucleotide polymorphisms (SNPs) in 100 aviremic controllers, 1000 viremic controllers, and 500 age-gender-ethnicity matched control individuals with progressive viremicHIV-1 infection. Dr. Sarah Scientist will lead the sequencing component. She will be responsible for generating viral genomes from 1000 aviremic subjects, 250 progressors.
In year one, the KSSI will complete a WSAS of 300 controllers and 500 controls. This will be expanded in years two and three to 1000 aviremic and 1000 viremic controllers, as well as progressors. In years four and five, KSSI will perform extensive re-sequencing to identify the causal allele by re- sequencing the genomic region and dense genotyping of all known genetic variation in the region of interest across all samples. In years four and five, the KSSI will also perform replication experiments in 3000 ACTG samples to determine the degree of effective of genes initially identified on viral load. Re- sequencing will occur using the Sequenon genotyping platform.
Throughout the project Drs. Physician and Scientist will participate with the MGH co-Investigators in monthly conference calls and/or meetings to discuss progress and analyze data. In addition, on an annual basis they will provide the MGHPI with written progress reports for inclusion in the annual report and then final report to the sponsor.
Weak SOW Examples
Dr. Sam Scientist, at the University of Hawaii, has extensive experience with avian influenza infection at clinical bases in addition to his numerous researches on the avian influenza in basic studies. Dr. Scientist as a Program Director will be responsible for projects in Hawaii, in particular focusing on investigations using avian flu by comparing with human influenza viruses.
Dr. Patrick Physician, at the Beth Israel Deaconess Medical Center in Boston, has an extensive experience and knowledge in alveolar macrophage research, as he is a Director of Lung Macrophage Research Laboratory. He will be responsible for providing expertise about lectins on human alveolar macrophages and viral infection at the cellular level.
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