This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DSMB The DSMB is formally constituted with Dr. Robert Hunter as its leader. There is also a quality-control officer who reviews possible irregularities in data management. In addition, there is an assistant who verifies that the submitted pertinent regulatory documents are in order. During the course of this year, and as part of the regular meetings of the investigators, updates on the relevant issues concerning the DSMB have been given as well as a status report detailing the documents that must be filed with the DSMB office. The principal investigator of the center is kept informed of all issues relevant to this committee. A checklist with the documents that the DSMB requires is distributed to all investigators several months before the end of the fiscal year with the purpose of having all necessary documentation on file towards the end of the research year. The documents that are evaluated in the yearly review include: 1. A progress report from each project, along with any modifications made to the project. Detailed here is the number of study subjects, problems encountered, and resulting publications and abstracts. 2. An IRB approval letter for the year (including any modifications of the project). 3. Updated consent forms, including required revisions, should there be any. 4. Letters of unexpected events with the required documentation 5. The names and CVs of all investigators and the names and credentials of research assistants. 6. A review of the certificate by the NIH course on Human investigations offered at the following web site: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp 7. A copy of the confidentiality agreement that has been created and given to each site. This document formalizes an agreement of data confidentiality by all individuals who directly or indirectly have access to the patient/client information. The signed original is kept on file at the DSMB office. 8. A copy of the code of ethics, which was written and approved by the investigators of the CCHD. This document was distributed in the winter of 2006. REPOSITORY Specific Aim. To provide PR-CCHD researchers with a core facility with easy access to store and retrieve frozen lymphocytes, plasma, and serum from HIV- and HCV-infected individuals. In addition, the services that this facility provides are now being utilized by researchers from other centers and programs Brief Project Description. Bar-coded frozen samples from individual investigators are stored in freezers with temperatures ranging from 0o to -1400C and monitored by inventory management software (Freezerworks F). This unit has improved the existing HIV-specimen repository with monitoring devices that keep inventory and quality control records. Special care has been taken to comply with HIPAA and IRB regulations. Researchers using human specimens are required to seek (and provide proof of) IRB approval. Miss Maridaliz Rodr?guez and Mrs. Myrna Vazquez are responsible for both the HIV Repository and the Laboratory Information System. Significance of the Study. The centralized repository provides investigators with an easy and reliable system to: a) repeat and confirm laboratory results;b) add additional tests in response to observed trends over time;c) design new projects and collaborations.
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