This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The DSMB is formally constituted with Dr. Robert Hunter as leader. The important input of Mrs. Miriam Vel zquez who functions as the quality control coordinator of the center and Mrs. Magaly Torres as the administrative assistant is acknowledged. During the year and as part of the regular meetings of the investigators updates on the relevant issues concerning the DSMB are given as well as a status report of the documents that are required to be filed with the DSMB office. The principal investigator of the center is kept informed on 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 reviewed as part of the yearly review include:1. Progress report of each project along with possible modifications made to the project. The number of subjects included, problems encountered, publications and abstracts2. IRB approval letter for the year and for modifications of the project3. Updated consent form including revisions required4. Letters of unexpected events with the required documentation 5. The name and CV of all investigators, and the name and credentials of research assistants. 6. 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.asp7. A confidentiality document 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 document is kept on file at the DSMB office. 8. A code of ethics was written and approved by the investigators of the CCHD. This was distributed in the winter of 2006Plans for 2007-2008 (DSMB)1. Conferences on the ethical conduct of research are being planned for early winter of this year. 2. Annual presentation of the data generated by the common instrument to all investigators3. Continue the monitoring process of reviewing and ensuring that the required documentation is present for all projects. E. Data Monitoring We have included the quality control officer as a member of the DSMB. She helps in the process of establishing the degree of accuracy of the reporting systems to the data core. This activity includes logical verification, accuracy of the questionnaires, degree of completeness of the instruments, and cross check the accuracy of the adverse events which may occurs. The data core has started to present summaries of the data submitted as it refers to the common instrument. This activity started on June of 2006 and includes presentation of a summary of data submitted per site and per project as it related to the common instrument. The data presents a summary of each variable in the instrument along with a summary of the variability per site of collection. Healthy group discussions regarding whether the observed variability is related to the process of data collection/submission vs. true population diversity is generated. It is planned that this exercise will be conducted every semester/year to keep the investigators in touch the global picture of the data submitted. It is anticipated that this effort will help in the decision process of instrument modification in the future ultimately resulting in an improved questionnaire. F. Safety MonitoringThe leader of the DSMB reviews all the documents outlined in the checklist for accuracy. He (she) reviews all new studies submitted to the center with the required documentation. A single site review for a random record review of subjects is planned for the year.
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