Frederic C. Bartter
General Clinical Research Center (GCRC)
RSA
responsibility with Quality Management (QM) and
Data and Safety Monitoring (DSM)
The Research Subject Advocate (RSA) of the GCRC will be responsible for managing and implementing the quality management program for research subject data and safety monitoring. The Research Subject Advocate (RSA) will also monitor, through audits, that the P.I. submits adverse event reports completely and in an expeditious manner to the IRB and appropriate federal agencies. The RSA will help coordinate with the IRB and GAC that the approved monitoring plan is fully implemented. Also, that the protocol carried out at the GCRC complies with the IRB and GAC approved protocol. Random audits of the study population will be completed on pertinent study documents (GCRC protocol file, clinical records, clinical flow sheets, etc.). Because of the nature of quality review specific to human subject involvement, all criteria must be met 100% of the time. If there are any deviations from 100%, exceptions to meeting the criteria may be specified, which might substantiate any unmet criteria. Summary reports of the audits will be presented to the GAC and P.I.
The intent of the data and safety monitoring is to 1) assure compliance with federal mandates, and, 2) ensure subject safety and minimize risks. QM emphasizes system improvement by identifying root causes contributing to system deficiencies, rather than punitive action without recommended system changes. The RSA will follow the Quality Management steps as outlined by Juran (http://www.juran.com) in assessing system, process, and structural patterns that may warrant policy, procedure, or systematic changes.
Specifically, the steps are:
collecting the data,
developing composite information for analysis,
identification of patterns and common variations,
recognizing possible causes for the variations,
focusing on the root causes,
validating the sources of the root causes,
identifying remedial action,
setting priorities for changes,
developing a plan for change (to include time frames),
implementing change(s), evaluating the effect of the change(s), and
reengineering if necessary.
The focus of quality management is to continuously change systems and processes for the purpose of enhancing and improving research activities, health care service delivery, subject satisfaction, and assuring subject safety.
The GCRC RSA will primarily be responsible for:
meeting, upon request, with the P.I. for DSMP assistance prior to IRB submission;
conducting chart audits for DSMP compliance;
reporting to the P.I. chart audit findings, with recommendations;
monitoring the submission of AEs to the IRB and GCRC for consistency with documentation; and
reviewing the AEs and analyze for trends, and reporting summary reports to the GAC.
Overview of the
requirements for a Data and Safety Monitoring Plan (DSMP)
Level of Risk Review Form (HTML)
(PDF)
Quality Management (QM) and the Data and Safety Monitoring
Plan (DSMP)
Data and Safety Monitoring Plan Guidelines
Data and Safety Monitoring Plan document
PDF Word
VA Policies related to the GCRC DSMP
Joint Commission 2004 Hospital Accreditation
Standards Applicable to the GCRC DSMP
Date page last modified: 08/08/05 03:04 PM
