Frederic C. Bartter
General Clinical Research Center (GCRC)
Quality
Management (QM) and the
Data Safety and Monitoring Plan (DSMP)
From a quality management standpoint, the following discussion may be considered in developing, implementing, and monitoring Data and Safety Monitoring Plans (DSMPs). Quality Management includes the concepts of quality improvement, quality assurance and quality control.
Quality Improvement (QI) is considered a systemized approach to evaluating specific indicators. In regards to data and safety monitoring, one might consider the indicators of a) appropriate approvals from the IRB and GAC, and b) patient safety. Appropriate approval criteria will be a) documentation of approvals, and b) stipulation(s) addressed timely and appropriately. Patient safety criteria would include a) informed consent processes, and, b) risk(s) discussion.
Quality Assurance (QA) focuses on outcomes from a retrospective approach. In regards to data and safety monitoring, the P.I. would focus on the indicators of a) selection of research subjects b) adverse drug effects, and c) protocol compliance with IRB/GAC approved protocol. The selection of research subjects would include the criteria of the review of selection appropriateness in relation to fairness, social justice, and distributive justice.
Adverse effects criteria include, a) physiologic changes and/or toxicity results; and b) reporting elements. An adverse event may be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom or disease temporally associated with the use of a medical treatment or procedure regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following:• death,
• immediate risk of death
• inpatient hospitalization or prolongation of existing hospitalization
• a persistent or significant disability/incapacity, or
• a congenital anomaly/birth defect.
Compliance with IRB/GAC approved protocol includes the criteria of clinical periodicity assessment (other than lab) and administrative activities.
Quality Control (QC) targets process measures. In regards to data and safety monitoring, indicators should be a) laboratory and clinical measures, and b) documentation of patient review of systems & AEs.
Overview of the
requirements for a Data and Safety Monitoring Plan (DSMP)
Level of Risk Review Form (HTML)
(PDF)
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
RSA responsibility with
Quality Management (QM) and Data and Safety Monitoring (DSM)
Date page last modified: 08/08/05 03:05 PM
