Ensuring participant safety is of utmost importance in all Microbicide Trials Network (MTN) studies. Close cooperation between study investigators, site staff, US Division of Acquired Immunodeficiency Syndrome (DAIDS) Medical Officers and other NIH Medical Officers, DAIDS Safety Pharmacovigilance Team (SPT), Protocol Safety Physicians (CORE PSP) Clinical Research Managers (CORE [FHI] CRM), Statistical Data Management Center (SDMC) Project Managers (PMs), and other members of the study team is necessary to monitor participant safety closely and to respond to occurrences of potential harm in a timely manner.
The Three Tier Approach
The MTN uses a three-tiered approach to review safety data in order to identify potential safety concerns in a timely manner.
The first tier of clinical and laboratory data safety review involves study participants, study site clinicians, DAIDS Medical Officers, DAIDS RCC, DAIDS SPT, DIADS Regulatory Affairs Branch (RAB), and SDMC personnel.
Site clinicians are responsible for careful participant safety assessment and reporting of relevant clinical and laboratory data and for reporting AEs that meet the criteria for expedited reporting to the DAIDS RCC.
SDMC clinical affairs staff generates and reviews protocol-specific reports on a routine basis. SDMC clinical affairs staff also apply clinical data quality control notes (queries) to data requiring confirmation, clarification, or follow-up by site clinicians. These queries are sent to sites on a regular basis for resolution.
A Protocol Safety Review Team (PSRT) has been established for each MTN study involving an investigational agent or otherwise requiring AE reporting. This team includes at least one CORE PSP, the DAIDS Medical Officer, Protocol Chair, SDMC Protocol Statistician, SDMC clinical affairs staff, and others, depending on the protocol design and safety considerations.
For each study, the PSRT conducts routine reviews of safety data report. The PSRT will also convene to discuss any potential safety concerns. Depending on the nature of the study, the PSRT may have additional roles such as consultation and decision-making on AE reporting, toxicity management, and study product use management.
Phase IIb and III studies are reviewed by the US National Institute of Allergy and Infectious Diseases (NIAID) Prevention Trials Data and Safety Monitoring Board (DSMB). The DSMB examines the accumulated endpoint and safety data to make recommendations to DAIDS concerning continuation, termination, or other modifications of the study based on the observed beneficial or adverse effects attributable to the product being studied.
Protocol Safety Physicians
In support of PSRT functions, the CORE Protocol Safety Physicians review all safety data reports and prepare and distribute a summary of each report to the PSRT members. In addition, the Protocol Safety Physicians work closely with the
There are three Protocol Safety Physicians.
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