STI CTG Structure

The STI CTG has three major components: the Executive Committee (EC), the Scientific Review Committee (SRC), and the Operations Coordinating Center (OCC).  Bio statistics and data management support are provided by the University of Arkansas and Family Health International (FHI) respectively.

The Executive Committee (EC)

The EC sets the overall priorities for the STI CTG and develops the research agenda.

The Scientific Review Committee (SRC)

The SRC is composed of a broad range of exerts from the STI field who are part of the collaboration, as well as staff from the US Department of Health and Human Services (DHHS) and the Center for Disease control and Prevention (CDC).

The SRC role is to provide scientific guidance by reviewing and providing recommendations on research concepts and protocol proposals submitted to the EC.  SRC members work in partnership with or lend assistance to STI CTG collaborators during concept and protocol development.  Additionally, SRC members will participate on the Manuscript Review Committee.

The Operations Coordinating Center (OCC)

Family Health International

The OCC is responsible for the facilitation and management of the research operations of the STI CTG from review of concept sheets thru protocol development, review and approval to the publication of results.  The OCC is also responsible for the logistical and administrative support of the STI CTC EC and SRC.

FHI assigns a Protocol Specialist (PS) to each protocol as approved by the STI CTG EC.  The protocol specialist works with the Protocol Chair (PC) and a NIH Clinical Project Manager (CPM) to ensure that the draft protocol, and other pertinent study related documents, are developed and subsequently approved by the appropriate authorities.  The PS will remain as part of the study team thru closure.

Department of Biostatistics

University of Arkansas

The Department of Biostatistics at the University of Arkansas will serve as the Statistical Center for the Sexually Transmitted Infections Clinical Trials Group (STI CTG).  In this capacity, it will serve as a centralized resource for statistical needs of the group.  The Dept. of Biostatistics is available to provide assistance with statistical aspects of protocols and concepts prior to their submission to the EC/SRC and after approval for full protocol development and implementation.

Center for Data Management (CDM)

Family Health International

Data management support is provided by FHI’s Center for Data Management.  The CDM will provide assistance with data management for protocols to include design and finalization of data collection tools, design and validation of all data entry systems, reports to study teams as well as to the Data Safety Monitoring Board (DSMB).  FHI’s CDM has a web based query and report system which will allow study teams to respond to all data queries electronically as well as monitor study progress on-line.