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Participating in Protocol Oversight and Steering Committee meetings and 
conference calls; 
c)
 
Providing supplies and support to clinical centers as needed; 
d)
 
Preparing monthly quality control reports for clinical centers; 
e)
 
Transmitting laboratory data to the CoC; and,  
f)
 
Participating as a scientific collaborator with SEARCH investigators. 
3.1.4.
 
Federal Sponsors 
SEARCH is sponsored by the CDC Division of Diabetes Translation (DDT) and 
supported by the National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) of the National Institutes of Health.  The SEARCH study centers are funded by 
a cooperative agreement, and the Coordinating Center is funded through a contract.  The 
CDC Project Office is responsible for the funding, cooperative agreement administration, 
monitoring, and overall scientific integrity of the study.  While the Principal Investigators 
will lead the scientific aspects of the study, representatives of the Federal agencies 
(CDC/NIDDK) will participate in all phases of planning, scientific design, 
implementation, evaluation and communicating results relating to SEARCH.   
The CDC reserves the right to prematurely terminate or curtail the study (or an individual 
award) in the event of human subject ethical issues that cannot be resolved.  
3.1.5.
 
External Scientific Evaluation Committee (ESEC) 
The External Scientific Evaluation Committee (ESEC) includes experts in the fields of 
diabetes, pediatrics, epidemiology, biostatistics, and health services research, augmented 
with ad hoc members as necessary, with appointments being made by the CDC in 
consultation with other sponsors.  Members are completely independent of the SEARCH 
study centers and affiliated investigators.  The ESEC reviews progress and conduct of the 
research.  ESEC will advise the sponsors of any concerns and/or make recommendations 
regarding continuation, termination, or modification of studies.  ESEC meets annually 
and hold additional meetings or conference calls as required for adequate monitoring. 

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Section 3 - Study Organization (Phase 3 - 12/2010) 
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3.1.6.
 
Data Ownership 
The data collected as part of SEARCH will belong to the respective clinical centers, and 
not the government or the Coordinating Center.  The Principal Investigator of each center 
will be the responsible custodian of the data.  All personally identifiable data will reside 
at the respective clinical centers and will not be transmitted to the Coordinating Center.  
Data collected by the University of Colorado Denver on Navajo Nation participants 
belong to the Navajo Nation, as stipulated in the Memorandum of Understanding.  As 
part of the SEARCH cooperative agreement and collaboration, each clinical center will 
share non- personally identifiable data with the coordinating center to create aggregate 
data sets, perform analysis, and prepare scientific presentations and communications.  
Additionally at the conclusion of the SEARCH study, a de-identified data set is required 
to be provided to the CDC and archived in a repository.   
3.2.
 
COMMITTEE STRUCTURE 
3.2.1.
 
Study-wide Committees 
The following study-wide committees are established for SEARCH: 
3.2.1.1.
 
Study Group 
The Study Group consists of everyone actively participating in the SEARCH study.  
Members of the Study Group who are not on the Steering Committee will participate 
in SEARCH through membership in standing committees, task groups, and writing 
groups and attendance at meetings when requested. 
The Study Group will meet monthly by conference call.  These calls will serve 
primarily to convey study status and as informational sessions.  Members of the Study 
Group who are not members of the Steering Committee will attend in-person 
meetings as needed to conduct the work of SEARCH. 
3.2.1.2.
 
Steering Committee 
The Steering Committee will accomplish the scientific work of SEARCH. The 
Steering Committee will consist of the PI and one other member from each clinical 
center, the chairs of main study-wide committees (see below), two members from the 
CDC, one member from the NIDDK, the Co-PIs from the CoC, and the PI from the 
Central Laboratory.  The Steering Committee will meet via conference call and as 
needed during face-to-face meetings. 
Clinical centers and the CoC will designate specific individuals as members of the 
Steering Committee.  Only these individuals will participate in calls.  Alternates can 
attend Steering Committee meetings when it is impossible for the designated 
members of this committee to attend. 

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Section 3 - Study Organization (Phase 3 - 12/2010) 
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All members of the Steering Committee are full participants in discussions and work 
of this committee.  In matters that require a vote, each study center will have one 
vote, including Clinical Centers, Coordinating Center, Central Laboratory, CDC and 
NIDDK. 
The Steering Committee makes final decisions on protocol changes, gives final 
approval prior to submission for all manuscripts, and directs the work of standing 
committees and Task Groups. 
3.2.1.3.
 
Executive Committee 
The Executive Committee will consist of the study co-chairs, the CDC and NIDDK 
Project Officer, the CoC Co-PIs, and one of the P&P co-chairs.  The chairs of the 
Ancillary Studies, Registry Oversight and Outcomes Committees will be asked to 
meet with the Executive Committee as needed.  The committee will meet via 
conference call to set the agendas for the calls and meetings, set priorities for use of 
call and meeting time, and to troubleshoot administrative problems as needed. 
3.2.1.4.
 
Protocol Oversight Committee  
The Protocol Oversight Committee (POC) will consist of representatives across the 
clinical centers, the CoC and the CDC.  The POC will have co-chairs and voting 
members.  Because of the nature of the committee’s charge, the chair of POC will be 
the Director of the CoC.  The committee will be responsible for reviewing aspects of 
the study protocol, including data quality control, adverse events, and recruitment and 
retention.  The POC will also make recommendations to the Steering Committee on 
modifications to the study MOP and Protocol.  The committee will report to the Study 
Group on a regular basis. 
3.2.1.5.
 
Publications and Presentations Committee 
The Publications and Presentations (P & P) Committee will consist of representatives 
from clinical centers, the CoC, the CDC and the Central Laboratory; representing a 
range of scientific expertise relevant to major aims of SEARCH.  The P & P 
committee will not necessarily include representatives from all centers.  The P & P 
committee will consist of SEARCH investigators with expertise in surveillance, 
epidemiologic methods, biostatistics, complications, risk factors for complications, 
health services research.  This P & P committee will have co-chairs and voting 
members; and one of the co-chairs will be a member of the Executive Committee.  
The committee will be responsible for reviewing and approving: abstracts; 
manuscripts; posters and oral presentations from SEARCH and its ancillary studies.  
The P & P committee is responsible for monitoring progress on manuscripts and 
presentations based on data from the main SEARCH study. 

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Section 3 - Study Organization (Phase 3 - 12/2010) 
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3.2.1.6.
 
Ancillary Studies Committee 
The Ancillary Studies Committee will consist of representatives from clinical centers, 
the CoC, the CDC and the Central Laboratory; representing a range of scientific 
expertise relevant to major aims of SEARCH.  This committee will have co-chairs 
and voting members.  The Ancillary Studies Committee will have the responsibility 
of approving ancillary study proposals from SEARCH and non-SEARCH 
investigators.   
3.2.1.7.
 
Registry Oversight Committee 
The Registry Oversight Committee (ROC) will consist of up to 10 members, not 
necessarily from each clinical center, with expertise and interest in epidemiologic and 
surveillance methods, study logistics, and biostatistics.  This committee will have co-
chairs, and voting members.  Nominations will be made to the study co-chairs and the 
executive committee will determine the final membership.  The ROC will provide 
oversight of issues concerning denominator estimation, including by race/ethnicity, 
completeness of case ascertainment, periodic case re-ascertainment, trends in 
incidence rates and prevalence, mortality surveillance and other areas as assigned by 
the executive committee. 
3.2.1.8.
 
Outcomes Committee 
The Outcomes Committee will consist of representatives from clinical centers, the 
CoC, the CDC and the Central Laboratory, representing a range of scientific expertise 
relevant to major aims of SEARCH.  The Outcomes Committee will focus on 
reviewing results of outcome measurements (retinopathy, neuropathy, arterial 
stiffness, nephropathy), developing and monitoring protocols, organizing feedback to 
participants.  The committee will have co-chairs and voting members, with particular 
emphasis on clinicians, project managers and investigators and staff with relevant 
expertise.  
3.2.1.9.
 
Recruitment and Retention Committee 
The Recruitment and Retention (R & R) Committee will consist of representatives 
from clinical centers and the CoC.  The R & R committee will have a chair who will 
serve one year terms.  The Recruitment and Retention Committee will be responsible 
for developing strategies for enhancing the recruitment and retention of SEARCH 
participants.  The committee will meet monthly via conference call, and will provide 
feedback to the Study Group on a regular basis. 
3.2.1.10.
 
Project Managers Committee 
The Project Managers Committee will consist of representatives across clinical 
centers and the CoC.  The Project Managers will have a chair and voting members.  

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Section 3 - Study Organization (Phase 3 - 12/2010) 
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The chair will serve one year terms.  The committee will be responsible for providing 
input to the Protocol Oversight Committee regarding clinic operations, recruitment 
and retention, and various aspects of protocol oversight.  The committee will report to 
the Study Group on a regular basis. 
3.2.2.