Microsoft Word search phase 3 Title Page Amendment

3.
 
Study Organization 
3.1.
 
PARTICIPANT ORGANIZATION 
3.1.1.
 
Study Centers 
Each clinical center consists of an interdisciplinary team of investigators who provide the 
areas of expertise necessary for the successful completion of the SEARCH protocol.  
Clinical center responsibilities include: 
a)
 
Collaborating in design and monitoring of the study, including regular attendance 
at Steering Committee meetings and participation in study-wide committees; 
b)
 
Identifying children and youth eligible for the study; 
c)
 
Recruiting and retaining study participants; 
d)
 
Collecting high quality data in a systematic and standardized fashion consistent 
with the study protocol; and,  
e)
 
Collaborating in the analysis and dissemination of study results. 
3.1.2.
 
Coordinating Center 
The Coordinating Center (CoC) has primary responsibility for monitoring quality and 
analyzing data generated in the study.  Additional responsibilities of the Coordinating 
Center include: 
a)
 
Preparing the protocol, forms, manuals, and educational and recruitment materials 
with the guidance and assistance of study investigators, Centers for Disease 
Control and Prevention (CDC), and National Institutes of Health (NIH) personnel; 
b)
 
Collaborating on development of the statistical design; 
c)
 
Working with the investigators in developing and pre-testing data collection 
forms and procedures, and assuming responsibility for the translation,  
reproduction and distribution of forms, hardware, and software associated with 
data entry; 
d)
 
Training data coordinators and other clinical center research support personnel; 
e)
 
Assuring data quality, study performance, and laboratory procedures; 
f)
 
Summarizing clinical center performance at regular intervals for the Study group; 
g)
 
Providing detailed reports regarding eligible participants, participant recruitment 
and data collection; 
h)
 
Providing support for committee meetings and conference calls; and,  

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Section 3 - Study Organization (Phase 3 - 12/2010) 
Section 3 - Page 2
 
i)
 
Preparing, in collaboration with the clinical investigators, various manuscripts of 
study results. 
3.1.3.
 
Central Laboratory 
The central laboratory has primary responsibility for training clinical center personnel on 
blood draw, processing and shipping procedures, monitoring quality of samples received, 
ensuring that samples are tested according to study protocol, and generating laboratory 
results for the study.  Additional responsibilities of the Central Laboratory include: 
a)
 
Developing and distributing a laboratory manual of procedures; 
b)