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Case Registration 
Cases that are valid, eligible and unique will be registered with the CoC.  Minimal 
information about the participant (age, gender, race/ethnicity, type of diabetes reported by 
clinician, date of birth and diagnosis and center) will be uploaded to the CoC website in 
order to protect confidentiality.  Names and addresses are not provided to the CoC.  
8.7.2.
 
Collection of Core Variables 
A minimum amount of demographic and clinical information will be collected for all 
registered cases in order for the study to be able to provide population-based rates of 
diabetes mellitus by age, gender, diabetes type and race/ethnicity for the entire population 
of cases.  This information is also critical in assessing possible response bias to the in 
person research visit.  This information is called “core” information. 

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8.7.3.
 
Medical Record Abstraction (MRA) 
The Medical Record Abstraction (MRA) serves the following purposes: a) validation of 
diabetes diagnosis; b) main source of core demographic and diagnostic information, and 
c) secondary data source for race/ethnicity information.  Additional set of items pertinent 
to clinical presentation will be collected:  weight/height at diagnosis, DKA at diagnosis, 
insulin use history.  
8.7.4.
 
Initial Participant Survey (IPS) 
The Initial Participant Survey (IPS) contains key data, including the core information 
described above, and serves the following purposes: a) verification of case eligibility 
(e.g., residence in the year of diagnosis); b) main source for self-reported race/ethnicity.  
Additional information includes: symptoms at presentation, potential secondary causes of 
the diabetes, use of insulin and other medications, treatment history, family structure, 
usual language spoken, and contact information (for local use only). 
8.7.5.
 
In-Person Research Visit (IPV) 
The IPV for of SEARCH 3 was designed to collect data on relevant dimensions of 
diabetes type (presence of autoimmunity, genetic susceptibility to autoimmunity, insulin 
sensitivity, insulin secretion) and data informing the clinical presentation of diabetes in 
youth.  Only cohorts incident in 2011 and 2013 will be eligible to participate in the IPV.  
To maximize the number of minority participants and youth with T2D, cases that will be 
eligible to participate in the SEARCH 3 IPV are 100% of minority youth, regardless of 
age and type, 100% of youth age ≥10 years at diagnosis, regardless of race/ethnicity and 
type, and 50% of NHW youth age < 10 years who have type 1 diabetes.  The content of 
the IPV will be similar to SEARCH 1 and 2 and will consist of collection of fasting blood 
and urine for laboratory measurements and storage and a physical examination.   
o
 
Measurements made to inform dimensions of diabetes type are DA (GAD65, IA-2 
with the proposed addition of the novel ZnT8 antibody, once assays are 
standardized);  
o
 
Validated insulin sensitivity  index (waist circumference, HbA
1c
, triglycerides);  
o
 
Urinary albumin and creatinine; 
o
 
Standard lipid measures; 
o
 
HLA risk genotypes and fasting C-peptide (FCP) (plasma glucose will be 
measured in order to interpret FCP); 
o
 
The IPV physical examination, conducted on children over the age of 3 years, will 
consist of height, weight, systolic and diastolic blood pressure, waist 
circumference and a standardized examination to determine the presence or 
absence of acanthosis nigricans.  Height will be measured in centimeters using a 

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stadiometer.  Weight will be measured in kilograms using an electronic scale.  
Blood pressure will be measured using the aneroid sphygmomanometer.  The 
NHANES and natural waist methods will used to measure waist circumference. 
8.8.
 
STUDY DATA 
Each newly diagnosed case will be assigned a unique SEARCH identification number and 
this SEARCH identification number will be used in order to link data across multiple visits.  
Each of the five SEARCH centers will maintain person’s names and contact information on a 
local basis, accessible only to the local research team.  The Protected Health Information 
(PHI) that is transmitted to the SEARCH Coordinating Center (CoC) for registered cases is 
the minimum necessary to conduct this research.  It consists of date of birth, county, zip 
code, date of diagnosis for diabetes, and dates of inpatient and outpatient visits.  Data 
transmitted to the CoC qualifies as a HIPAA Limited Dataset.  Each of the centers will enter 
into a Limited Data Use Agreement with the CoC in compliance with the Standards of 
Privacy of Individually Identifiable Health Information as outlined by the HIPAA privacy 
rules.  Local access to person’s identifiers will be governed by the requirements of the local 
IRB.  Laboratory specimens will be associated with the SEARCH identification number and 
the date of specimen collection.  Data transmitted to the laboratory qualifies as de-identified 
to the HIPAA standard.  Laboratory personnel are not able to identify individuals based on 
the information sent to them.  
8.9.
 
CONSENT FORMS 
The model consent and assent forms developed by the SEARCH study staff can be adapted 
to meet local IRB guidelines and criteria.  Consent of at least one parent or legal guardian 
will be required of all participants under the age of 18 years of age at the time of the survey 
or study visit.  Participants 18 years of age and older will sign as the participant and will not 
require additional signature of parent or legal guardian or when an emancipated minors. 
Consent forms will contain the following information: 
a)
 
Introductory information, explaining the objectives of the study 
b)
 
Procedures 
c)
 
Risks, Discomforts, Precautions 
d)
 
Incentives/compensation 
e)
 
Benefits 
f)
 
Alternatives of Care 
g)
 
Confidentiality of records 
h)
 
Optional consent to release test results to health care provider(s) 
i)
 
Availability of information 

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j)
 
Right to withdraw 
k)
 
Additional elements of consent 
l)
 
Any additional text required by the Center 
m)
 
Witnessing and signatures 
8.10.
 
ASSENT 
The age of assent and the method of obtaining assent will be defined and conducted in 
accordance with the guidelines of the local IRB. 
8.11.