General help for the NIH clinical research studies

General Help

Explanation Of Clinical Studies Data Items

Protocol Number
The first two numbers specify the fiscal year the clinical study was initially approved. The letters represent the institute sponsoring the study. The last four numbers are assigned sequentially to each specific clinical study.

Name of the clinical research project representative of the studies primary focus.

Description of the study.

Sponsoring Institute
The table below lists institute abbreviations, acronyms, and full names.
AbbreviationAcronymInstitute Name
AANIAAANational Institute on Alcohol Abuse & Alcoholism
AGNIANational Institute on Aging
ARNIAMSNational Institute of Arthritis and Musculoskeletal and Skin Diseases
CNCINational Cancer Institute
CCCCNational Institutes of Health Clinical Center
CHNICHDNational Institute of Child Health and Human Development
DNIDRNational Institute of Dental and Craniofacial Research
DCNIDCDNational Institute on Deafness and Other Communication Disorders
DKNIDDKNational Institute of Diabetes and Digestive and Kidney Diseases
EINEINational Eye Institute
HNHLBINational Heart, Lung, and Blood Institute
HGNHGRINational Human Genome Research
INIAIDNational Institute of Allergy and Infectious Diseases
MNIMHNational Institute of Mental Health
NNINDSNational Institute of Neurological Disorders and Stroke
NRNINRNational Institute of Nursing Research

Recruitment Detail
Identifies both subject accrual type and the gender of the subjects participating in the clinical study. Subject accrual types include "Active Accrual of New Subjects" and "Follow-Up of Previously Enrolled Subjects Only."

Referral Letter Required
Identifies if participation in a protocol must be through a physician or if the protocols permits self-refer.

Population Exclusions
The subject population omitted from enrollment in a clinical research study for scientific reasons.

Eligibility Criteria
Identifies specific inclusion and exclusion criteria for subject enrollment in the clinical research study.

Special Instructions
dentifies information the Principal Investigator feels is pertinent for the patient to know when considering participating in the research study.

Disease Category
NIH clinical studies are grouped according to the International Classification of Diseases (ICD-9) disease categories.

Primary words, phrases, or acronyms, excluded from those found in the title that describe the study and are included in the search criteria to retrieve a protocol.

Recruitment Keywords
Primary words, phrases, or acronyms, identified by the Patient Recruitment and Public Liaison Office, used to identify protocols for possible patient participation.

Investigational Drug(s)
Identifies if the clinical research study involves an investigational drug.

Investigational Devices(s)
Identifies if the clinical research study involves an investigational device.

Principal Investigator
Information about the principal investigator includes the name and address of the person responsible for the coordination and conduct of the specific clinical study.

Source of reference for additional information pertaining to the clinical research study.

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