This form structure is an organized set of data definitions for a form that has not been copyrighted

 General Details

Title:
Biomarker Assay Data Form
Short Name:
BiomarkerAssayDataForm
Description:
Standard form for protein and microRNA biomarker assay data.
Disease:
Traumatic Brain Injury , General (For all diseases)
Organization:
FITBIR
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Omics
Publication Date:
2016-10-26
Version:
1.1
Date Created:
2016-02-26
Owner:
Number of Data Elements:
75
eForms:
N

 Documentation


 Groups & Attached Data Elements

Logically grouped data elements with defined frequency at which they repeat.

# Title Short Description Variable Name Required? Type
1 GUID   Global Unique ID which uniquely identifies a subject GUID Required CDE
2 Subject identifier number   An identification number assigned to the participant/subject within a given protocol or a study. SubjectIDNum Optional CDE
3 Age in years   Value for participant's subject age recorded in years. AgeYrs Recommended CDE
4 Vital status   Status of participant/subject as alive or dead VitStatus Optional CDE
5 Visit date   Actual interview or visit date VisitDate Recommended CDE
6 Site name   The name of the site for the study SiteName Recommended CDE
7 Days since baseline   The number of days since baseline DaysSinceBaseline Optional CDE
8 Case control indicator   Indicator of whether subject is in the case or control arm of the study CaseContrlInd Optional CDE
9 General notes text   General notes GeneralNotesTxt Optional CDE

Additional Element Groups

Listed below are your additional element groups.

Form Administration (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Context type  The context to which the questions were answered ContextType Recommended CDE
2 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
3 Data source  Source of the data provided on the case report form DataSource Recommended CDE
4 Data source other text  The free-text field related to Data source specifying other text. Source of the data provided on the case report form DataSourceOTH Recommended CDE

Analyte and Test Result (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Analyte name  The molecule or molecular entity that is measured in an analytical procedure or assay. AnalyteNam Required UDE
2 HGNC gene symbol  Official gene symbol that has been approved by Human Genome Organization Nomenclature Committee (HGNC) HGNCGeneSymbl Recommended UDE
3 Analyte annotation identifier(s)  The list of analyte annotation IDs contains references to well-known public resources such as dbGaP, HGNC, NCBI, OMIM, UniProt, or other Proprietary Database. See Guidelines for more details AnalyteAnnotatnIDs Optional UDE
4 Lab test result score type  Indication of whether the reported lab test result value is raw or calculated value LabTestResultScoreTyp Recommended UDE
5 Lab test result value  Result of the laboratory test LabTestResltVal Recommended CDE
6 Lab test result unit of measure  Unit of measure for the laboratory test result LabTestResltUoM Recommended CDE
7 Limit of detection  The lowest quantity of a substance that can be distinguished from the absence of that substance (a blank value) within a stated confidence limit (generally 1%). LimitOfDetectn Optional UDE
8 Limit of detection unit of measure  Limit of detection unit of measure LimitDetectnUoM Optional UDE
9 Laboratory test lowest range value  Lowest possible value in the range of the lab test LabTestLowRangeVal Optional UDE
10 Laboratory test highest range value  Highest possible value in the range of the lab test LabTestHighRangeVal Optional UDE
11 Coefficient of variation(CV) in percentage  The standardized measure of dispersion of a probability distribution or frequency distribution, expressed as a percentage. CVinPercentage Optional UDE
12 Lab test result status  Status of the laboratory test result, usually based upon the comparison of the test result to the normal range for the lab test performed LabTestResltStatus Optional CDE
13 Test assay result abnormality subtype  The subtypes that provide further details on the abnormality condition for a given test assay result TestAssyResltAbnrmlySubtyp Optional UDE
14 Data file content type  Indicator as to whether or not the attached data file contains the raw data, processed data, both raw and processed data, or unknown DataFileContntTyp Recommended UDE
15 Molecular data file  Molecular data file MolDataFile Recommended UDE
16 Assay data - Platform quality control indicator  Indicator for the quality control for the platform that is used to carry out a molecular laboratory or computational experiment. PlatformQualContInd Recommended UDE
17 Assay data - Platform quality control text  Description of the quality control for the platform that is used to carry out a molecular laboratory or computational experiment. PlatformQualContTxt Recommended UDE
18 Assay data - Concentration type  Concentration type that is used to carry out a molecular laboratory or computational experiment. ConcentrationTyp Recommended UDE
19 Assay data - Concentration value  Concentration values that is used to carry out a molecular laboratory or computational experiment. ConcentrationVal Recommended UDE
20 Unit of measurement type  A unit of measurement is a definite magnitude of a quantity, defined and adopted by convention or by law, that is used as a standard for measurement of the same quantity. UnitOfMeasTyp Recommended UDE
21 Unit of measurement type other text  The text to describe a unit of measure that is not captured in the permissible values of the UnitOfMeasTyp data element. UnitOfMeasTypOthTxt Recommended UDE

Experiment Sample (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Organism NCBI Taxonomy Identifier  Organism NCBI Taxonomy Identifier OrganismNCBITaxonID Recommended UDE
2 Study sample name  Sample name assigned within a study where the sample is used. StudySmplNam Recommended UDE
3 Lab specimen type  Type of specimen collected for the laboratory test LabSpecmnTyp Recommended CDE
4 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Optional CDE
5 Biosample repository name  Biosample repository name BioSampReposNam Optional UDE
6 Biorepository sample name  Sample name assigned by the biorepository. BiorepositorySmplNam Optional UDE
7 Experiment sample name  Sample name assigned by the genotyping or sequencing service provider. ExprmntSmplNam Optional UDE
8 Quality control sample indicator  Indicator of whether the sample is used for quality-control in an experiment. CntrlSmplInd Recommended UDE
9 NCBI Biosample identifier  Biosample ID assigned by NCBI BioSample Database where the sample is registered with its metadata. NCBIBioSmplID Optional UDE
10 Sample identifier assigned by dbGaP  The sample identifier assigned by the database of Genotypes and Phenotypes (dbGaP) for the submitted subject sample. dbGaPSmplID Optional UDE
11 Molecule biological type  The type of molecule that was extracted from the biological material. Molecules can be DNA, RNA, and protein. MolBioTyp Optional UDE
12 DNA subtype  The subtype of a DNA molecule. DNASubTyp Optional UDE
13 RNA subtype  The subtype of an RNA molecule RNASubTyp Optional UDE

Assay and Reagent (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Optional CDE
2 Assay plate name  The assay plate name represents the plate or array name where standard curves, control samples, and experiment samples were collected and assayed. AssayPlatNam Recommended UDE
3 Assay kit name  Assay kit name AssyKitNam Optional UDE
4 Reagent name  The reagent name ReagntNam Optional UDE
5 Reagent description  The assay reagent description provides further details on the nature and purpose of the reagent. ReagntDesc Optional UDE
6 Reagent antibody registry identifier  Reference to AntibodyRegistry.org to describe antibody based reagents ReagntAnibodyRegistryID Optional UDE
7 Reagent manufacturer  Name of the reagent manufacturer. ReagentManuFacturer Optional UDE
8 Reagent lot number  Lot Number from the reagent manufacturer. ReagentLotNumTxt Optional UDE
9 Reagent catalog number  Identifier for the reagent in the vendor catalog. ReagentCatelogNumTxt Optional UDE

Experiment Metadata (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Molecular study laboratory name  Name of laboratory that performed the molecular study MolecularStdyLabName Recommended CDE
2 Experiment name  A user provided name for the experiment configuration ExprmntName Recommended UDE
3 Experiment purpose  The experiment purpose describes the nature of the data that will be collected. ExprmntPurpose Recommended UDE
4 Molecular platform vendor  The name of the company, facility or laboratory where the molecular platform was manufactured or produced. MolPltfmVndr Recommended UDE
5 Molecular platform vendor other text  Molecular platform vendor other text MolPltfmVndrOTH Optional UDE
6 Molecular platform name  The specific platform name or technology that is used to carry out a molecular laboratory or computational experiment. MolPltfmName Recommended UDE
7 Molecular platform version  The version of platform that is used to carry out a molecular laboratory or computational experiment. MolPltfmVer Optional UDE
8 Molecular platform distribution  The operational process by which a molecular platform is manufactured and made available. MolPltfmDist Recommended UDE
9 Assay classification category based on output type  Assay classification category based on output type OutputTypAssyClass Optional UDE
10 Experiment measurement technology type  Experiment measurement technology type ExprmntMeasmntTechTyp Recommended UDE
11 Experiment measurement technology type other text  Experiment measurement technology type other text ExprmntMeasmntTechTypOTH Optional UDE
12 Single- or multiplexing assay type  Indication of single- or multiplexing assay used in the experiment AssayPlexingTyp Optional UDE
13 Name of analysis software used on molecular data  Name of analysis software used on molecular data MolDataAnlysisSftwrNam Optional UDE
14 Dilution factor  The dilution factor is the ratio of aliquot volume to the final volume. It indicates how much a sample was diluted before it was assayed. DilutionFactor Optional UDE
15 Replication number  The number of times the experiment has been repeated for a biological sample. ReplicationNum Optional UDE
16 Laboratory protocol type  Types of laboratory protocols that are used in the design and implementation of experiments, also known as standard operations procedure(SOP). LabProtlTyp Required UDE
17 Laboratory protocol type other text  The free-text field related to 'Laboratory protocol type' specifying other text. It is a preferred list of terms to characterize the protocol's content. LabProtlTypOTH Optional UDE
18 Laboratory protocol file(s)  A single or collection of protocols that have been used in the design and implementation of experiments LabProtlFiles Required UDE
19 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

 Change History

 Administrative Change History