Human monitoring data data formats

Human (bio)monitoring data are analytical measurements of chemical substances or markers of health effects in body fluids or tissues. This data can be used for assessing (combined) exposure to chemicals and the risks associated with this exposure. MCRA supports upload of this data in two formats: a relational table structure that matches the internal representation of MCRA and the PARC harmonized HBM data format.

Relational human monitoring concentration data format

The relational human monitoring concentrations data format is the format that is used internally in MCRA. The data format consists of a number of tables for specification of the study, the individuals of the study (and their specific characteristics), and the human (bio)monitoring samples and sample analyses.

Download empty dataset template: Zipped CSV Excel

Human monitoring surveys

Contains the definitions of the human (bio)monitoring surveys/studies.

Accepted table names: HumanMonitoringSurveys, HumanMonitoringSurvey.

Table 129 Table definition for Human monitoring surveys.
Name Type Description Aliases Required

idSurvey

AlphaNumeric (50)

Unique identification code of the survey.

idSurvey, idStudy

Yes

Name

AlphaNumeric (100)

Name of the study/survey.

Name

No

Description

AlphaNumeric (200)

Description of the study/survey.

Description

No

Location

AlphaNumeric (50)

The location or country where survey is held. It is recommended to use ISO Alpha-2 country codes.

Location, Country

No

BodyWeightUnit

AlphaNumeric (50)

The unit of bodyweight of the individuals of the survey: kg (default) or g.

BodyWeightUnit, UnitBodyWeight, WeightIn

No

AgeUnit

AlphaNumeric (50)

The unit of age, i.e., year or month.

UnitAge, agein, AgeUnit

No

StartDate

DateTime

The starting date of the survey.

StartDate

No

EndDate

DateTime

The end date of the survey.

EndDate

No

NumberOfSurveyDays

Integer

The number of days each individual participated in the survey.

NumberOfSurveyDays, NDaysInSurvey

Yes

idPopulation

AlphaNumeric (50)

Unique identification code of the population.

IdPopulation, PopulationId

No

LipidConcentrationUnit

ConcentrationUnit

The unit of the lipid concentration (defaults mg/dL).

LipidConcentrationUnit, LipidUnit

No

TriglycConcentrationUnit

ConcentrationUnit

The unit of the triglycerides concentration (defaults mg/dL).

TriglycConcentrationUnit, TriglyceridesConcentrationUnit, TriglyceridesUnit

No

CholestConcentrationUnit

ConcentrationUnit

The unit of the cholesterol concentration (defaults mg/dL).

CholestConcentrationUnit, CholesterolConcentrationUnit, CholesterolUnit

No

CreatConcentrationUnit

ConcentrationUnit

The unit of the creatinine concentration (defaults mg/dL).

CreatConcentrationUnit, CreatinineConcentrationUnit, CreatinineUnit

No

Individuals

The individuals of a survey are recorded in the Individuals table. Add additional properties like Region, Breastfeeding to further describe an individual. In table IndividualProperties, each property in the Individuals table is described (recommended way). Note that only those properties that are available in the Individuals table are used in module Populations, table Populations or PopulationIndividualPropertyValues to subset the individuals. This is only relevant when the UseData option in the population module is used.

Accepted table names: Individuals, SurveyIndividuals, ConsumptionSurveyIndividuals, FoodConsumptionSurveyIndividuals.

Table 130 Table definition for Individuals.
Name Type Description Aliases Required

idIndividual

AlphaNumeric (50)

Unique identification code of the individual.

idIndividual, IndividualId, Individual, Id

Yes

idFoodSurvey

AlphaNumeric (50)

The identification code / short name of survey.

idSurvey, idFoodSurvey, Survey, FoodSurvey, SurveyId, FoodSurveyId, SurveyCode

Yes

BodyWeight

Numeric

The body weight of the individual.

BodyWeight, Weight

Yes

SamplingWeight

Numeric

The sampling weight for an individual (default = 1).

SamplingWeight

No

NumberOfSurveyDays

Integer

The number of days the individual participated in the survey.

NumberOfSurveyDays, NumberOfDaysInSurvey, DaysInSurvey, NDaysInSurvey

No

Name

AlphaNumeric (100)

Name or label of the individual.

Name

No

Description

AlphaNumeric (200)

Additional description of the individual.

Description

No

Individual properties

Other individual properties can be added like the fields Age, Gender, Region etc. These properties are automatically parsed as co-factors or co-variables.

No

Individual properties

This table is used to describe the properties used in the Populations or PopulationIndividualPropertyValues table characterising the population (table Populations) and/or the properties used in the Individuals table characterising an individual. Properties like Age, Gender, Region are describing an individual (PropertyLevel = Individual). Properties like Period (for populations) or Month (sampling date for an individual day) are describing an individual day (PropertyLevel = IndividualDay).

Accepted table names: IndividualProperties, IndividualProperty.

Table 131 Table definition for Individual properties.
Name Type Description Aliases Required

idIndividualProperty

AlphaNumeric (50)

The code of the property.

idIndividualProperty, IndividualPropertyId, IndividualProperty

Yes

Name

AlphaNumeric (100)

The name of the property.

Name

No

PropertyLevel

PropertyLevelType

The level of the property. This type follows a controlled terminology, with possible values: Individual or IndividualDay.

PropertyLevel, LevelProperty

No

Description

AlphaNumeric (200)

Description of the property.

Description

No

Type

IndividualPropertyType

This field specifies the type of the values of this individual property. This type follows a controlled terminology, with possible values: Boolean, Categorical (default), Numeric, Nonnegative, Integer, NonnegativeInteger, Month, Datetime, Gender.

Type

No

Individual property values

Not recommended. This table describes individual property values. Property values are describing an individual for properties like e.g. Region, Breastfeeding. The recommended way is to add these columns as additional columns in the Individuals table. In table IndividualProperties, each property in the IndividualPropertyValues table is described.

Accepted table names: IndividualPropertyValues, IndividualPropertyValue.

Table 132 Table definition for Individual property values.
Name Type Description Aliases Required

idIndividual

AlphaNumeric (50)

The identification number of the Individual.

Id

Yes

PropertyName

AlphaNumeric (50)

The name of the property.

Name

Yes

TextValue

AlphaNumeric (50)

The value of the property as text value.

No

DoubleValue

Numeric

The value of the property as number.

No

Analytical methods

The analytical methods used for analysing the samples are recorded in the analytical methods table. Each analytical method should have a unique identification code (idAnalyticalMethod). The description field may be used for a more detailed description of the analytical method. The records of this table should be linked to one or more analytical method substance properties table, which record the substances that are measured by this method (and their limits of reporting).

Accepted table names: AnalyticalMethod, AnalyticalMethods.

Table 133 Table definition for Analytical methods.
Name Type Description Aliases Required

idAnalyticalMethod

AlphaNumeric (50)

The code for the method of analysis.

idAnalyticalMethod, AnalyticalMethodId, AnalyticalMethodName, Id

Yes

Name

AlphaNumeric (100)

Name of the analytical method.

Name

No

Description

AlphaNumeric (255)

Additional description of method of analysis.

Description

No

Analytical method properties for substances

This table describes the substances analysed by an analytical method. For each substance analysed by an analytical method a record should be included that describes the unit of measurement and the reporting limits (LOQ/LOD).

Accepted table names: AnalyticalMethodSubstances, AnalyticalMethodSubstance, AnalyticalMethodCompounds, AnalyticalMethodCompound.

Table 134 Table definition for Analytical method properties for substances.
Name Type Description Aliases Required

idAnalyticalMethod

AlphaNumeric (50)

The code of method of analysis.

idAnalyticalMethod, AnalyticalMethodName, AnalyticalMethodId

Yes

idSubstance

AlphaNumeric (50)

The substance code.

idSubstance, SubstanceId, Substance

Yes

LOD

Numeric

The limit of detection (LOD) is the lowest concentration of an substance in a sample that can be consistently detected.

LOD

No

LOQ

Numeric

The limit of quantification (LOQ) is the lowest concentration of a substance that can be quantified. The LOQ should be larger than the LOD.

LOQ, LOR

No

ConcentrationUnit

ConcentrationUnit

The unit used for reporting the LOD, LOQ, and the substance concentrations. When not specified, then a default unit of mg/kg is assumed.

ConcentrationUnit, Units, Unit

No

Human monitoring samples

Describes the samples taken during the study. Each sample has a unique identifier/code.

Accepted table names: HumanMonitoringSamples, HumanMonitoringSample.

Table 135 Table definition for Human monitoring samples.
Name Type Description Aliases Required

idSample

AlphaNumeric (50)

Unique identification code of the monitoring sample.

idSample, Sample

Yes

idIndividual

AlphaNumeric (50)

Unique identification code of the individual.

idIndividual, IndividualId, Individual, Id

Yes

DateSampling

DateTime

Date of sampling.

DateSampling, DateOfSampling, SamplingDate

No

DayOfSurvey

AlphaNumeric (50)

Identification code of the day of measurement.

Day, idDay, DayId, DayOfSurvey

Yes

TimeOfSampling

AlphaNumeric (50)

Identification code of the time of sampling.

TimeOfSampling, SamplingTime, TimeSampling

No

SampleType

AlphaNumeric (50)

Type of sample (e.g., pooled, 24h urine, spot urine, serum from blood, etc.).

SampleType, SamplingType

No

Compartment

AlphaNumeric (50)

If applicable, the measured compartment of the human body (e.g., blood, urine). When specified, the measurements are considered at the level of internal doses.

Compartment

No

ExposureRoute

AlphaNumeric (50)

If applicable, the measured exposure route, e.g., dermal (in case of skin wipes). When specified, the measurements are considered at the level of external doses.

ExposureRoute

No

SpecificGravity

Numeric

Specific gravity of the measured person for this particular sample.

SpecificGrafity, SpecificGravity

No

SpecificGravityCorrectionFactor

Numeric

Correction factor for the concentration to account for the specific gravity of the measured person for this particular sample.

SpecificGravityCorrectionFactor

No

Name

AlphaNumeric (100)

Name of the human monitoring sample.

Name

No

Description

AlphaNumeric (200)

Additional description of the human monitoring sample.

Description

No

LipidGrav

Numeric

Lipid content based on gravimatic analysis of the measured person for this particular sample.

LipidGrav, LipidGravimatic

No

LipidEnz

Numeric

Lipid content based on enzymatric summation of the measured person for this particular sample.

LipidEnz, LipidEnzymatic

No

Triglycerides

Numeric

Triglycerides total of the measured person for this particular sample.

Triglyc, Triglycerides

No

Cholesterol

Numeric

Cholesterol total of the measured person for this particular sample.

Cholest, Cholesterol

No

Creatinine

Numeric

Creatinine content of the measured person for this particular sample.

Creat, Creatinine

No

Human monitoring sample analyses

Contains the measurements of the samples of human monitoring studies.

Accepted table names: HumanMonitoringSampleAnalyses, HumanMonitoringSampleAnalysis.

Table 136 Table definition for Human monitoring sample analyses.
Name Type Description Aliases Required

idSampleAnalysis

AlphaNumeric (50)

Unique identification code of the sample analysis.

idSampleAnalysis, SampleAnalysis

Yes

idSample

AlphaNumeric (50)

Code of the measured monitoring sample.

idSample, Sample

Yes

idAnalyticalMethod

AlphaNumeric (50)

The code of method of analysis.

idAnalyticalMethod, AnalyticalMethodName, AnalyticalMethodId

Yes

AnalysisDate

DateTime

Date of analysis.

AnalysisDate, DateAnalysis

No

Substance concentration(s)

AlphaNumeric (100)

Substance concentrations can be uploaded via the sample concentrations table or via additional columns of the sample analyses table. For the latter, one or more columns with the measured concentrations of the substances in the unit as specified by the analytical method should be included in the data table. The column name(s) should match the substance codes of the substances measured by the analytical methods. Empty fields for substances that should have been measured by the analytical method are considered to be censored with measurement values below LOQ or LOD.

No

Name

AlphaNumeric (100)

Name of the human monitoring sample analysis.

Name

No

Description

AlphaNumeric (200)

Additional description of the human monitoring sample analysis.

Description

No

Sample concentrations

The positive concentration values for substances from analysis in the unit specified in table human monitoring sample analyses. Censored values (i.e. results ‘less than LOR’) are not included, their existence can be inferred from the tables AnalysisSamples and AnalyticalMethodSubstances, and the LOR itself from the analytical method.

Accepted table names: HumanMonitoringSampleConcentrations, HumanMonitoringSampleConcentration, HumanMonitoringConcentrations.

Table 137 Table definition for Sample concentrations.
Name Type Description Aliases Required

idAnalysisSample

AlphaNumeric (50)

The identification number of the analysed sample.

idAnalysisSample, AnalysisSampleId

Yes

idSubstance

AlphaNumeric (50)

The substance code.

idSubstance, SubstanceId, Substance

Yes

Concentration

Numeric

The measured concentration.

Concentration

No

ResType

ResType

The type of residue. Should be VAL (= default), LOQ, LOD or MV.

ResType

No

PARC HBM data format

The PARC HBM data format is the data format proposed in the EU Partnership for the Assessment of Risks from Chemicals (PARC) project. MCRA supports upload of files in this format, of which the data is mapped to the MCRA internal data format during the upload of the files.