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.

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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
OsmoticConcentration	Numeric	Osmotic concentration of the measured person for this particular sample.	Osm, OsmoticConcentration	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.