Quantitative response assay documents

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Quantitative response assay
.... Name
.... Identification
.... Date
.... Documentation
........ Assay purpose
........ User instruction
........ Alternatives
............ Substance name
............ Substance reference
........ Substance identification
........ Substance batch/lot number
........ Substance sub-batch/sub-lot number
........ Substance variant
........ Substance class
........ Substance description
........ Operator
............ Alternatives
................ Operator name
................ Operator reference
.................... Config
........................ Update mode
............ Role
........ Reagent
............ Alternatives
................ Reagent name
................ Reagent reference
............ Reagent identification
............ Reagent batch/lot number
............ Reagent sub-batch/sub-lot number
............ Reagent variant
............ Reagent class
............ Reagent description
............ Amount
........ Equipment
............ Alternatives
................ Equipment name
................ Equipment reference
.................... Config
........................ Update mode
........ User variable
............ Key
............ Value
........ Data source
............ File name
............ Import time stamp
............ Import module identification
............ Import comment
.... Setup
........ Assay elements
............ Standard sample
................ Name
................ Observation group ID
................ Preparation scheme
................ Data selection scheme
................ Display color
................ User variable
.................... Key
.................... Value
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
............ Test sample
................ Name
................ Observation group ID
................ Preparation scheme
................ Data selection scheme
................ Display color
................ User variable
.................... Key
.................... Value
................ Group
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Expected relative potency
................ Exclude from analysis / invalid assay element
............ Control sample
................ Name
................ Observation group ID
................ Preparation scheme
................ Data selection scheme
................ Display color
................ User variable
.................... Key
.................... Value
................ Group
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Expected relative potency
................ Exclude from analysis / invalid assay element
............ Control line
................ Name
................ Observation group ID
................ Preparation scheme
................ Data selection scheme
................ Display color
................ User variable
.................... Key
.................... Value
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Exclude from analysis / invalid assay element
........ Preparation schemes
............ Preparation scheme
................ Name
................ Replicate count
................ Alternatives
.................... Absolute potency: Not defined
.................... Absolute potency: Defined by raw material
........................ Assigned/assumed potency (summary)
............................ Assigned/assumed potency
............................ Assigned/assumed potency units
........................ Amount (summary)
............................ Amount
............................ Amount units
........................ Solvent (summary)
............................ Solvent volume
............................ Solvent volume units
.................... Absolute potency: Defined by stock solution
........................ Assigned/assumed potency
........................ Assigned/assumed potency units
................ Predilution factors
.................... Predilution factor
................ Alternatives
.................... Geometric sequence
........................ Number of steps
........................ Initial value
........................ Base
.................... Linear sequence
........................ Number of steps
........................ First dose
........................ Delta
.................... Defined sequence
........................ Dose value
.................... Stepwise dilution sequence
........................ Initial value
........................ Dilution factor
........ Observation data
............ Observation source
............ Document reference
................ Name
................ Column key
................ Edit mode
................ Update mode
................ Document type
................ Template key
................ Folder key
................ Allow subfolder
................ Generator key
................ Document mode
................ Document property filter
................ Section property filter
............ Column: Section
................ Name
................ Column key
................ Property filter
............ Row order
............ Column: Observation group
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
................ Maximal group number
............ Column: Sequence step
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
................ Concentration unit
............ Column: Response value
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
................ Unit
............ Column: Technical-outlier flag
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
............ Column: Position factor
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
................ Number of positions
................ Map index to characters
............ Alternatives
................ Column: Boolean
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
................ Column: Date
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
................ Column: Date/time
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
................ Column: Floating point number
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
................ Column: Integer
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
................ Column: Memo (multiline text)
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
................ Column: Text
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
................ Column: Time
.................... Name
.................... Column key
.................... Property scope
.................... Property key
.................... Section key
.... Analysis
........ Response data processing
............ Difference of responses
................ First response column
................ Second response column
............ Alternatives
................ Adjustment
.................... Alternatives
........................ No adjustment
........................ by Fixed value
........................ by Control line
............................ Control line
........................ Block-based by Control line
............................ Control line
............................ Block factor
................ Normalization
.................... Alternatives
........................ No normalization
........................ by Fixed value
........................ by Control line
............................ Control line
........................ Block-based by Control line
............................ Control line
............................ Block factor
................ Transformation
.................... Alternatives
........................ No transformation
........................ Logarithmic response transformation
............................ Logarithm base
........................ Square response transformation
........................ Square root response transformation
................ Replicate averaging
.................... Alternatives
........................ Deactivated
........................ Activated
........ Analytical model
............ Response value upper limit
............ Response value lower limit
............ Alternatives
................ Model: Linear parallel-line
................ Model: 4-parameter logistic fit
.................... Include control line
................ Model: 5-parameter logistic fit
................ Model: 3-parameter logistic fit with fixed lower asymptote
.................... Alternatives
........................ Asymptote fixed by control line
........................ Asymptote fixed by value
................ Model: 3-parameter logistic fit with fixed upper asymptote
.................... Alternatives
........................ Asymptote fixed by control line
........................ Asymptote fixed by value
................ Model: Slope ratio
.................... Include control line
............ Simultaneous regression
............ Potency estimation confidence level
............ Calculate mean potency estimate of test samples
............ Advanced settings
................ ANOVA model
................ ANOVA block effects
.................... Block factor
................ Logarithm base
................ Invert potency
................ Report excluded/invalid elements
................ Potency confidence interval calculation method
................ Coefficient of determination
................ Deactivate reduced accuracy fit
........ Data selection schemes
............ Configuration optimizer allocation range
............ Quality weight
............ Outlier processing
............ Data selection scheme
................ Name
................ Alternatives
.................... No outlier detection
.................... Dixon test
........................ Alpha
........................ Recursive
........................ Operational sequence
.................... Grubbs test
........................ Alpha
........................ Recursive
........................ Operational sequence
.................... (Externally) studentized residuals test
........................ Alpha
........................ Recursive
.................... Standard deviation test
........................ n Sigma
........................ Operational sequence
................ Alternatives
.................... Range full
.................... Range partial
........................ Step start
........................ Step stop
................ Alternatives
.................... Optimization off
.................... Optimization on
........................ Restrict selection
........................ Alternatives
............................ Ignore 50-percent response
............................ Include 50-percent response
................................ Use response transformation
................................ Estimation by
........................ Alternatives
............................ Minimal number of steps
............................ Exact number of steps
........ Suitability tests
............ Test exception handling
............ Test system reference
................ Config
.................... Update mode
............ Assay suitability tests
................ Alternatives
.................... F-test (hypothesis test)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Type
........................ Alternatives
............................ Confidence level (%)
............................ p
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Parameter estimate
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Difference of parameter estimates
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Ratio of parameter estimates
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Scaled parameter range
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Scaling parameter
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Point estimate test: Parameter estimate
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Point estimate test: Difference of parameter estimates
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Point estimate test: Ratio of parameter estimates
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Normalized difference of asymptotes
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Sum of squares regression
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Sum of squares non-parallelism
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Sum of squares non-linearity
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
........................ Rounding
.................... Test: Ratio sum of squares non-linearity / sum of squares regression
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency value
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Potency type
........................ Rounding
.................... Test: Potency confidence interval
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Potency type
........................ Rounding
.................... Test: Log potency range (L-value)
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency of intermediate dilution
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ No. of dilution factor
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency confidence interval (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency range (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Weight (W)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Maximal number of outliers
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
.................... Test: Maximal sequence step CV (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Minimal R²
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
........................ Rounding
.................... Test: Relative LOF error (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Response value range
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Root mean square error (RMSE)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
........................ Rounding
............ Sample suitability tests
................ Alternatives
.................... F-test (hypothesis test)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Type
........................ Alternatives
............................ Confidence level (%)
............................ p
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Parameter estimate
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Difference of parameter estimates
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Ratio of parameter estimates
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Equivalence test: Scaled parameter range
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Scaling parameter
........................ Confidence level (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Point estimate test: Parameter estimate
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Point estimate test: Difference of parameter estimates
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Point estimate test: Ratio of parameter estimates
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Normalized difference of asymptotes
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Sum of squares regression
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Sum of squares non-parallelism
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Sum of squares non-linearity
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
........................ Rounding
.................... Test: Ratio sum of squares non-linearity / sum of squares regression
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency value
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Potency type
........................ Rounding
.................... Test: Potency confidence interval
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Potency type
........................ Rounding
.................... Test: Log potency range (L-value)
........................ Parameter
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency of intermediate dilution
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ No. of dilution factor
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency confidence interval (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Potency range (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Weight (W)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Maximal number of outliers
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
.................... Test: Maximal sequence step CV (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Minimal R²
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
........................ Rounding
.................... Test: Relative LOF error (%)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Response value range
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Rounding
.................... Test: Root mean square error (RMSE)
........................ Test name
........................ Conditional evaluation
............................ Test reference
............................ Evaluation condition
........................ Upper margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
........................ Extent of the test
........................ Rounding
............ Document suitability tests
................ Signature state
.................... Number of signatures
.................... Meaning
.................... Scope of the test
.................... Severity level of the test
................ Test on user variable
.................... Key
.................... Value
.................... Severity level of the test
.... Settings
........ Graphics
............ Display horizontal lines
............ Display vertical lines
............ Display legend
............ Label of the x-axis
............ Label of the y-axis
.... Comment
........ Subject
........ Text
........ Linked document
........ Date
........ Author