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The controlled terminology in this spreadsheet supports Analysis Data Model Implementation Guide Version 1.

0
(ADaMIG v1.0).
Column

Code (Column A)

Codelist Code (Column B)

Codelist Extensible (Yes/No) (Column C)

Codelist Name (Column D)

CDISC Submission Value (Column E)

CDISC Synonym(s) (Column F)

CDISC Definition (Column G)

NCI Preferred Term (Column H)


in this spreadsheet supports Analysis Data Model Implementation Guide Version 1.0
(ADaMIG v1.0).
Description

Unique numeric code randomly generated by NCI Thesaurus (NCIt) and assigned
to individual CDISC controlled terms.

Unique numeric code assigned to the ADaM parent codelist names. This code is
repeated for each controlled term (aka permissible value) belonging to a codelist.
**NOTE - light blue highlighting is used to identify the beginning of a new ADaM
codelist and its applicable term set.

Defines if controlled terms may be added to the codelist. New terms may be
added to existing codelist values as long as they are not duplicates or synonyms
of existing terms. The expectation is that sponsors will use the published
controlled terminology as a standard baseline and codelists defined as
“extensible” (or "Yes") may have terms added by the sponsor internally.

Contains the descriptive name of the codelist which is also referred to as the
codelist label in the ADaM IG. As with the Codelist Code, the Codelist Name is
repeated for each controlled term belonging to a codelist.

IMPORTANT COLUMN: Currently this is the specific value expected for


submissions. Each value corresponds to an ADaM Codelist Name as indicated by
light blue shading.

This identifies the applicable synonyms for a CDISC Preferred Term in Column F.

This identifies the CDISC definition for a particular term. In many cases an
existing NCI definition has been used. The source for a definition is noted in
parentheses (e.g. NCI, CDISC glossary, FDA).

This identifies the NCI preferred name for a term as identified in NCIt. **NOTE -
This column designates the human readable, fully specified preferred term
corresponding to the NCI c-code, and is especially helpful for searching NCIt to
get the entire concept with links to all instances of the term.
Codelist
Codelist
Code Extensible Codelist Name
Code
(Yes/No)
C117745 Yes Analysis Purpose

C98724 C117745 Analysis Purpose

C98772 C117745 Analysis Purpose

C98781 C117745 Analysis Purpose

C117744 Yes Analysis Reason

C117750 C117744 Analysis Reason


C117751 C117744 Analysis Reason

C117752 C117744 Analysis Reason


C117753 C117744 Analysis Reason

C81223 No Date Imputation Flag

C81212 C81223 Date Imputation Flag


C81211 C81223 Date Imputation Flag
C81210 C81223 Date Imputation Flag
C81224 Yes Derivation Type

C81209 C81224 Derivation Type

C92225 C81224 Derivation Type

C81201 C81224 Derivation Type

C132340 C81224 Derivation Type

C92226 C81224 Derivation Type

C82866 C81224 Derivation Type

C139176 C81224 Derivation Type

C81208 C81224 Derivation Type


C81198 C81224 Derivation Type

C132341 C81224 Derivation Type

C132342 C81224 Derivation Type

C82868 C81224 Derivation Type

C82867 C81224 Derivation Type

C53331 C81224 Derivation Type

C81204 C81224 Derivation Type

C81207 C81224 Derivation Type

C81205 C81224 Derivation Type

C81200 C81224 Derivation Type

C81203 C81224 Derivation Type

C132343 C81224 Derivation Type

C81199 C81224 Derivation Type

C81206 C81224 Derivation Type

C81225 No Parameter Type

C81197 C81225 Parameter Type

C124296 Yes Subject Trial Status

C25250 C124296 Subject Trial Status

C25484 C124296 Subject Trial Status


C53279 C124296 Subject Trial Status

C81226 No Time Imputation Flag

C81213 C81226 Time Imputation Flag


C81214 C81226 Time Imputation Flag
C81215 C81226 Time Imputation Flag
CDISC Submission Value CDISC Synonym(s)

ANLPURP Analysis Purpose

EXPLORATORY OUTCOME MEASURE Exploratory Outcome Measure

PRIMARY OUTCOME MEASURE Primary Outcome Measure

SECONDARY OUTCOME MEASURE Secondary Outcome Measure

ANLREAS Analysis Reason

DATA DRIVEN
REQUESTED BY REGULATORY AGENCY

SPECIFIED IN PROTOCOL
SPECIFIED IN SAP

DATEFL Date Imputation Flag

D
M
Y
DTYPE Derivation Type

AVERAGE

BC

BLOCF

BOC

BOCF

ENDPOINT

EXTRAP

INTERP
LOCF

LOV

LVPD

MAXIMUM

MINIMUM

ML

MOTH

MOV

POCF

SOCF

WC

WOC

WOCF

WOV

PARAMTYP Parameter Type

DERIVED

SBJTSTAT Subject Trial Status

COMPLETED

DISCONTINUED
ONGOING Continuous

TIMEFL Time Imputation Flag

H
M
S
CDISC Definition

Purpose of a specific analysis result described in ADaM analysis results


metadata.
Exploratory measures that will be used to evaluate the intervention(s) or, for
observational studies, that are exploratory of the study.
The primary measurement(s) or observation(s) used to measure the effect of
experimental variables in a study, or for observational studies, to describe
patterns of diseases or traits or associations with exposures, risk factors or
treatment. These are the outcome measures used to assess the primary
objective(s).
Other key measures that will be used to evaluate the intervention(s) or, for
observational studies, that are a focus of the study. These are the outcome
measures used to assess the secondary objective(s).
Reason for reporting a specific analysis result described in ADaM analysis
results metadata.
The analysis was triggered by findings in the data.
The analysis has been requested by a regulatory agency.

The analysis is specified in a protocol.


The analysis is specified in a statistical analysis plan.

Date Imputation Flag: Indicates the level of imputation reflected in a date value.

Day Imputed: Day is imputed.


Month Imputed: Month and day are imputed.
Year Imputed: Entire date (year, month and day) is imputed.
Derivation Type: Analysis value derivation method.

Average: A data derivation technique which calculates a subject's average value


over a defined set of records.
Best Case: A data imputation technique which populates missing values with
the best possible outcome.
Baseline Observation Carried Forward: A data imputation technique which
populates missing values with the subject's nonmissing baseline observation.

Best Observed Case: A data imputation technique which populates analysis


values with the best outcome recorded within a subject.
Best Observation Carried Forward: A data imputation technique which
populates missing values with the subject's previous best-case nonmissing
value.
Endpoint: A data derivation technique which populates a subject's analysis end
point value.
A method of imputation involving populating an analysis value that is outside the
range of observed values and is estimated by a function of those observed
values.
Interpolation: A method of imputation involving a missing value that is between
known values and is estimated by a function of those known values.
Last Observation Carried Forward: A data imputation technique which populates
missing values with the subject's previous nonmissing value.
Last Observed Value: A data imputation technique which populates analysis
values with the subject's last recorded nonmissing observation.
Last Value Prior to Dosing: A data imputation technique which populates
missing values with the subject's last observed value prior to the start of study
treatment.
Maximum: A technique which populates an analysis value with a subject's
maximum value over a defined set of records.
Minimum: A technique which populates an analysis value with a subject's
minimum value over a defined set of records.
Maximum Likelihood: A data imputation technique which populates missing
values with estimates that maximize the probability of observing what has in
fact been observed.
Mean of Other Group: A data imputation technique which populates missing
values with the mean value from a comparator or reference group.
Mean Observed Value in a Group: A data imputation technique which populates
missing values with the mean value observed in a group of subjects.

Penultimate Observation Carried Forward: A data imputation technique which


populates missing values with the subject's next-to-last nonmissing value.

Screening Observation Carried Forward: A data imputation technique which


populates missing values with the subject's nonmissing screening observation.

Worst Case: A data imputation technique which populates analysis values with
the worst possible outcome.
Worst Observed Case: A data imputation technique which populates analysis
values with the worst recorded outcome within a subject.
Worst Observed Value Carried Forward: A data imputation technique which
populates missing values with the subject's worst-case nonmissing observation.

Worst Observed Value in a Group: A data imputation technique which populates


missing values with the worst value observed in a group of subjects.

Parameter Type: Indicates whether the parameter is derived as a function of


one or more other parameters.
Derived: Indicates that a parameter is derived as a function of one or more
other parameters.
Indicates the status of the subject in the trial.

To possess every necessary or normal part or component or step; having come


or been brought to a conclusion. (NCI)
To stop or end, permanently or temporarily.
Remain in force or carry on without letup; keep or maintain in unaltered
condition; exist in time or space without stop or interruption. (NCI)
Time Imputation Flag: Indicates the level of imputation reflected in a time value.

Hours Imputed: Entire time (hours, minutes and seconds) is imputed.


Minutes Imputed: Minutes and seconds are imputed.
Seconds Imputed: Seconds are imputed.
NCI Preferred Term

CDISC ADaM Analysis Purpose


Terminology
Exploratory Outcome Measure

Primary Outcome Measure

Secondary Outcome Measure

CDISC ADaM Analysis Reason


Terminology
Data Driven Analysis
Analysis Requested by Regulatory Agency

Analysis Specified in Protocol


Analysis Specified in Statistical Analysis
Plan
CDISC ADaM Date Imputation Flag
Terminology
Day Imputed
Month Day Imputed
Year Month Day Imputed
CDISC ADaM Derivation Type Terminology

Average of Value Derivation Technique

Best Case Imputation Technique

Baseline Observation Carried Forward


Imputation Technique

Best Observed Case Imputation Technique

Best Observation Carried Forward


Imputation Technique

Endpoint Value Derivation Technique

Extrapolation Imputation Technique

Interpolation Imputation Technique


Last Observation Carried Forward
Imputation Technique
Last Observed Value Imputation Technique

Last Value Prior to Dosing Imputation


Technique

Maximum Value Derivation Technique

Minimum Value Derivation Technique

Maximum Likelihood Estimation

Mean of Other Group Imputation Technique

Mean Observed Value in a Group


Imputation Technique

Penultimate Observation Carried Forward


Imputation Technique

Screening Observation Carried Forward


Imputation Technique

Worst Case Imputation Technique

Worst Observed Case Imputation


Technique
Worst Observation Carried Forward
Imputation Technique

Worst Observed Value in a Group


Imputation Technique

CDISC ADaM Parameter Type Terminology

Derived Flag

CDISC ADaM Subject Trial Status


Terminology
Complete

Discontinue
Continue

CDISC ADaM Time Imputation Flag


Terminology
Hours Minutes Seconds Imputed
Minutes Seconds Imputed
Seconds Imputed