CONFIDENTIAL CDISC - Dataset Definitions Covance ...

CONFIDENTIAL

CDISC - Dataset Definitions Covance Pharmacometrics Template

SDTM Version: Version Date:

Covance Template Version: Version Date:

Client: Protocol Number: Covance Study Number: Prepared by: Date: Version:

STUDY SPECIFIC

3.1.2 39764

1.0 39933

Swedish Match AB SM 08-01 7694-105 Yuan Tian

3/4/2010 1

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CDISC

DM

DATASET DEFINITIONS

Variable Name

STUDYID DOMAIN USUBJID SUBJID RFSTDTC

RFENDTC

Variable Label

Study Identifier Domain Abbreviation Unique Subject Identifier Subject Identifier for the Study Subject Reference Start Date/Time

Subject Reference End Date/Time

Type

Char Char Char Char Char

Length

20 2 50 20 50

Controlled Terms or Format DM

ISO 8601

Char 50

ISO 8601

Origin

CRF Assigned CRF CRF CRF

CRF

SITEID INVID

INVNAM BRTHDTC AGE

AGEU SEX RACE

Study Site Identifier Investigator Identifier

Investigator Name Date/Time of Birth Age

Age Units Sex Race

Char 10 Char 20

Char 50 Char 50 Num 8

Char 10 Char 2 Char 50

ISO 8601

(AGEU) (SEX) *(RACE)

CRF CRF

CRF CRF Derived

Assigned CRF CRF

ETHNIC

Ethnicity

Char 25

*(ETHNIC)

CRF

ARMCD

Planned Arm Code

Char 20

*

Assigned

ARM

Description of Planned Arm

Char 200 *

Assigned

COUNTRY

Country

Char 3

(COUNTRY) ISO 3166 Assigned

DMDTC

Date/Time of Collection

Char 50

ISO 8601

CRF

DMDY

Study Day of Collection

Num 8

Derived

* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value)

If permissible field is not collected on CRF it will be null in the dataset

Role

Identifier Identifier Identifier Topic Record Qualifier

Record Qualifier

Record Qualifier Record Qualifier

Synonym Qualifier Record Qualifier Record Qualifier

Variable Qualifier Record Qualifier Record Qualifier

Record Qualifier Record Qualifier Synonym Qualifier Record Qualifier Timing Timing

Mapping Notes/Comments

Core

Protocol Number as specified in Protocol.

Req

Domain name.

Req

Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID.

Req

Subject No from CRF

Req

First dosing date and time from CRF (null for screen failure subjects and subjects Exp

not receiving study drug).

Discharge Date from CRF or last dose date and time from CRF if

Exp

discharge/completion date not available (null for screen failure subjects and

subjects not receiving study drug).

Site Number identified on CRF. Otherwise=001..

Req

An identifier to describe the Investigator for the study. May be used in addition Perm

to SITEID. Not needed if SITEID is equivalent to INVID.

Investigator name from CRF.

Perm

Date of Birth from CRF.

Perm

Age from CRF, age calculated from OC, or derived age calculated using birth Exp

date and RFSTDTC from CRF.

"YEARS" unless otherwise noted.

Exp

M/F/U as specified on CRF.

Req

Race from CRF. If mixed/multiple races then RACE = 'MULTIPLE' or if race Exp

other is checked then RACE = 'OTHER' and additional race information goes

into SUPPDM. If race from CRF is missing, then RACE = 'UNKNOWN'. Race

is null if CRF does not collect race

Ethnicity from CRF or null.

Perm

Short name for ARM.

Req

Name of the Arm to which the subject was assigned.

Req

Country code of the investigational site in which the trail was conducted.

Req

Date/time of demographic data collection.

Perm

DMDTC-RFSTDTC. If >= 0 then add one.

Perm

In Dataset? Yes Yes Yes Yes Yes

Yes

Yes Yes

Yes Yes Yes

Yes Yes Yes

Yes Yes Yes Yes Yes Yes

Covance

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CDISC

CO

DATASET DEFINITIONS

Variable Name

STUDYID DOMAIN RDOMAIN

USUBJID COSEQ

IDVAR

Variable Label

Study Identifier Domain Abbreviation Related Domain Abbreviation

Unique Subject Identifier Sequence Number

Identifying Variable

Type

Char Char Char

Length

20 2 2

Controlled Terms or Format

CO *

Char 50 Num 8

Char 8

*

Origin

CRF Assigned Assigned

CRF Derived

Derived

IDVARVAL

Identifying Variable Value

Char 50

Assigned

COREF COVAL

COVAL1

COEVAL

Comment Reference Comment

Comment

Evaluator

Char 100 Char 200

Char 200

Char 50

*(EVAL)

CRF CRF

CRF

Assigned

CODTC

Date/Time of Comment

Char 50

ISO 8601

CRF

EPOCH

Epoch

Char 50

*

Derived

VISITNUM

Visit Number

Num 8

Derived

VISIT

Visit Name

Char 100

Protocol

VISITDY

Planned Study Day of Visit

Num 8

Derived

* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value)

If permissible field is not collected on CRF it will be null in the dataset

Role Identifier Identifier Identifier Identifier Identifier Identifier

Identifier

Record Qualifier Result Qualifier Result Qualifier Record Qualifier

Timing Timing Timing Timing Timing

Mapping Notes/Comments

Core

Protocol Number as specified in Protocol.

Req

Domain name.

Req

Domain abbreviation of the parent record(s). Null for comments collected on a Perm

general comments or additional information CRF page.

Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID.

Req

Subject level derived sequence number assigned to ensure uniqueness of subject's Req

record within a domain. Must be any valid number.

Identifying variable in the parent dataset that identifies the record(s) to which the Perm

comment applies. Examples AESEQ or CMGRPID. Used only when individual

comments are related to domain records. Null for comments collected on separate

CRFs.

Value of identifying variable of the parent record(s). Used only when individual Perm

comments are related to domain records. Null for comments collected on separate

CRFs.

Text identifier for reference associated with the comment.

Perm

The text of the comment. Text over 200 characters can be added to additional Req

columns COVAL1-COVALn.

The text of the comment. Text over 200 characters can be added to additional Req

columns COVAL1-COVALn.

Used to describe the originator of the comment if known. Examples: CENTRAL, Perm

REVIEWER, ADJUDICATION COMMITTEE, PRINCIPAL INVESTIGATOR.

In Dataset? Yes Yes Yes

Yes Yes

Yes

Yes

Yes Yes

Yes

Yes

Date/time of comment on dedicated comment form. Should be null if this is a Perm Yes

child record of another domain or if comment date was not collected.

Trial Epoch of the related comment record defined by the trail design domains (if Perm Yes

created). Examples: SCREENING, TREATMENT PHASE, FOLLOW-UP.

Clinical encounter number. Numeric version of VISIT, used for sorting.

Perm Yes

Protocol-defined description of clinical encounter.

Perm Yes

Planned study day of the visit based upon RFSTDTC in Demographics.

Perm Yes

Covance

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CDISC

SE

DATASET DEFINITIONS

Variable Name

STUDYID DOMAIN USUBJID SESEQ

ETCD

Variable Label

Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number

Element Code

Type

Char Char Char Num

Length

20 2 50 8

Controlled Terms or Format

SE

Char 8

*

Origin

CRF Assigned CRF Derived

Assigned

ELEMENT

Description of Element

Char 40

*

Derived

SESTDTC SEENDTC TAETORD

EPOCH

SEUPDES

Start Date/Time of Element

Char 50

End Date/Time of Element

Char 50

Planned Order of Elements with Arm Num 8

Epoch

Char 50

Description of Unplanned Element Char 200

ISO 8601 ISO 8601

*

Derived Derived Derived

Derived

Derived

* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Role Identifier Identifier Identifier Identifier Topic

Synonym Qualifier

Timing Timing Timing Timing Synonym Qualifier

Mapping Notes/Comments

Core

Protocol Number as specified in Protocol.

Req

Domain name.

Req

Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID.

Req

Subject level derived sequence number assigned to ensure uniqueness of subject's Req

record within a domain. Must be any valid number.

Req

1. Short name of ELEMENT, used for programming and sorting.

2. If an encountered Element differs from the planned Element to the point that it

is considered a new Element, then use 'UNPLAN' as the value for ETCD to

represent this Element.

The name of the Element as defined in the protocol. The element defines the Perm

high-level phase or windows within TV.VISIT. (e.g. SCREENING, DOSING

PHASE CHECK-IN, DOSING PHASE, WASH-OUT, END OF STUDY,

UNPLANNED).

Start date/time for an Element for each subject.

Req

End date/time for an Element for each subject.

Exp

Number that gives the planned order of the Element within the subject's assigned Perm

ARM.

Epoch associated with the Element in the planned sequence of Elements for the Perm

ARM to which the subject was assigned.

Description of what happened to the subject during this unplanned Element.

Perm

Used only if ETCD has the value of 'UNPLAN'. See examples for assignment of -

-UPDES.

In Dataset? Yes Yes Yes Yes Yes

Yes

Yes Yes Yes Yes Yes

Covance

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CDISC

SV

DATASET DEFINITIONS

Variable Name

STUDYID DOMAIN USUBJID VISITNUM VISIT VISITDY SVSTDTC SVENDTC SVSTDY SVENDY SVUPDES

Variable Label

Study Identifier Domain Abbreviation Unique Subject Identifier Visit Number Visit Name Planned Study Day of Visit Start Date/Time of Visit End Date/Time of Visit Study Day of Start of Visit Study Day of End of Visit Description of Unplanned Visit

Type

Char Char Char Num Char Num Char Char Num Num Char

Length

20 2 50 8 100 8 50 50 8 8 200

Controlled Terms or Format SV

ISO 8601 ISO 8601

Origin

CRF Assigned CRF Derived Protocol Derived CRF CRF Derived Derived Derived

* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Role

Mapping Notes/Comments

Identifier Identifier Identifier Timing Timing Timing Timing Timing Timing Timing Synonym Qualifier

Protocol Number as specified in Protocol. Domain name. Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID. Clinical encounter number. Numeric version of VISIT, used for sorting. Protocol-defined description of clinical encounter. Planned study day of the visit based upon RFSTDTC in Demographics. Start date/time for a Visit. End date/time of a Visit. SVSTDTC-RFSTDTC. If >= 0 then add one. SVENDTC-RFSTDTC. If >= 0 then add one. Description of what happened to the subject during an unplanned visit. See examples for assignment of --UPDES.

Core

Req Req Req Perm Perm Perm Exp Exp Perm Perm Perm

In Dataset? Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Covance

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CDISC

CM

DATASET DEFINITIONS

Variable Name STUDYID DOMAIN USUBJID CMSEQ

CMGRPID

CMSPID

CMTRT

CMMODIFY CMDECOD CMCAT

CMSCAT

CMPRESP

CMOCCUR

CMSTAT

CMREASND

CMINDC CMCLAS

CMCLASCD

CMDOSE CMDOSTXT

CMDOSU CMDOSFRM CMDOSFRQ

CMDOSTOT

CMDOSRGM CMROUTE CMSTDTC CMENDTC CMSTDY CMENDY CMDUR

Variable Label Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number

Group ID

Sponsor-Defined Identifier

Reported Name of Drug, Med, or Therapy Modified Reported Name Standardized Medication Name Category for Medication

Subcategory for Medication

CM Pre-Specified

CM Occurrence

Completion Status

Reason Medication Not Collected

Indication Medication Class

Medication Class Code

Dose per Administration Dose Description

Dose Units Dose Form Dosing Frequency Per Interval

Total Daily Dose

Intended Dose Regimen Route of Administration Start Date/Time of Medication End Date/Time of Medication Study Day of Start of Medication Study Day of End of Medication Duration of Medication

Type

Char Char Char Num

Length

20 2 50 8

Controlled Terms or Format

CM

Char 40

Char 40

Origin

CRF Assigned CRF Derived

Derived/CRF

Derived/CRF

Char 200

Char 200 Char 100 Char 50

Char 50

Char 2

Char 2

* * * (NY) (NY)

CRF

Assigned Assigned CRF

CRF

Assigned

CRF

Char 8

Char 200

Char 200 Char 50

(ND) *

Derived/CRF

CRF

CRF Assigned

Char 20

*

Assigned

Num 8 Char 50

Char 40 Char 50 Char 50

*(UNIT) *(FRM) *(FREQ)

CRF Derived/CRF

CRF CRF CRF

Num 8

Derived/CRF

Char 100 Char 50 Char 50 Char 50 Num 8 Num 8 Char 50

*(ROUTE) ISO 8601 ISO 8601

ISO 8601

CRF/Protocol CRF CRF CRF Derived Derived CRF

Role

Identifier Identifier Identifier Identifier

Identifier

Mapping Notes/Comments

Core

Protocol Number as specified in Protocol.

Req

Domain name.

Req

Concatenation of DM.STUDYID-DM.SITEID-DM.SUBJID.

Req

Sequence Number given to ensure uniqueness of subject records within a

Req

domain. May be any valid number.

Populated with value to identify or group together related records as appropriate. Perm

In Dataset? Yes Yes Yes Yes

Yes

Identifier Topic

Sponsor-defined reference number. Examples: a number pre-printed on the CRF Perm Yes

as an explicit line identifier or record identifier defined in the operational

database. Example: line number on a concomitant medication page.

Verbatim medication name that is either pre-printed or collected on a CRF.

Req Yes

Synonym Qualifier Synonym Qualifier Grouping Qualifier Grouping Qualifier Record Qualifier Record Qualifier

Record Qualifier Record Qualifier Record Qualifier Variable Qualifier

Variable Qualifier

Record Qualifier Record Qualifier Variable Qualifier Record Qualifier Variable Qualifier

Revised Drug Name if collected.

Perm Yes

Preferred Term from WhoDrug.

Perm Yes

"PREVIOUS MEDICATION" or "CONCOMITANT MEDICATION" from Perm Yes

CRF.

A further categorization of medication/treatment. Examples:

Perm Yes

CHEMOTHERAPY, HORMONAL THERAPY, ALTERNATIVE THERAPY.

Used to indicate whether (Y/null) information about the use of a specific

Perm Yes

medication was solicited on the CRF.

When the use of specific medications is solicited, CMOCCUR is used to indicate Perm Yes

whether or not (Y/N) use of the medication occurred. Values are null for

medications not specifically solicited.

Used to indicate that a question about a pre-specified medication was not

Perm Yes

answered. Should be null or have a value of NOT DONE.

Describes the reason concomitant medication was not collected. Used in

Perm Yes

conjunction with CMSTAT when value is NOT DONE.

Indication from CRF.

Perm Yes

Dictionary-derived drug class. When coding to a single class, populate with class Perm Yes

value. If using a dictionary and coding to multiple classes, then omit CMCLAS

and add values to SUPPCM.

Dictionary-derived code corresponding to CMCLAS. When coding to a single Perm Yes

class, populate with class code. If using a dictionary and coding to multiple

classes, then omit CMCLAS and add values to SUPPCM.

Numerical Dose from CRF.

Perm Yes

Dosing amounts or a range of dosing information collected in text form. If

Perm Yes

CMDOSE is non-numeric then populated.

Units from CRF.

Perm Yes

Dose form for CMTRT.

Perm Yes

Usually expressed at the number of repeated administrations of CMDOSE within Perm Yes

a specified time period. Examples: BID (twice daily), Q12H (every 12 hours).

Record Qualifier

Variable Qualifier Variable Qualifier Timing Timing Timing Timing Timing

Total daily dose of CMTRT using the units in CMDOSU. Total dose over a

Perm Yes

period other than day could be recorded in a separate Supplemental Qualifier

variable. CMDOSTOT should be used in addition to CMDOSE, and not in place

of it.

Regimen from CRF, if collected or derived from protocol.

Perm Yes

Route from CRF.

Perm Yes

Start Date/Time from CRF.

Perm Yes

Stop Date/Time from CRF.

Perm Yes

CMSTDTC-RFSTDTC. If >= 0 then add one.

Perm Yes

CMENDTC-RFSTDTC. If >= 0 then add one.

Perm Yes

Collected duration of medication in ISO 8601 format. Used only if collected on Perm Yes

the CRF and not derived from start and end date/times.

Covance

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CDISC

CM

Variable Name CMSTRF

Variable Label Start Relative to Reference Period

Type Char

Length Controlled Terms or

Format

40

(STENRF)

Origin Derived

CMENRF

End Relative to Reference Period

Char 40

(STENRF)

Derived

CMSTRTPT

CMSTTPT CMENRTPT

Start Relative to Reference Time Point Char 40

Start Reference Time Point

Char 40

End Relative to Reference Time Point Char 50

BEFORE, COINCIDENT, Derived AFTER, U

Derived

BEFORE, COINCIDENT, Derived AFTER, ONGOING, U

CMENTPT

End Reference Time Point

Char 50

Derived

* Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI code-list code value) If permissible field is not collected on CRF it will be null in the dataset

Role Timing

Timing

Timing Timing Timing

Timing

DATASET DEFINITIONS

Mapping Notes/Comments

CMSTRF = "BEFORE" when CMSTDTC < RFSTDTC CMSTRF = "AFTER" when CMSTDTC > RFENDTC CMSTRF = "DURING" when RFSTDTC ................
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