Library Properties

Version:1.0

Description:
A multi-center observational study to evaluate the safety and effectiveness of Cimzia (Certolizumab Peo) in adult...

Instructions:
Rheumatoid Arthritis (RA) and Crohn's Disease (CD)

Metadata Sources

CDASH_1.1.ODM.xml Pfizer CDASH 1.1 6 differences from edits

Pull from standards or similar studies

34 matches
L4C_RA0090 Adverse Event Show form

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090

Adverse Event
Show 4 variables Hide 4 variables

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of What Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of What Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?

Done

	Library	Sponsor	Therapeutic Area	Drug
Add	CDASH 1.1 Global Standard Standard	All Sponsors	Complicated Integrationitis	Aspirin HCL
Add	PAREXEL Global Standard Standard	All Sponsors	Complicated Integrationitis	Aspirin HCL
Add	Pfizer PDS Design Standard	Pfizer	Oncology	SII-246

Vital Signs \ Sitting Diastolic Blood Pressure

Dataset Name	Variable Name	Variable Label	Variable Type	Variable Format	Parameter Identifier	Codelist	Origin	Derivation / Comment
ADaM Derivation Rules
ADVS	VSTEST	Vital Signs Test Name	text	$40	ALL		Predecessor	VS.VSTEST
ADVS	VSTESTCD	Vital Signs Test Short Name	text	$40	ALL		Predecessor	VS.VSTESTCD
ADVS	VSORRES	Results in Original Units	text	$300	ALL		Predecessor	VS.VSPRRES
ADVS	VSPOS	Position of Subject	text	$40	ALL		Predecessor	VS.VSPOS
ADVS	VISITNUM	Visit Number	text	$40	ALL		Predecessor	VS.VISITNUM
ADVS	VSDTC	Date/Time of Measurement	text	$40	ALL		Predecessor	VS.VSDTC
ADVS	PARAM	Parameter	text	$40	DEFAULT	Diastolic Blood Pressure (mmHg) Systolic Blood Pressure (mmHg) Heart Rate (BEATS/MIN) Weight (kg) Height (cm)	Derived	Test (VS.VSTEST) and unit (VS.VSTESTU) as one string
ADVS	PARAM	Parameter	text	$40	BMI	BMI (kg/m^2)	Assigned	Additional rows for calculated BMI
ADVS	PARAMCD	Parameter Code	text	$40	DEFAULT	DIABP SYSBP HR WEIGHT HEIGHT	Predecessor	Test code (VS.VSTESTCD)
ADVS	PARAMCD	Parameter Code	text	$40	BMI	BMI	Assigned	Additional rows for calculated BMI
SDTM Derivation Rules
Dataset Name	Variable Name	Variable Label	Variable Type	Variable Format	Parameter Identifier	Codelist	Origin	Derivation / Comment
VS	VSTEST	Vital Signs Test Name	text	$40	ALL		Derived	If CRF field is DIABP, set to "Diastolic Blood Pressure"
VS	VSTESTCD	Vital Signs Test Short Name	text	$8	ALL		Derived	If CRF field is DIABP, set to "DIABP"
VS	VSORRES	Results in Original Units	text	$200	ALL		Derived	Value of DIABP CRF field
VS	VSORRESU	Units	text	$40	ALL		Derived	If CRF field is DIABP, set to "mmHg"
VS	VSPOS	Position of Subject	text	$40	ALL		Derived	If CRF field is DIABP, set to "Sitting"
VS	VISITNUM	Visit Number	float	8	ALL		Derived	Study visit number
VS	VSDTC	Date/Time of Measurement	datetime	$90	ALL		Derived	Study visit date/time (dd MMM yyyy)
CDASH Representation
Dataset Name	Variable Name	Variable Label	Variable Type	Variable Format	Parameter Identifier	Codelist
VS	DIABP	Sitting Diastolic Blood Pressure	Char	$3	ALL

Name	Status	Sponsor	Therapeutic Area	Drug/Study agent	Updated by	Last Update
L4C_RA0093	Development	All Sponsors	Endocrinology	Aspirin HCL	andreblack+2@sycmore...	2 months ago13 Nov 2014 04:17
L4C_RA0091	Development	PharmaCo	Musculoskeletal	NATALIZUMAB	pcda@pharma.com	2 months ago13 Nov 2014 04:17
STF115944	Development	PharmaCo	Autoimmune Disorders	Fabrizumab	pcda@pharma.com	2 months ago13 Nov 2014 04:17
NTT_RA0445	Development	PharmaCo	Complicated Integrationitis	Aspirin HCL	datasteward@pharma.com	2 months ago13 Nov 2014 04:17

ADaM Derivation Rules
ADVS	VSTEST	Vital Signs Test Name	text	$40	ALL		Predecessor	VS.VSTEST
ADVS	VSTESTCD	Vital Signs Test Short Name	text	$40	ALL		Predecessor	VS.VSTESTCD
ADVS	VSORRES	Results in Original Units	text	$300	ALL		Predecessor	VS.VSPRRES
ADVS	VSPOS	Position of Subject	text	$40	ALL		Predecessor	VS.VSPOS
ADVS	VISITNUM	Visit Number	text	$40	ALL		Predecessor	VS.VISITNUM
ADVS	VSDTC	Date/Time of Measurement	text	$40	ALL		Predecessor	VS.VSDTC
ADVS	PARAM	Parameter	text	$40	DEFAULT	Diastolic Blood Pressure (mmHg) Systolic Blood Pressure (mmHg) Heart Rate (BEATS/MIN) Weight (kg) Height (cm)	Derived	Test (VS.VSTEST) and unit (VS.VSTESTU) as one string
BMI	BMI (kg/m^2)	Assigned	Additional rows for calculated BMI
ADVS	PARAMCD	Parameter Code	text	$40	DEFAULT	DIABP SYSBP HR WEIGHT HEIGHT	Predecessor	Test code (VS.VSTESTCD)
BMI	BMI	Assigned	Additional rows for calculated BMI
VS	VSTEST	Vital Signs Test Name	text	$40	ALL		Derived	If CRF field is DIABP, set to "Diastolic Blood Pressure"
VS	VSTESTCD	Vital Signs Test Short Name	text	$8	ALL		Derived	If CRF field is DIABP, set to "DIABP"
VS	VSORRES	Results in Original Units	text	$200	ALL		Derived	Value of DIABP CRF field
VS	VSORRESU	Units	text	$40	ALL		Derived	If CRF field is DIABP, set to "mmHg"
VS	VSPOS	Position of Subject	text	$40	ALL		Derived	If CRF field is DIABP, set to "Sitting"
VS	VISITNUM	Visit Number	float	8	ALL		Derived	Study visit number
VS	VSDTC	Date/Time of Measurement	datetime	$90	ALL		Derived	Study visit date/time (dd MMM yyyy)
VS	DIABP	Sitting Diastolic Blood Pressure	Char	$3	ALL

ADaM Derivation Rules

Dataset Name

Variable Name

Variable Label

Variable Type

Variable Format

Parameter Identifier

Codelist

Origin

Derivation / Comment

ADVS

VSTEST

Vital Signs Test Name

text

$40

*ALL*

Predecessor

VS.VSTEST

ADVS

VSTESTCD

Vital Signs Test Short Name

text

$40

*ALL*

Predecessor

VS.VSTESTCD

ADVS

VSORRES

Results in Original Units

text

$300

*ALL*

Predecessor

VS.VSPRRES

ADVS

VSPOS

Position of Subject

text

$40

*ALL*

Predecessor

VS.VSPOS

ADVS

VISITNUM

Visit Number

text

$40

*ALL*

Predecessor

VS.VISITNUM

ADVS

VSDTC

Date/Time of Measurement

text

$40

*ALL*

Predecessor

VS.VSDTC

ADVS

PARAM

Parameter

text

$40

*DEFAULT*

Diastolic Blood Pressure (mmHg)
Systolic Blood Pressure (mmHg)
Heart Rate (BEATS/MIN)
Weight (kg)
Height (cm)

Derived

Test (VS.VSTEST) and unit (VS.VSTESTU) as one string

BMI

BMI (kg/m^2)

Assigned

Additional rows for calculated BMI

ADVS

PARAMCD

Parameter Code

text

$40

*DEFAULT*

DIABP SYSBP HR WEIGHT HEIGHT

Predecessor

Test code (VS.VSTESTCD)

BMI

Assigned

Additional rows for calculated BMI

SDTM Derivation Rules

Dataset Name

Variable Name

Variable Label

Variable Type

Variable Format

Parameter Identifier

Codelist

Origin

Derivation / Comment

VSTEST

Vital Signs Test Name

text

$40

*ALL*

Derived

If CRF field is DIABP, set to "Diastolic Blood Pressure"

VSTESTCD

Vital Signs Test Short Name

text

*ALL*

Derived

If CRF field is DIABP, set to "DIABP"

VSORRES

Results in Original Units

text

$200

*ALL*

Derived

Value of DIABP CRF field

VSORRESU

Units

text

$40

*ALL*

Derived

If CRF field is DIABP, set to "mmHg"

VSPOS

Position of Subject

text

$40

*ALL*

Derived

If CRF field is DIABP, set to "Sitting"

VISITNUM

Visit Number

float

*ALL*

Derived

Study visit number

VSDTC

Date/Time of Measurement

datetime

$90

*ALL*

Derived

Study visit date/time (dd MMM yyyy)

Form Variables

Dataset Name

Variable Name

Variable Label

Variable Type

Variable Format

Parameter Identifier

Codelist

DIABP

Sitting Diastolic Blood Pressure

Char

*ALL*

CDASH 1.1 Global Standard

Library Properties

Metadata Sources

Pull from standards or similar studies

34 matches

Select standards to incorporate

Clinical Concept Mapping CDASH RAVE Inform SDTM ADaM

Vital Signs \ Sitting Diastolic Blood Pressure

ADaM Derivation Rules

SDTM Derivation Rules

CDASH Representation

Changes would impact these 4 Libraries and SIMs: (Click to open in new tabs)

Mapping for variable Diastolic Blood Pressure in Vital Signs map as: Vital Sign Transformation mapping template Form variables to SDTM choose

ADaM Derivation Rules

SDTM Derivation Rules

Form Variables

Edit Value Set:

Find a code system

6 matches

Changes would impact these 4 Libraries and SIMs:
(Click to open in new tabs)

Mapping for variable Diastolic Blood Pressure in Vital Signs
map as: Vital Sign Transformation mapping template Form variables to SDTM choose