Rendering of ODM Metadata. XSLT Stylesheet (R1.0.0)

Studies

Name	OID
CDISC Example Study	CES

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Study: CDISC Example Study

OID=CES

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Name	CDISC Example Study
Description	A simple trial to demonstrate the end-to-end application of the CDISC Standards
Protocol Name	CDISC Example Study

MetaData

Name	OID
CDISC Example Study Metadata	CES_MDV_V1

Study

MetaData: CDISC Example Study Metadata

OID=CES_MDV_V1

Study

Identifier	Mandatory	Skip Study Event condition	Forms	Skip Form condition
BASELINE	Yes		F_BASELINE
			F_CM
			F_LAB
			F_COMPLAINTS_REL_SMOKING	Use this form only if in the BaseLine form it is marked that the subject is smoking.
WEEK_1	Yes		F_WEEK_1_2
			F_LAB
WEEK_2	Yes		F_WEEK_1_2
			F_LAB
DIARY	Yes		F_DIARY
AE	No		F_AE
			F_CM

MetaData

Form: Baseline

OID=F_BASELINE

MetaData

Group: Common

OID=IG_COMMON, Repeating=No

Site number SITEID
Subject ID USUBJID
Visit Date RFSTDTC
Visit Start Time @SDSVarName Not Set	: :

Group: Demographics

OID=IG_DM, Repeating=No

Date of Birth BRTHDTC
Sex SEX	Male Female
Race RACE	Caucasian Black Asian Other

Group: Smoking History

OID=IG_SH, Repeating=No

Check when the subject is a smoker SUDOSE
Number of cigarettes per day @SDSVarName Not Set	Less Than 10 cigarettes per day 10 to 20 cigarettes per day Greater Than 20 cigarettes per day	Skip condition: Only to be collected if the subject is smoking

Group: Drinking history

OID=IG_DH, Repeating=No

Number of alcoholic drinks per day
SUDOSE

< 1
1-2
> 2

Group: Physical examination: Base

OID=IG_PE_BASE, Repeating=No

Height VSORRES Alias: SDTM: VSORRES where VSTESTCD=HEIGHT	( in )
Weight VSORRES Alias: SDTM: VSORRES where VSTESTCD=WEIGHT	( lbs )
Systolic blood pressure VSORRES Alias: SDTM: VSORRES where VSTESTCD=SYSBP	( mm Hg )
Diastolic blood pressure VSORRES Alias: SDTM: VSORRES where VSTESTCD=DIABP	( mm Hg )
Blood pressure ratio @SDSVarName Not Set	.	Method: Systolic blood pressure divided by diastolic blood pressure
Does the subject feel dizzy when standing up from a sitting position @SDSVarName Not Set	No Yes	Skip condition: Needs not be collected when the diastolic blood pressure is 90 or higher

Group: X-Ray

OID=IG_XRAY, Repeating=No

Server or File location of X-Ray photograph
@SDSVarName Not Set

Group: Complaints related to smoking

OID=IG_SMOKING_COMPLAINTS, Repeating=No

Skip condition: Use this group only if it is marked that the subject is smoking

Breathing @SDSVarName Not Set	No Yes
Coughing @SDSVarName Not Set	No Yes
Heart @SDSVarName Not Set	No Yes
No. of illness days last year @SDSVarName Not Set
Number of bronchitis cases during the last year @SDSVarName Not Set
Number of pneumonia cases last year @SDSVarName Not Set

MetaData

Form: Week 1 and 2

OID=F_WEEK_1_2

MetaData

Group: Common

OID=IG_COMMON, Repeating=No

Site number SITEID
Subject ID USUBJID
Visit Date RFSTDTC
Visit Start Time @SDSVarName Not Set	: :

Group: Physical Examination: Week

OID=IG_PE_WEEK, Repeating=No

Weight VSORRES Alias: SDTM: VSORRES where VSTESTCD=WEIGHT	( lbs )
Systolic blood pressure VSORRES Alias: SDTM: VSORRES where VSTESTCD=SYSBP	( mm Hg )
Diastolic blood pressure VSORRES Alias: SDTM: VSORRES where VSTESTCD=DIABP	( mm Hg )

MetaData

Form: Diary

OID=F_DIARY

MetaData

Group: Common

OID=IG_COMMON, Repeating=No

Site number SITEID
Subject ID USUBJID
Visit Date RFSTDTC
Visit Start Time @SDSVarName Not Set	: :

Group: Patient diary

OID=IG_PD, Repeating=Yes

Day QSDY	1 2 3 4 5 6 7
Date QSDTC
Discomfort Severity QSORRES	None Mild Moderate Severe

MetaData

Form: Adverse Events

OID=F_AE

MetaData

Group: Common

OID=IG_COMMON, Repeating=No

Site number SITEID
Subject ID USUBJID
Visit Date RFSTDTC
Visit Start Time @SDSVarName Not Set	: :

Group: Adverse events

OID=IG_AE_OCCURRED, Repeating=No

Has the subject experienced any adverse events
@SDSVarName Not Set

No
Yes

Group: Adverse events

OID=IG_AE, Repeating=Yes

Skip condition: Use this group only if it is marked that an adverse event occurred

Event No.
AESPID

Adverse event
AETERM

Start Date
AESTDTC

Is the adverse event still continuing
AEENRF

No
Yes

Stop Date
AEENDTC

Skip condition: Use this group only if it is marked that the adverse event is continueing

Duration of the adverse event
@SDSVarName Not Set

Years:

Months:

Days:

Hours:

Minutes:

Seconds:

Skip condition: Use this group only if it is marked that the adverse event is continueing

Was event serious
AESER

No
Yes

Severity
AESEV

Mild
Moderate
Severe

Skip condition: Not to be entered if marked that the AE was not serious

Is there a reasonable possibility that the AE may have been caused by the study drug
AEREL

No
Yes

Action taken with study drug
AEACN

None
Study drug regimen changed
Temporarily stopped study drug
Study drug discontinued

Subject outcome
AEOUT

Subject remains in study
Withdrawn from study
Lost to follow-up
Death

MetaData

Form: Prior or Concomitant Medications

OID=F_CM

MetaData

Group: Common

OID=IG_COMMON, Repeating=No

Site number SITEID
Subject ID USUBJID
Visit Date RFSTDTC
Visit Start Time @SDSVarName Not Set	: :

Group: Non-study related medication

OID=IG_CM_TAKEN, Repeating=No

Were any non-study medications taken
@SDSVarName Not Set

No
Yes

Group: Concomittant medication

OID=IG_CM, Repeating=Yes

Skip condition: Use this group only if it is marked that concurrent medication has been taken

Medication No. CMSPID
Drug Name (Brand or Generic) CMTRT
Total Dose Per Freqeuncy Checked CMDOSE
Unit CMDOSEU
Frequency CMDOSFRQ	Single Dose Daily Weekly Monthly PRN Other
Start Date CMSTDTC
Is medication still continuing CMENRF	No Yes
Stop Date CMENDTC		Skip condition: Use this group only if it is marked that concurrent medication is ongoing
Pre-existing illness No. CMINDC
Adverse Event No. CMINDC
Prophylaxis CMINDC	No Yes
Prophylaxis, Specify CMINDC		Skip condition: Use this group only if it is marked that there is prophylaxis

MetaData

Form: Laboratory

OID=F_LAB

MetaData

Group: Common

OID=IG_COMMON, Repeating=No

Site number SITEID
Subject ID USUBJID
Visit Date RFSTDTC
Visit Start Time @SDSVarName Not Set	: :

Group: Hematology Lab

OID=IG_LB_HEMATOLOGY, Repeating=No

Laboratory Name LBNAM
Laboratory ID @SDSVarName Not Set
Accession # @SDSVarName Not Set
Check when not done LBSTAT
Red Blood Count LBORRES	.	Skip condition: Not to be entered if marked that no Red Blood Count was done
Red Blood Count, Normal Range, Low LBORNRLO	.	Skip condition: Not to be entered if marked that no Red Blood Count was done
Red Blood Count, Normal Range, High LBORNRHI	.	Skip condition: Not to be entered if marked that no Red Blood Count was done
Check when not Done LBSTAT
White Blood Count LBORRES	.	Skip condition: Not to be entered if marked that no White Blood Count was done
White Blood Count, Normal Range, Low LBORNRLO	.	Skip condition: Not to be entered if marked that no White Blood Count was done
White Blood Count, Normal Range, High LBORNRHI	.	Skip condition: Not to be entered if marked that no White Blood Count was done

MetaData

Form: Complaints related to smoking - Do NOT use this form when the subject is a non-smoker

OID=F_COMPLAINTS_REL_SMOKING

MetaData

Group: Complaints related to smoking

OID=IG_SMOKING_COMPLAINTS, Repeating=No

Breathing @SDSVarName Not Set	No Yes
Coughing @SDSVarName Not Set	No Yes
Heart @SDSVarName Not Set	No Yes
No. of illness days last year @SDSVarName Not Set
Number of bronchitis cases during the last year @SDSVarName Not Set
Number of pneumonia cases last year @SDSVarName Not Set