Clinical Observations (CL)

Example

Unable to render {include} The included page could not be found.

Example

Unable to render {include} The included page could not be found.

Example

This example shows clinical signs captured in the collection system using no categorization by CLCAT or CLTEST and having result categorization applied after collection for reporting purposes. CLTESTCD and CLTEST are recorded as simply "Clinical Sign", and CLRESCAT is used to categorize each result.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLRESCAT	CLLOC	CLDTC	CLDY	CLNOMDY
1	13456	CL	13456-01	1	CS	Clinical Sign	CLINICAL SIGNS	Difficulty Walking	Difficulty Walking	CNS		2003-01-20T15:44:42	7	7
2	13456	CL	13456-01	2	CS	Clinical Sign	CLINICAL SIGNS	Pale	Pale	Color		2003-01-20T15:45:39	7	7
3	13456	CL	13456-01	3	CS	Clinical Sign	CLINICAL SIGNS	Squinting	Squinting	Facial	Both Eyes	2003-01-20T15:45:55	7	7
4	13456	CL	13456-02	1	CS	Clinical Sign	CLINICAL SIGNS	Salivation	Salivation	Facial		2003-01-28T15:44:42	15	15
5	13456	CL	13456-02	2	CS	Clinical Sign	CLINICAL SIGNS	Tremors	Tremors	CNS		2003-01-28T15:44:42	15	15

$warningHtml

Example

This example shows clinical signs captured in the collection system using categorization by CLTEST and having result categorization applied after collection for reporting purposes. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations and CLRESCAT is used to categorize each result.

Rows 1-3:	CLTESTCD and CLTEST are used to describe different tests whose results were recorded during the examination.
Rows 1-5:	CLRESCAT was used to categorize results during analysis for further categorization of data.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLRESCAT	CLLOC	CLDTC	CLDY	CLNOMDY
1	13456	CL	13456-01	1	AG	Activity/Gait	CLINICAL SIGNS	Difficulty Walking	Difficulty Walking	CNS		2003-01-20T15:44:42	7	7
2	13456	CL	13456-01	2	AC	Appearance and Condition	CLINICAL SIGNS	Pale	Pale	Color		2003-01-20T15:45:39	7	7
3	13456	CL	13456-01	3	EY	Eyes	CLINICAL SIGNS	Squinting	Squinting	Facial	Both Eyes	2003-01-20T15:45:55	7	7
4	13456	CL	13456-02	1	GO	General Observations	CLINICAL SIGNS	Salivation	Salivation	Facial		2003-01-28T15:44:42	15	15
5	13456	CL	13456-02	2	GO	General Observations	CLINICAL SIGNS	Tremors	Tremors	CNS		2003-01-28T15:44:42	15	15

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This example shows clinical signs captured in the collection system using categorization by CLSCAT or CLTEST. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations. CLSCAT further categorizes tests in the collection system.

CLTESTCD and CLTEST are used to describe different tests whose results were recorded during the examination. CLSCAT is used to break tests into multiple categories as recorded during examination.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLSCAT	CLORRES	CLSTRESC	CLLOC	CLSEV	CLDTC	CLDY	CLNOMDY
1	13456	CL	13456-01	1	FE	Fur Examination	CLINICAL SIGNS	Whole Body Appearance	Piloerection, mild	Piloerection		Mild	2003-01-20T15:44:42	7	7
2	13456	CL	13456-01	2	FE	Fur Examination	CLINICAL SIGNS	Whole Body Appearance	Stained, yellow	Stained			2003-01-20T15:45:39	7	7
3	13456	CL	13456-01	3	EE	Eye Examination	CLINICAL SIGNS	Sensory Organ Appearance	Red	Red			2003-01-20T15:45:55	7	7
4	13456	CL	13456-02	1	FE	Fur Examination	CLINICAL SIGNS	Whole Body Appearance	Stained, yellow	Stained			2003-01-28T15:44:42	15	15
5	13456	CL	13456-02	2	OE	Oral Examination	CLINICAL SIGNS	Sensory Organ Appearance	Missing tooth, right, bicuspid	Missing tooth	Right bicuspid		2003-01-28T15:44:42	15	15

$warningHtml

Example

This example shows clinical signs captured in the collection system using categorization with CLCAT. CLTESTCD and CLTEST are simply "Clinical Signs" for all entries in this example. Examples show results for 2 animals caged together, so POOLID and not USUBJID is populated. The POOLDEF table (see Section 2.8.9.22, SEND Pool Definition (POOLDEF)) TOBA-277 - Getting issue details... STATUS is shown below.

Rows 1-7: CLCAT is used to categorize the clinical signs into a controlled list and CLSTRESC is used to enter only the finding without modifiers.

cl.xpt

Row	STUDYID	DOMAIN	POOLID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLLOC	CLSEV	CLDTC	CLDY	CLNOMDY
1	ABC1	CL	CAGE1	1	CS	Clinical Signs	CLINICAL SIGNS	Skin, Red, Pinna, Left	Skin, Red	Pinna, Left		2003-01-20T15:44:42	7	7
2	ABC1	CL	CAGE1	2	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover, Hindpaw, Left	Fur, Thin Cover	Hindpaw, Left		2003-01-20T15:45:39	7	7
3	ABC1	CL	CAGE1	3	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover, Hindpaw, Right	Fur, Thin Cover	Hindpaw, Right		2003-01-20T15:45:55	7	7
4	ABC1	CL	CAGE1	4	CS	Clinical Signs	CLINICAL SIGNS	Conjunctival Hyperemia, Moderate	Conjunctival Hyperemia	Eye	MODERATE	2003-01-28T15:44:42	15	15
5	ABC1	CL	CAGE1	5	CS	Clinical Signs	CLINICAL SIGNS	Feces, Watery	Feces, Watery			2003-01-28T15:44:42	15	15
6	ABC1	CL	CAGE1	6	CS	Clinical Signs	CLINICAL SIGNS	Feces, Mucoid	Feces, Mucoid			2003-01-28T15:44:42	15	15
7	ABC1	CL	CAGE1	7	CS	Clinical Signs	CLINICAL SIGNS	Feces, Liquid (TS),Slight	Feces, Liquid		SLIGHT	2003-01-28T15:44:42	15	15

$warningHtml

$titleHtml

pooldef.xpt

Row	STUDYID	POOLID	USUBJID
1	ABC1	CAGE1	ABC1-1001
2	ABC1	CAGE1	ABC1-1002

$warningHtml

Example

This example shows clinical signs captured in the collection system using categorization. CLTESTCD and CLTEST are simply "Clinical Signs" for all entries in this example. Time points are included to indicate the signs that were taken for post-dose periods.

Rows 1-6:	CLCAT is used to categorize the clinical signs into a controlled list.
Rows 1-6:	CLTPT is used to specify the observation session in which the observations were collected. CLELTM was not included because this session was not specified in terms of elapsed time after dosing.
Row 6:	CLUSCHFL is used to specify that the observation was unscheduled. Note that CLNOMDY was populated with the actual study day for tabulation. CLNOMLBL reflects the label that was used in the study report.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLLOC	CLUSCHFL	CLDTC	CLDY	CLNOMDY	CLNOMLBL	CLTPT	CLTPTNUM
1	ABC1	CL	ABC1-1001	1	CS	Clinical Signs	CLINICAL SIGNS	Skin, Red	Skin, Red	Pinna, Left		2004-07-19T07:21:39	7	7	Day 7	Postdose 1	1
2	ABC1	CL	ABC1-1001	2	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Left		2004-07-19T07:16:57	7	7	Day 7	Postdose 1	1
3	ABC1	CL	ABC1-1002	1	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Right		2004-07-19T07:27:01	7	7	Day 7	Postdose 1	1
4	ABC1	CL	ABC1-1001	3	CS	Clinical Signs	CLINICAL SIGNS	Skin, Red	Skin, Red	Pinna, Left		2004-07-19T02:21:39	7	7	Day 7	Postdose 2	2
5	ABC1	CL	ABC1-1001	4	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Left		2004-07-19T02:16:57	7	7	Day 7	Postdose 2	2
6	ABC1	CL	ABC1-1002	2	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Right	Y	2004-07-19T04:15:01	7	7	Day 7 Unscheduled

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This example shows clinical signs categorized by CLTEST, with CLEVAL used to specify the role of the person who performed the examination. Physical examinations were captured in the collection system using categorization by CLTEST but not by CLCAT. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations.

Rows 1-5:	All CLTESTCD and CLTEST values reflect a physical examination.
Rows 1-5:	CLEVAL is used to specify that a veterinarian performed the examination.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLLOC	CLEVAL	CLSEV	CLDTC	CLDY	CLNOMDY
1	13456	CL	13456-01	1	OE	Oral Examination	PHYSICAL EXAM	Teeth broken	Teeth broken		VET		2005-12-15T09:15:16	1	1
2	13456	CL	13456-01	2	EA	External Appearance	PHYSICAL EXAM	Hordeolum, Mild, Right Eye	Hordeolum	Right Eye	VET	Mild	2005-12-15T09:20:42	1	1
3	13456	CL	13456-01	3	EA	External Appearance	PHYSICAL EXAM	Material around eyes, Red, Left Eye	Material around eyes, Red	Left Eye	VET		2005-12-15T09:22:51	1	1
4	13456	CL	13456-02	1	PS	Pelage/Skin	PHYSICAL EXAM	Skin discolored	Skin discolored		VET		2005-12-16T07:02:58	2	2
5	13456	CL	13456-02	2	RE	Respiration	PHYSICAL EXAM	Breathing difficult, Severe	Breathing difficult		VET	Severe	2005-12-16T07:02:58	2	2

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This example shows ophthalmoscopic examinations captured in the collection system using no result categorization applied after collection for reporting purposes.

Rows 1-5: CLTESTCD and CLTEST are also recorded as simply "Ophthalmoscopic Examination". CLEVAL is used to specify that an ophthalmologist performed the examination.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLLOC	CLEVAL	CLSEV	CLDTC	CLDY	CLNOMDY
1	13456	CL	13456-01	1	OP	Ophthalmoscopic Examination	OPHTHALMOLOGY	Nictitating membrane protruding, Left Eye	Nictitating membrane protruding	Left Eye	OPHTHALMOLOGIST		2005-12-15T09:15:16	1	1
2	13456	CL	13456-01	2	OP	Ophthalmoscopic Examination	OPHTHALMOLOGY	Chorioretinal hypoplasia, Moderate, Both Eyes	Chorioretinal hypoplasia	Both Eyes	OPHTHALMOLOGIST	Moderate	2005-12-15T09:20:42	1	1
3	13456	CL	13456-01	3	OP	Ophthalmoscopic Examination	OPHTHALMOLOGY	Conjunctivitis, Mild, Right Eye	Conjunctivitis	Right Eye	OPHTHALMOLOGIST	Mild	2005-12-15T09:22:51	1	1
4	13456	CL	13456-02	1	OP	Ophthalmoscopic Examination	OPHTHALMOLOGY	Retinal atrophy, Severe, Left Eye	Retinal atrophy	Left Eye	OPHTHALMOLOGIST	Severe	2005-12-16T07:02:58	2	2
5	13456	CL	13456-02	2	OP	Ophthalmoscopic Examination	OPHTHALMOLOGY	Iritis, Mild, Both Eyes	Iritis	Both Eyes	OPHTHALMOLOGIST	Mild	2005-12-16T07:02:58	2	2

$warningHtml

Example

This example shows clinical signs captured in the collection system using categorization. CLTESTCD and CLTEST are simply "Clinical Signs" for all entries in this example. Reference time points are included to indicate that the signs being taken are for a certain duration post-dose.

Rows 1-6: CLTPT is used to specify the observation session in which the observations were collected. CLELTM is included to signify that the measurements were planned at 15 minutes and 8 hours post-dose.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLLOC	CLDTC	CLDY	CLNOMDY	CLTPT	CLTPTNUM	CLELTM	CLTPTREF	CLRFTDTC
1	ABC1	CL	ABC1-1001	1	CS	Clinical Signs	CLINICAL SIGNS	Skin, Red	Skin, Red	Pinna, Left	2004-07-19T07:21:39	1	1	15 minutes Postdose	1	PT15M	Day 1 Dose	2004-07-19T07:05:00
2	ABC1	CL	ABC1-1001	2	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Left	2004-07-19T07:22:57	1	1	15 minutes Postdose	1	PT15M	Day 1 Dose	2004-07-19T07:05:00
3	ABC1	CL	ABC1-1002	1	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Right	2004-07-19T07:27:01	1	1	15 minutes Postdose	1	PT15M	Day 1 Dose	2004-07-19T07:05:00
4	ABC1	CL	ABC1-1001	3	CS	Clinical Signs	CLINICAL SIGNS	Skin, Red	Skin, Red	Pinna, Left	2004-07-19T15:05:39	1	1	8 Hours Postdose	2	PT8H	Day 1 Dose	2004-07-19T07:05:00
5	ABC1	CL	ABC1-1001	4	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Left	2004-07-19T15:05:57	1	1	8 Hours Postdose	2	PT8H	Day 1 Dose	2004-07-19T07:05:00
6	ABC1	CL	ABC1-1002	2	CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover	Fur, Thin Cover	Hindpaw, Right	2004-07-19T15:05:01	1	1	8 Hours Postdose	2	PT8H	Day 1 Dose	2004-07-19T07:05:00

$warningHtml

Example

Clinical sign related to a finding in anther domain. This example shows 2 unrelated clinical signs: thinning fur on the left hindpaw and swelling seen on the animal that then was determined to be a mass. A RELREC example is used to tie the record for the mass to an Macroscopic Findings (MA) record.

Row 1: CLSPID is used to identify the mass on the animal's jaw.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLSPID	CLTESTCD	CLTEST	CLCAT	CLORRES	CLSTRESC	CLLOC	CLDTC	CLDY	CLNOMDY
1	PY001002	CL	AA-12012	1065	MASS1	CS	Clinical Signs	CLINICAL SIGNS	Swelling; Left Jaw	Swelling	Left Jaw	2004-07-19	42	42
2	PY001002	CL	AA-12012	1066		CS	Clinical Signs	CLINICAL SIGNS	Fur, Thin Cover; Left Hindpaw	Fur, Thin Cover	Left Hindpaw	2004-07-19	42	42

$warningHtml

RELREC

$titleHtml

relrec.xpt

Row	STUDYID	RDOMAIN	USUBJID	POOLID	IDVAR	IDVARVAL	RELTYPE	RELID
1	PY001002	CL	AA-12012		CLSEQ	1065		62
2	PY001002	MA	AA-12012		MASEQ	233		62

$warningHtml

Example

This example shows food consumption within the CL domain when it is collected as text and reported as a qualitative measure.

Row 1:	Shows a record collected as an unscheduled observation when it is abnormal.
Row 2:	Shows a record collected as part of the routine observations as defined in the protocol.

cl.xpt

Row	STUDYID	DOMAIN	USUBJID	CLSEQ	CLTESTCD	CLTEST	CLCAT	CLSCAT	CLORRES	CLSTRESC	CLLOC	CLUSCHFL	CLDTC	CLDY	CLNOMDY
1	654321	CL	654321_101	1	BEAC	BEHAVIOR/ACTIVITY	CLINICAL SIGNS	UNSCHEDULED	Inappetence	INAPPETENCE		Y	2013-06-14T13:41:18	141	141
2	654321	CL	654321_101	2	BEAC	BEHAVIOR/ACTIVITY	CLINICAL SIGNS	ROUTINE	Inappetence	INAPPETENCE			2013-06-15T08:01:10	142	142

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

« Body Weight (BW)

Death Diagnosis and Details (DD) »

Page tree

Clinical Observations (CL)